Career Category

Job Description

Amgen is searching for a Director, Diagnostic Strategy Lead located in China. This individual will be a member of the global Diagnostics team responsible for the development and implementation of Diagnostic (Dx) development strategy across therapeutic areas for the China market.

Integral to the ongoing success of Amgen’s growing pipeline, the Diagnostics (Dx) Group is responsible for the successful transition of a biomarker assay to marketed Diagnostic to support the clinical development strategy for regulatory approval and commercialization.

As such, the Dx group works closely with other functions within Amgen to identify the appropriate partners for diagnostic test development.  We are looking for individuals with experience in driving end – to – end diagnostic development strategies and developing Dx life cycle management plans in China that align to the needs of their corresponding precision therapeutics programs across therapeutic areas.  The Diagnostic Strategy Lead role will be a critical strategic role at Amgen requiring a breadth of technical and business communication expertise, influencing decision-making through negotiation, and addressing conflict by building productive working relationships across functional areas both within and outside the company.  This individual will be working with the global and the local cross-functional teams to drive the development and execution of the Dx strategy and plan.

The primary responsibility of the successful candidate will be to develop comprehensive Dx strategies for the China market across therapeutic areas and to ensure those programs are fully aligned with global Dx and clinical development strategies.

Responsibilities:

• Lead the development of the end–to–end diagnostic development strategies to support therapeutic product teams in China.
• The development and successful implementation of global strategic diagnostic development life cycle plans, programs and initiatives to support approval and commercialization of diagnostics which will support the therapeutic life cycles.
• Developing business cases, driving the strategic evaluation of diagnostic development options and technologies, diagnostic market landscape assessment in China.
• Working with key cross-functional stakeholders to integrate diagnostic development, approval and launch strategies for the product teams together with third-party diagnostic partners and ensuring successful execution of the overall Dx strategy for China.
• Work closely with local regulatory team to ensure that the Dx plan meets local regulatory requirements.
• Ensuring that the diagnostic strategy incorporates global requirements for execution and success.
• Working closely with global and regional marketing teams, and other cross functional partners and stakeholders, to deliver and implement diagnostic business strategies for China.

Basic Qualifications:

Doctorate degree and 4 years of pharmaceutical and/or diagnostics experience
OR
Master’s degree and 8 years of pharmaceutical and/or diagnostics experience 
OR
Bachelor’s degree and 10 years of pharmaceutical and/or diagnostics experience
AND
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• 5+ years of experience in the Diagnostics industry
• 4+ years of cross-functional leadership experience leading teams, projects, programs or directing the allocation of resources
• Proven experience developing strategic initiatives and gaining stakeholder alignment at all levels in the organization
• Highly effective presentation / communication skills at the senior / /executive management level
• Experience in precision medicine development and / or in vitro diagnostics development
• Experience in companion diagnostics development and knowledge of regulatory submission requirements of in vitro diagnostic devices in multiple markets
• Knowledge and experience in clinical trial design
• Experience integrating data from multiple sources and identifying critical process variables
• Experience establishing and reviewing complex plans for multiple projects or activities. This includes planning / reviewing resource allocation, complex timeline development, risk identification / mitigation

At Amgen, our mission is serving patients. Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our “people-first” philosophy. We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business.

Consistent with our core leadership value of “Develops the Best Team,” we are seeking leaders that prioritize the development of talent. As a manager, your first priority and primary role is to accelerate the performance and development of your team. We expect managers to exemplify strong leadership and champion self-awareness and career development Ways that you will display your leadership acumen in this role include:

• Mentoring, coaching, and developing staff to build highly-skilled, diverse, and inclusive teams
• Fostering a positive and respectful work environment that encourages staff retention and motivates individuals to work toward common goals and priorities
• Ensuring that staff understand how their efforts and contributions make a meaningful impact to the business
• Growing core skills and capabilities among staff, particularly in learning agility, problem solving, strategic and creative thinking, flexibility, resilience, effective communication, prioritization, delivery of results, and continuous improvement
• Making accurate evaluations of your team's skills and competencies and providing timely and respectful feedback, including direct delivery of difficult messages
• Developing an understanding of your team's career objectives and serve as a thought-partner in their career development plans
• Assisting staff with preparing for roles of growing responsibility and identifying new opportunities that expand their skills and align with their overall career objectives
• Resolving critical gaps in the organization’s internal capabilities and skill sets, including strategic external recruiting
• Identifying diverse, qualified successors for key positions
• Ensuring that direct reports who also lead people consistently demonstrate these same behaviors with their staff

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Director, Induced Proximity Platform - Large Molecule Modalities

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be a part of Amgen’s Induced Proximity Platform team. We are seeking an accomplished Director to lead our efforts to discover the next generation of novel large molecule induced proximity therapeutics. In this position you will lead a research team in the Induced Proximity Platform at the cutting edge of drug discovery to enable both platform technology development and enablement of pipeline programs. As a skilled organizational leader, this individual should be an efficient manager, a strong team builder and a collaborator who will provide robust organizational and scientific leadership consistent with Amgen’s culture of innovation and teamwork.

Responsibilities:

• Supervise a group engaged in developing platform technology for large molecule Induced Proximity modalities
• Contribute to the development and implementation of the research strategy in the Induced Proximity Platform, with a specific focus towards large molecules
• Deliver programs into our pipeline focused on induced proximity with large molecules
• Develop effective cross functional relationships with colleagues in therapeutic areas, including Oncology, Inflammation, Cardiometabolic, and Large Molecule Discovery

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Scientific professional we seek is ambitious collaborative leader with these qualifications.

Basic Qualifications:

Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 5 years of relevant industry experience

Or

Master’s degree and 8 years of relevant industry experience

Or

Bachelor’s degree and 10 years of relevant industry experience

Preferred Qualifications:

• A proven track record of scientific innovation and accomplishment in large molecule induced proximity modalities, as demonstrated by a strong publication record, patent submissions, and presentations at leading conferences.
• A deep understanding of ubiquitin biology, protein trafficking, protein degradation, proximity based therapeutics, and large molecule formats
• Demonstrated experience in advancing novel drug discovery programs from hit finding to preclinical evaluation
• An understanding of the emerging technologies being directed at hard to drug targets
• Strong written/verbal communication and interpersonal skills
• Experience in leading, mentoring and developing the careers of a diverse and talented team
• An ability to build strong and productive relationships with peers and cross functional partners

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Early Development Associate Medical Director, Inflammation Therapeutic Area

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for designing and executing early development clinical trials and leading the evidence generation teams. You will report into the Executive Director, Head of Early Development Inflammation and Rare Disease.

• Effectively network with internal and external opinion leaders

• Design and implement an early clinical development strategy for Inflammation indications (e.g., rheumatologic, respiratory, dermatologic, inflammatory bowel disease, other)

• Opportunity to explore additional therapeutic areas, e.g., rare diseases,

• Lead the preparation of clinical development plans and clinical study protocols, and contribute to informed consents, Investigator Brochures, and Ethics Committee and regulatory agency submissions

• Lead the Evidence Generation Team

• Review and evaluate clinical study safety, efficacy, pharmacodynamic and pharmacokinetic data

• Contribute to the strategy and use of clinical biomarkers to facilitate drug development

• Actively collaborate with Amgen Late Development, Discovery Research, Regulatory, and Commercial colleagues

• Collaborate with external experts to provide biomedical expertise and strategic guidance to inflammation early development teams

• Contribute to in-licensing evaluations and due-diligence activities

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 3 years of academic/basic sciences/clinical research experience

OR

Master’s degree and 5 years of academic/basic sciences/clinical research experience

OR

Bachelor’s degree and 7 years of academic/basic sciences/clinical research experience

OR

Associate’s degree and 12 years of academic/basic sciences/clinical research experience

OR

High school diploma / GED and 14 years of academic/basic sciences/clinical research experience

Preferred Qualifications:

• Board certification or eligible

• Residency training in Internal Medicine and relevant subspecialty

• 3+ years of Inflammation drug development experience in the pharmaceutical industry and/or substantial clinical trial

• Experience collaborating with pharmaceutical sponsors

• Experience in designing, monitoring and implementing clinical trials and interpreting trial results

• Demonstrated leadership qualities, capable of conducting studies as part of a team

• Experience within a matrix environment, contributes to decision-making and reaching alignment in order to meet timelines

• Experience in early clinical trials

• Experience in basic research and clinical trial methodology

• Publication track record

• Excellent interpersonal and presentation skills

• Communicate effectively with internal stakeholders, as well as external partners and collaborators

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Director, Oncology Research

Live

What you will do

Let’s do this. Let’s change the world. Amgen Oncology is advancing an innovative, multi-modality pipeline that aims to transform the cancer treatment landscape. We are seeking a creative, collaborative Director of Research who is driven to deliver next-generation BiTE® (bispecific T-cell engager) therapies.

In this vital role, you will be responsible to develop our strategy for new target discovery and validation, and to build a portfolio of preclinical T-cell engager assets focused on solid tumors. The Director will be closely involved in the identification and assessment of internal and external opportunities for technology and platform development to support this strategy. A deep understanding of cancer cell biology and human genetics, broad knowledge of the oncology competitive landscape, and experience with drug discovery and development across therapeutic modalities is required. This is a high visibility role.

Responsibilities:

• Work as part of a cross-functional team to identify strategic opportunities to build the portfolio;
• Identify, evaluate, and implement cutting-edge approaches for target identification and validation;
• Lead the advancement of high quality targets and assets in the early Oncology portfolio
• Develop a research team that includes laboratory-based staff, managers, and project team leaders;
• Establish and maintain external partnerships (academic and/or industry) and presence
• Present strategy, opportunities, and project updates to senior leadership
• Demonstrate critical thinking and efficient decision-making

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 5 years of related experience

Or

Master’s degree and 8 years of related experience

Or

Bachelor’s degree and 10 years of related experience

Preferred Qualifications:

• PhD in cancer biology, human genetics, biochemistry, or immunology with at least 10 years post-graduate experience
• Leadership style that is highly collaborative, inspires and develops talent at all levels, and puts patients and science first
• Deep understanding of cancer cell biology and therapeutic development
• Proven scientific accomplishment and innovation in oncology research as evidenced by high-impact publications, congress presentations and patents
• Experience leading academic or industry research collaborations
• Outstanding interpersonal and communication skills

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

Executive Director, Global Safety Head, Obesity

Live

What you will do

Let’s do this. Let’s change the world. In this vital role as the Executive Director, Global Safety Head, you will serve as the safety expert for Amgen’s obesity products globally and are accountable for the safety strategy and major safety deliverables for each product. You will lead the obesity safety teams and are accountable for the staff management and resource planning/allocation.

You will serve as a core member of Global Patient Safety Leadership team and will support the Head of Global Patient Safety (GPS) in the establishment of a highly effective global safety organization in full compliance with worldwide regulations.  This role reports into the Head of Global Patient Safety. 

Responsibilities:

• Serve as Safety expert in Obesity

• Accountable for providing strategic oversight and direction for all regulatory safety responses or strategic deliverables, including but not exclusive to Safety sections of NDA submissions, RMPs, PSURs, PBRERs, DSURs, DILs

• Leads the safety strategy and Benefit/Risk Management Process for assigned portfolio and ensures Therapeutic Area (TA) staff provides ongoing monitoring of safety profiles for Amgen products worldwide

• Chairs and participates in safety governance meetings per Standard Operating Procedures and Manuals

• Oversee Obesity Safety input to contractual agreements with Business Partners and CROs

• Works cross-functionally with Development and Regulatory TA Heads to reach issue resolution

• Provide safety oversight, strategy and guidance to therapeutic areas and other groups within Clinical Development, Medical Affairs, Regulatory and the commercial organizations

• Management of the Obesity safety teams providing direction and allowing appropriate prioritization of resources to achieve goals

• Recruit and retain talented safety professionals and provide coaching, mentoring, and development of staff

• Ensure staff are compliant with Amgen corporate and departmental training

• Contribute to Global Patient Safety goals in development

• Participate in budget and headcount planning

• Leads or sponsors significant cross-functional projects, initiatives or training

• Inspection Readiness

• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Executive Director we seek is an experienced leader with the following qualifications. They will also embody the Amgen leadership attributes which are:

• Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive

• Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection

• Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders

• Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results

Basic Qualifications:

• MD or DO degree from an accredited medical school AND

• Five (5) years of industry or academic research AND  

• Six (6) years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• PhD with 15 years of directly related experience

• Clinical experience in either an accredited academic setting or private practice (including hospital based) setting

• Previous product safety experience and knowledge of clinical trials and drug development

• Knowledge of Obesity patient populations and drug classes

• Proven history of effective leadership with a matrix organization

• Issue and crisis management

• Strategic leadership ability and capable to manage global teams and multifunctional teams to the accomplishment of complex interdepartmental & international programs and projects

• Understanding of international drug safety regulations, global pharmacovigilance and product safety processes

• Knowledge of general medicine, clinical care, and principles of epidemiology

• Influencing skills with capability to present strategies, policy & work processes to diverse audiences, geographies, departments, and organization levels

• Assisting staff with preparing for roles of growing responsibility and identifying new opportunities that expand their skills and align with their overall career objectives

• Resolving critical gaps in the organization’s internal capabilities and skillsets, including strategic external recruiting

• Identifying diverse, qualified successors for key positions

• Ensuring that direct reports who also lead people consistently demonstrate these same behaviors with their staff

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is $317,452 - $360,254.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Amgen’s Commitment to Our Staff

At Amgen, our mission is serving patients. Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our “people-first” philosophy. We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Medical Sciences Director - Early Development - Hematology/Oncology, US - Remote

Live

What you will do

Let’s do this. Let’s change the world. Amgen is advancing the largest early Oncology pipeline in our history spanning several innovative technology platforms – Bispecific T Cell Engagers (BiTE®s), Bispecific Antibodies, Small Molecules – across many targets and more than a dozen tumor types. We need collaborative and innovative world-class talent to ensure these molecules become medicines and reach their full potential while helping patients.

To support that effort, the Oncology Early Development Group is looking for a Medical Sciences Director.

In this vital role, the Medical Sciences Director will contribute to early phase clinical development of oncology compounds from first-in-human studies through proof of concept. They will collaborate on teams to define, design, and deliver early phase clinical and translational projects as the initial strategy for drug development. Through their role, the Medical Sciences Director provides subject matter expertise in data review and analysis.

Responsibilities:

• Assist with set up and execution of early phase clinical trials with a focus on data quality
• Responsible for providing input into & implementation of data management plan, CRF design, and data review oversight
• Accountable for review, analysis, and presentation of clinical trial data for internal decision making, external interactions, and regulatory submission
• Assists Early Development Lead in medical monitoring and management of oncology phase 1 collaborators, consultants, and/or Clinical Research Organizations in completion of key projects
• Anticipate and actively manage problems across a broad spectrum of cross-functional teams
• Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The medical professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 4 years of medical science experience
OR
Master’s degree and 7  years of  medical science experience 
OR
Bachelor’s degree and 9 years of medical science experience
 

Preferred Qualifications:

• 5 years of pharmaceutical clinical drug development experience
• Strong preference for individuals with proven track record of oncology clinical trial process improvement
• Industry or academic experience in early-phase oncology drug development
• Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally (both written and oral)
• Experience with designing, monitoring, and implementing oncology clinical trials and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements
• Understanding of conducting study data readout activities, including data cleaning, data base lock, data extract, producing outputs of data
• Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions
• Serving as a contributing author to scientific publications and data presentations at scientific conferences
• Experience in clinical data analysis such as Spotfire or other data analysis tools
   

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Senior Director - Translational Safety and Bioanalytical Sciences

Live

What you will do

Let’s do this. Let’s change the world. The Translational Safety and Bioanalytical Sciences (TS&BA) function at Amgen is exploring candidates for Senior Director to serve as a group leader for our team of TS&BA Therapeutic Area (TA) Strategy Leads and Business Development (BD) Liaisons.

In this vital role you will set and drive the strategic vision for the TA Strategy Lead and BD Liaison team, have ownership of pre-Product Team (PT) translational safety strategies and deliverables (including identification of resourcing needs, both in terms of capacity and capability), provide oversight for each monthly TS&BA TA Focus Group Meeting (one for each TA: Inflammation, Oncology, and Cardiometabolic Disease), contribute as a Senior Advisor on the TS&BA Portfolio Scientific Advisory Committee, act as delegate and advisor to the Executive Director (US and EU) Heads of TS&BA Portfolio Scientific Leadership for key meetings (e.g., the Research Science Advisory Forum [SAF], the TS&BA Portfolio Impact Meeting), represent TS&BA on R&D Initiatives, and actively contribute to the evolution of TS&BA to enable our rolling 3-year strategic vision. It is anticipated that the Senior Director will hold subject matter expertise and continue to develop as a subject matter expert (SME) in a particular area e.g., a toxicology specialty area, TA, or modality. The Senior Director will participate in external industry initiatives to improve drug safety assessment paradigms.

As the group leader for our TS&BA Strategy Leads and BD Liaisons, you will further develop the leadership skills of the team through coaching, identifying experiential learning opportunities, and ensuring individually tailored career developments plans are continuously evolved. In partnership with your team, you will influence the development of fit-for-purpose translational safety strategies based on a strong scientific foundation, flexibly evolve the strategy in response to team goals and emerging data and encourage effective team behaviors. A strong understanding of the expertise and toolbox available at Amgen will be developed through networking to fully use our internal and external resources. It is expected that you will apply your later-stage drug development and regulatory experience to the novel targets and/or modalities in Amgen’s pipeline.

The TS&BA TA Strategy Lead and BD Liaison roles are key strategic roles within TS&BA designed to ensure optimal communication between key TA partners and TS&BA, focus TS&BA on pre-Product Team (PT) TA projects or novel platforms with the right resources at the right time, oversee TS&BA due diligence reviews (end-to-end from Discovery through Life Cycle Management), and ensure deep expertise in TS&BA relevant to the TA to enable robust nonclinical safety strategies and regulatory submissions.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

7+ Years w/ Relevant PhD, PharmD, MD, or equivalent (and relevant post-doc where applicable)

Or

10+ Years w/ Relevant MS or equivalent

Or

12+ Years w/ Relevant BS or equivalent

Preferred Qualifications:

• 15 years of drug development experience including interactions with global Health Authorities; ideally including late-stage assets and interactions with global regulatory agencies for IND/CTA and NDA/BLA/MAA filings and application of this experience to early pipeline projects and platforms.
• Experience with leading and mentoring a team of nonclinical translational safety project team representatives through both direct and matrix management.
• Comfortable with setting and driving functional strategy and leading cross-functional teams through implementation.
• End-to-end small and large molecule safety assessment experience across multiple therapeutic areas and modalities including small molecules, antibody drug conjugates and T-cell engagers.
• Expertise in developing nonclinical safety strategies for new modalities or to address unique safety concerns and resolving safety-related issues.
• External visibility as a toxicology expert as demonstrated by a strong external presentation and publication record.
• Diplomate of the American Board of Toxicology or another relevant certification, e.g., Diplomate, American College of Veterinary Pathologists (DACVP).

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Biostatistics Associate Director

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will achieve results through detailed goal setting, accountability measures, effective partnership, performance management, collaboration with other groups and a dedication to serving customers, both inside and outside of, CfDA (Center for Design & Analysis). The Associate Director Biostatistics independently leads sophisticated studies and projects in the General Medicine therapeutic areas (Cardiometabolic, Inflammation, Nephrology, and Neuroscience), ensuring that the statistical aspects of clinical activities meet required standards and are robust and valid. Will also influence and supply to strategy development, defend statistical approaches and represent GBS (Global Biostatical Science) through participating in and collaborating with multidisciplinary project teams. Specific duties include:

• Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs.
• Implementing, managing and supporting standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
• Planning and executing statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs).
• Providing input for clinical publications and regulatory filing documents.
• Leading all aspects of work performed by study statisticians.
• Performing statistical and exploratory analysis of studies/projects and developing conclusions and recommendations.
• Anticipating and communicating resource and quality challenges that could impact results or timelines.
• Staying current in developments in the field of statistics in drug development (innovative trial design) and Amgen’s statistical policies, procedures and strategies.
• Contributing to process improvements and operational efficiencies.

WHAT WE EXPECT OF YOU

We are all different, yet we all use our unique contributions to serve patients. The Biostatistical professional we seek is an emerging leader with these qualifications.

Basic qualifications

• Doctorate degree and 2 years of experience OR Master’s degree and 6 years of experience OR Bachelor’s degree and 8 years of experience OR Associate’s degree and 10 years of experience OR High school diploma / GED and 12 years of experience

PREFERRED QUALIFICATIONS

• Doctorate degree in biostatics or statistics.
• 7 or more years of pharma/biotech statistical experience.
• Life cycle drug development experience (pre-clinical, clinical and post-marketing).
• Proven in leadership and motivating multi-functional team to advance complex projects to completion and thoughtfully negotiate and influence
• Strong verbal and written communication combined with organizational skills and cross- cultural sensitivity
• Statistical leadership and contribution to regulatory and reimbursement submissions.
• Strong working knowledge of theoretical and applied statistics and of regulatory guidelines.
• Prior experiences in metabolic disease area development

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Clinical Research Medical Director, Inflammation

Live

What you will do

Let’s do this. Let’s change the world. The Inflammation Therapeutic Area within Global Development is rapidly growing and in this vital role you will have an opportunity to shape this Therapeutic Area. This role will report directly to the Global Development Lead for a program. The position is US - Remote.

Responsibilities:

• Serve as clinical expert to provide clinical/scientific knowledge into the development, execution and communication of the global scientific/medical evidence plan for the indication(s).

• Provide oversight of LCM clinical development with input on global strategy
• Support cross-functional and global collaborations to integrate broad medical, regulatory, safety, scientific, and commercial access and value input into the development program(s)

• Participate and provide clinical input into safety and regulatory interactions

• Interpret and communicate clinical trial data

• Author/review CSRs, publications and regulatory submissions

  Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL

• Identify new clinical research opportunities

• Support in-licensing and out-licensing activities and partner relationships Support product lifecycle management for new indications as directed by Global Development Lead

• Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization

• Approximate 10% travel may be require

• Potential managerial role, seeking and developing talent in past will be a plus

Knowledge:

• In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale

• In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials in all phases of development esp Ph2/3 registrational trials

• Medical knowledge in the relevant therapeutic area

• Sound scientific and clinical judgment

• Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups

• Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements

• Prior experience of regulatory interactions, authoring filing IND or BLA experience

• Understanding of new drug commercialization and business practices

• Understanding of resourcing and budgeting

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Medical professional we seek is a leader with these qualifications.

Basic Qualifications:

MD or DO degree from an accredited medical school

AND

2 years of clinical research experience and/or basic science research

Preferred Qualifications:

• MD plus accredited residency in relevant sub-specialty, board certified or equivalent.
• Three (3) or more years of clinical development experience and/or basic science research combined with clinical teaching and patient care activities.
• Clinical development experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
• Experience in development lifecycle management to include development strategy creation for large programs from early development, through late development and commercialization.
• Involved in filing activities as part of the moving the program through the development lifecycle.
• Key relationship development and collaboration with the expansive commercial and medical teams internal and external partners and key opinion leaders.
• Previous management experience of clinical development professionals

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is $256,334. - $318,868.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Global Asset Lead Medical Director, Oncology Solid Tumor Pipeline, US-Remote

Live

What you will do

Let’s do this. Let’s change the world. In this vital role the Global Asset Lead Medical Director, Oncology Solid Tumor Pipeline will be accountable for development and execution of the global medical affairs strategy for one of Amgen's promising solid tumor pipeline assets. The Asset Lead Medical Director will also be accountable for Global Medical Affairs Team (GMAT) with the objective of maximizing Amgen’s value proposition.

Responsibilities:

• Lead the cross-functional and cross-regional development of the global medical affairs strategies for one of Amgen's pipeline asset through the GMAT
• Provide support for the development and execution of the clinical development plan
• Actively provide insights and support the development of the early Target Product Profile
• Coordinate with the regions to develop and lead the external stakeholder management plan, communication strategy, scientific platform, publication plan and evidence generation plans
• Develop robust external stakeholder engagement and insight gathering to strengthen understanding of the unmet need and maximize medical value of the asset
• Enhance Amgen’s reputation as a science-based and patient focused reliable partner
• Partner on evidence generation and ensure key regional/local needs are addressed

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The medical professional we seek is a leader with these qualifications.

Basic Qualifications:

MD/DO degree from an accredited medical school OR PhD OR PharmD

AND

2 years of Medical Affairs experience in Hematology-Oncology

Preferred Qualifications:

• MD plus accredited fellowship in Oncology, board certified or board eligible
• Clinical and disease knowledge base in solid tumor (specifically thoracic or I-O)
• 4+ years Hematology or Oncology Medical Affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers
• 2+ years of clinical research experience and/or basic science combined with clinical teaching and patient care activities
• Familiarity with global regulatory organizations, guidelines, and practices
• Knowledge of Good Clinical Practices (GCP) and global regulations and guidelines
• History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
• Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes, including but not limited to, clinical operations, commercial, regulatory, and medical affairs

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is $232,290. to $284,490.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Scientific Associate Director – Translational Pathology

Live

What you will do

Let’s do this. Let’s change the world. The use of Biomarkers and Diagnostics is central to understanding how our therapeutics work and identifying patients that benefit most from these therapies. Accordingly, the Clinical Biomarkers & Diagnostics (CBD) function plays a critical role in advancing our drug development programs and is accountable for the development of biomarker and diagnostics strategy across our pipeline. The Translational Pathology group within CBD is responsible for implementing the biomarker and diagnostics strategy. We are seeking a highly motivated individual to help drive tissue-based assay development, implementation, and analysis. This individual will work closely with internal groups and external CROs/collaborators for tissue-based biomarker and companion diagnostics assay development and implementation.

This position will report directly to the Executive Director of Translational Pathology and be responsible for implementation of translational tissue-based biomarkers especially patient selection and possibly assisting with pharmacodynamic, mechanism of resistance assays.

Responsibilities:

• Provide leadership and technical expertise in translational and experimental pathology
• Lead efforts to develop tissue-based assays for diagnostics development
• Provide technical input to project teams and ensure access to state-of-the-art tissue-based techniques and samples for target pathway validation in human disease
• Responsible for design, validation and deployment of pathology assays including determination of assay parameters
• Develop, validate, and implement tissue-based assays for use in clinical trials especially for prospective patient selection

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a Director with these qualifications.

Basic Qualifications:

Doctorate degree and 3 years of translational and/or experimental pathology experience or

Master’s degree and 5 years of translational and/or experimental pathology experience or

Bachelor’s degree and 7 years of translational and/or experimental pathology experience

Associate’s degree and 12 years of translational and/or experimental pathology experience or

High school diploma / GED and 14 years of translational and/or experimental pathology experience

Preferred Qualifications:

• A track record with credible publications and strong experimental Pathology supporting research:
• Demonstrated expertise in tissue-based analysis such as in situ hybridization, immunohistochemistry, fluorescence applications
• Expertise with human diseases and experimental mouse models
• Expertise with image analysis software and algorithm design
• In depth experience with the discovery, characterization, clinical validation and utilization of tissue-based diagnostics:
• Awareness of the challenges of implementing tissue-based biomarker and diagnostic technologies in the clinical setting
• Direct experience in development, outsourcing and validation of clinically applicable tissue-based diagnostic assays
• Demonstrated excellence in independently conducting relevant experiments and ability to summarize information/data in a concise, easy to understand manner
• Excellent collaboration skills including mentoring, motivation and delegation
• Excellent verbal and written communication and presentation skills
• High level of initiative and ability to work independently
• High level of business awareness

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Medical Director, Global Asset Lead, Obesity and Cardio-Metabolism, US- Remote

Live

What you will do

Let’s do this. Let’s change the world. In this vital role the Global Asset Lead Medical Director will be accountable for the development and execution of global medical affairs strategy for Obesity and Cardio-Metabolism.

Responsibilities:

Strategy Development and Implementation:

• Contribute to the development and execution of the global medical affairs strategy for maridebart cafraglutide.
• Serve as the Medical Affairs Representative on various global strategic teams.
• Support the development of the integrated evidence generation plan for obesity and cardio-metabolism.
• Capture clinical/scientific insights across all key markets and translate them into concrete strategies.
• Facilitate scientific engagements across a broad range of partners (e.g. KOLs, Professional Organizations, Payers, Regulators)
• Align and implement strategy for medical communications and related activities.
• Develop medical strategic plans and ensure consistent execution of outputs through Medical Affairs Teams.
• Provide strategic direction for study design and execution for medical affairs and other global studies.
• Enable access to medicines through clear understanding and education of treatment value.
• Facilitate and continue to build Amgen’s role as a science-based, patient-focused partner.
• Provide input to Value Dossiers.
• Determine resource and budget allocation necessary to deliver on medical strategies.

Collaboration and Coordination:

• Cultivate and improve collaboration and coordination across medical functions.
• Lead/support relationships with the external healthcare community.
• Serve as a medical representative in leadership, governance, and cross-functional teams.

Evidence Generation and Communication:

• Provide insights to Amgen's Safety and Benefit/Risk profile of the molecule.
• Support evidence generation that shapes the therapeutic area and informs the practice of medicine.
• Synthesize and integrate insights to deliver medical inputs into cross-regional/functional strategies.
• Review, approve, and ensure dissemination of medical communications and related activities.
• Lead or support advisory boards and other meetings.

Compliance and Performance:

• Ensure conduct of medical activities in full compliance with all laws, regulations, and SOPs.
• Use global infrastructure for tracking, measuring, and evaluating performance and ensuring continuous performance improvement.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The ideal candidate we seek is a team player that can adapt easily to a fast-changing environment and possesses the following qualifications:

Basic Qualifications:

MD or DO degree from an accredited medical school OR PhD OR PharmD

AND

2 years of clinical research experience and/or basic science research in obesity and/or cardio-metabolism.

Preferred Qualifications:

• 3 years of clinical research and/or medical affairs experience in a leadership role
• Clinical experience and disease knowledge base in obesity and/or cardio-metabolism
• MD plus accredited fellowship in Cardiology, Endocrinology, Obesity, Internal Medicine or related medical field. Board-certified or board eligible
• Minimum 5 years of Medical Affairs experience in industry (biotech, pharmaceutical or CRO)
• Experience in building Integrated Evidence Generation Plans
• Ability to establish interactions and engagements with partners (e.g., Opinion Leaders, advocacy groups, patients, payers, vendors)
• Familiarity with global regulatory organizations, guidelines, and practices
• Knowledge of Good Clinical Practices (GCP) and global regulations and guidelines
• Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes, including but not limited to, clinical operations, commercial, regulatory, and medical affairs
• History of solving problems while exhibiting sound scientific/medical judgment and a balanced, realistic understanding of issues
• Good understanding of healthcare systems around the world (e.g. US, EU, Asia)
• Track record of success working with matrixed cross-functional teams

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is $232,290. - $284,490.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Biostats Director

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will Serve as CfDA TA stat liaison to drive the statistical perspective in Clinical Data Hub (CDH) related initiatives.

• Develops strong partnership with cross functional CDH team leaders and serve as CfDA TA statistical liaison to ensure strong support to the Precision Medicine related initiatives and alignment among related CfDA functions.
• Provides regular updates and awareness communication to the CfDA Senior/Extended Leaders (SLT/ELT) and Global Statistical Leads (GSL) on CDH progression (e.g. implementing data access in clinical trial under CDH)
• Advocates clinical trial integrity from analytical perspective to enable “Right people provide Right answers for Right questions at Right time”.
• Promotes awareness and adoption of new reliable advancement in clinical trial CDISC dataset creation, analysis and reporting

Other Biostatistical Director Responsibilities:

• Partner with various CfDA functions to drive novel and fit-for-purpose statistical approaches, standards, technical quality, study design, analysis, interpretation and evidence synthesis in balance with speed, quality, and cost for designated products / programs that could optimize the data & analytics in precision medicine area.
• Partner with Strategic Development Director / Director, Statistical Innovation / EDL / GDL / / Precision Medicine team and other analytical groups within R&D to define the research questions, data and evidence requirements for product lifecycle (including reverse translation)
• Function as a TA stat leader (e.g. GSL, SLS) to oversee statistical contributions to key design elements, protocols, randomization specifications, statistical analysis plans, tables, figures and listings shells, submission data file specifications, and other key product-related documentation
• Partner with evidence-related, cross-functional stakeholders to ensure the highest statistical standards and integrity and provide program level statistical support for HTAs and payer negotiations, regulatory submissions RTQs, safety and benefit-risk assessment, and scientific publications
• Resource Management for the assigned project(s)

Additional Job Description

Basic Qualifications

Doctorate degree and 4 years of experience

OR

Master’s degree and 8years of experience

OR

Bachelor’s degree and 10 years of experience

Preferred Qualifications

• Statistical leadership or participation on regulatory submissions with CDISC datasets
• Independent leadership of multiple projects
• Doctorate (or Master’s) degree in Statistics/Biostatistics or related subject with high statistical content and at least 8 (or 10) years of post-graduate statistical experience in the pharmaceutical industry or medical research
• Experience in developing policies and SOPs
• Leadership skills of cross-functional teams and initiatives
• Drive for innovation and quick adaptation to new industry trends

Scientific / Technical Excellence:

• Superior understanding of clinical trial integrity related statistical principles, methods, applications, and procedures
• Leads and instructs others in statistical areas relating to randomized and non-randomized clinical research
• Deep understanding of drug development process and operations
• Highly proficient in biostatistical software

People / Project Management:

• Communicates complex and nuanced information in a concise and impactful way —including to lay audiences
• Successfully leads cross-functional teams across geographies;

Able to navigate in a large global, matrixed organization

• Demonstrates ability to identify and adapt to shifting priorities and competing demands
• Manages teams (including external service providers) to tasks and timelines

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range