ROLE SUMMARY

• The clinician medical monitor may contribute towards providing medical and scientific expertise and oversight for Clinical Trials.

• The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain worldwide approval for a compound or group of compounds.

ROLE RESPONSIBILITIES

Accountable for safety across the study:

• Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level.
• Ensures development of and adherence to the Safety Surveillance Review Plan (SSRP). Consistent with the SSRP, performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead. As appropriate, the clinician medical monitor may delegate these responsibilities to the study clinician scientist identified in the SSRP. The specific components of safety data review are detailed in the appropriate SOPs and the “Safety Data Review Guide – for Clinicians.”
• Monitor study safety issues and provide input to serious adverse events (SAEs) reports. Provides appropriate medical context in terms of risk factors, medical history and other important medical factors required to put the SAE or AE into appropriate medical context.
• Participates in the Safety Review Team to evaluate medical benefits/risks to support targeted clinical indications.
• Reviews literature as needed to respond to safety questions or those posed by the Safety Review Team, Data Monitoring Committee (DMC) or other individuals or bodies involved with the study.
• Communicates safety information to sites across the study and provides responses to questions on safety.

Protocol design and strategy:

• Contributes towards the medical input during protocol development and updates to the clinical development plan.
• Work closely with other medical monitors to ensure that documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy and has been reviewed by IRB/IECs.
• Provides medical input into country feasibility.

Support study team

• With supervision of medical monitor (director/Sr director) provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed
• Contributes to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied.
• Works with study team to ensure high quality of data e.g. appropriate patient population, adequacy of clinical assessments as study is ongoing.
• Contributes to medical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness of analysis and reporting.
• Provides protocol specific training to study team, investigators, clinical research associate, and others.
• Interacts with healthcare professionals at sites during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level.
• Interacts with DMCs and steering committees as required.
• Notifies appropriate study team personnel of the need to inform investigators of any changes in research activity and any significant new adverse events.
• Monitor investigator compliance with protocol and regulatory requirements.
• Support study team in issues resolution, study closeout, audit responses, inspection readiness, etc.

• Supports the program team:
• Under supervision (director/Sr director) authors clinical sections of regulatory documents (Investigator Brochure, Annual Reports, Investigational New Drug sections, clinical study report).
• May co-author abstracts, posters, presentations and publications.
• May contribute budget execution of protocols.

Interact with regulatory authorities, key opinion leaders, and principal investigators:

• May support Clinical Regulatory Authority interactions accountable for providing responses.
• Liaise with Key Opinion Leaders and Principal Investigators in countries to build a Key Opinion Leaders /Principal Investigators network for new trials.

BASIC QUALIFICATIONS

• Licensed by a health authority to prescribe medicines (independent of supervision) for at least one year (post "intern/houseman" year) and has utilized the license to prescribe medicines in a patient care setting for an aggregate duration of at least one year.
• Possesses the ability to critically evaluate medical/scientific information.
• Excellent written an oral communication.
• Understands the design, development, and execution of clinical programs and studies.
• Capacity to adapt to a fast pace and changing environment

PREFERRED QUALIFICATIONS

• Medical degree (M.D./D.O. or equivalent).
• Documented work experience/knowledge of statistics
• Training and experience in infectious diseases and/or infection control in the hospital setting is preferred.
• Experience with investigational clinical trials is preferred.
• No pharmaceutical industry experience required

 
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Work Location Assignment: On Premise Relocation eligible

Relocation assistance may be available based on business needs and/or eligibility.

Reporting to the Customer Insights Lead, the person in this role will lead a team responsible for all global market research efforts for pipeline oncology assets by providing unbiased, objective, in-depth insights to inform business decisions, including tumor strategies and pivotal go/no-go decisions.

The Director will provide strategic oversight of multiple oncology pipeline assets and is a thought partner to cross-functional leadership teams, including leaders of Commercial Strategy and Innovation, Medical Affairs, Program Leadership, Clinical Development, Global Market Insights, Global Value and Access and others. Through primary and secondary market research and analysis, she/he will provide guidance to her/his team to support the full spectrum of insights and research needs of the organization and works to embed an external market point-of-view into the strategic direction of portfolio oncology pipeline prioritization and planning.

This role is dynamic, fast-paced, highly collaborative, and covers a broad range of strategic topics that are critical to our business. The successful candidate will join Customer Insights colleagues that are constantly helping drive the business through proactive thought leadership, innovative research capabilities, and the ability to communicate complex and dynamic information in new and creative ways.

ROLE RESPONSIBILITIES

Role definition and Key Accountabilities include, but are not limited to:

Market Research

• Lead with a strong understanding of all types of primary market research techniques, both qualitative and quantitative, to fulfill organizational insight needs:

• Formulate business questions, design research to answer them, and collect and assess data.
• Identify implications, develop presentations with clear story lines, integrating new data and existing team knowledge and communicating key insights and recommendations.
• Effectively present insights to various stakeholders.
• Collaborate with other insights and analytics leaders to help synthesize all available information to produce a comprehensive point of view and deliver clear and actionable recommendations
• Experience with oncology secondary data sources (e.g. patient claims, EMR, sales, etc) to triangulate with market research information and inform opportunity assessment

• Support strategic decision making across functional areas.

• Work with across-functional leaders and stakeholders from a wide variety of functions, such as Commercial Strategy and Innovation, Clinical Development, Business Development, Medical Affairs, Research, Therapeutic Area teams, to understand strategic issues.
• Provide a holistic, objective and analytical viewpoint of the market opportunities through ongoing situation analysis and superb understanding of market dynamics, customer and stakeholder needs, and competitive activities.
• Drive strategic thinking and serve as a market insights leader to the US or Global product teams by answering key business questions to define commercial strategies and tactics and drive investment decisions

• Identify informational gaps within the Customer Insights team and cross-functional teams, and plan and coordinate efforts to address those gaps.  Project examples include, but are not limited to, the following:

• Evaluation of target product profiles through qualitative market research with physicians
• Quantitative market research to assess potential product market shares given current and future market dynamics
• Use of syndicated databases to assess market size, treatment patterns, and competitive landscape

• Lead dialogue with local and global analytical teams to adapt global strategies to the local markets.
• Experience and ability to work cross functionally with Legal, Compliance, and Drug Safety to ensure best practices are followed and audit preparedness as necessary.

Team Leadership

• Build, manage, coach a team of direct reports, prioritizing their focus and efforts on an ongoing basis to meet dynamic needs of the large organization, coordinating with internal stakeholders and corporate alliance partners, where applicable
• Contribute to the advancement of Customer Insights capabilities and seek to share knowledge and expertise with other colleagues.
• Lead alignment with other insights analytic functions to ensure cohesive activities with our stakeholders and facilitate best practice sharing.

Vendor/Offshore Resource Management

• Develop, commission and contract innovative complex and impactful research through preferred vendors
• Create and manage budgets associated with assigned activities
• Direct workload of flexible staffing resources and identify the need for changes in flexible resources
• Be accountable for continuous improvement, as well as the identification/ utilization of new capabilities to maximize the competitive advantages of the business
• Accountable for meeting compliance and Corporate SOP obligations of all Primary Market Research projects

REQUIRED BASIC QUALIFICATIONS

• 10+ years of professional experience, with 7+ years in analytics or consulting roles
• Extensive experience and knowledge in quantitative and qualitative market research methodologies
• Understanding of pharmaceutical development and commercialization process, as well as industry competitive dynamics
• Ability to effectively manage multiple competing priorities under ambiguity and uncertainty, and act without having the total picture; outstanding project, budget and vendor management skills, and ability to solve operational problems.
• Demonstrated success defining business information and insight needs and translating those to specific deliverables; understanding of biopharmaceutical commercial market data sources
• Ability to assess and direct vendor technical capabilities and manage risks in the analytic process
• Ability to be flexible, prioritize multiple demands, deal with ambiguity, and lead teams through complex and challenging cross-functional projects
• Strong understanding of legal and regulatory environment in pharmaceutical promotions, and pharma industry guidelines.
• Outstanding interpersonal skills, and excellent verbal and written communication skills.
• Ability to hire and develop direct reports.
• Comfort with senior management and knowledge of senior management though processes; ability to speak their language and address their needs.

PREFERRED QUALIFICATIONS

• Prior managerial experience
• Healthcare and Pharmaceuticals industry experience
• Prior oncology knowledge and experience

OTHER SKILLS

• Strong MS Excel and PowerPoint skills
• Proven ability to act as a strategic partner with the capacity to quickly establish relationships of trust, credibility, and be seen as a driving partner to commercial clients

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

20% Travel Expected

Relocation support available

Work Location Assignment:  North America - Any Pfizer site

ADDITIONAL DETAILS

• Last date to apply for Job: March 23, 2024.

Relocation assistance may be available based on business needs and/or eligibility.

ROLE SUMMARY

Relocation assistance may be available based on business needs and/or eligibility.

ROLE SUMMARY

Relocation assistance may be available based on business needs and/or eligibility.

ROLE SUMMARY

The Oncology Solutions Acct Director (OSAD) is a Customer-Facing colleague and integrated cross-functionally into the KAM Region they support.  The individual in this role will work across a broad, multi-disciplinary group of regional account stakeholders to develop patient-driven solutions, creating opportunities for Pfizer Oncology portfolio products within key accounts across the community, academic and IDN Oncology Service Line segments, with a particular focus on those with scale, resources and orientation toward population health.

The majority of the OSAD’s time will be working directly with customers, KAMs, cKAMs, and Commercial Dx teammates to develop deep customer insights to:

• Advance simple, efficient, & effective execution of population health solutions
• Drive scalability and acceleration of similar engagements at other accounts (across their region and their team into other regions)
• Evolve brand & disease state approach

Specifically, the OSAD in Oncology uniquely must also help take on account management commitments across an Oncology portfolio of unprecedented size that now span more than 15 products and more than 8 therapeutic areas, requiring a division in scope.  While Oncology KAMs retain their role as primary relationship managers of key Oncology accounts for the full portfolio, communicators on oral contracts, and owners of breast cancer (mBC), GU cancer (aPC – CSPC, mUCC) and hematology (multiple myeloma); the OSAD role will be focused in several areas

• Take primary accountability for Lung Cancer, mRCC, mCRPC, and Melanoma
• Advanced precision medicine initiatives
• Innovating in approaches to impacting duration of therapy with accounts (can include supporting breast and bladder efforts)
• Mastering SDoH and health equity space to develop SOC adoption/guideline concordant care opportunities at accounts

The OSAD will have the capacity and capabilities to advance the most innovative engagement with Oncology accounts, but with a focus on the above.  Internal stakeholder collaboration includes, but is not limited to Portfolio Marketing, Advocacy and Prof Relations team, Brand Marketing, HIT Colleagues, KAM leadership, KAM Enablement, Legal, Compliance, Medical, Procurement, and Digital.

ROLE RESPONSIBILITIES

• Accelerate and optimize oncology provider engagement via account-based solutions engagement to drive incremental value for the customer, Pfizer, and the patient
• Work with the Account Collaboration Team (ACT) and organized oncology providers to provide patient driven solutions that support mutually aligned goals for the customer and Pfizer – with a focus on duration of therapy, precision medicine and health equity
• Work with the ACT and the customer in developing an optimal plan for effectively implementing, communicating and improving patient care that is aligned to appropriate goals and KPIs and customers capabilities
• Ensure progress toward customer goals is monitored and plans are adjusted accordingly to ensure impact is established and sustained
• Core insight generation for the Region that informs strategy and optimizes execution and customer engagement
• Identify effective relevant patient management strategies being implemented by Key Accounts that could be spotlighted & replicated at other accounts
• Sharing of best practices across the region on the use of Brand and account management resources that appropriately advances and accelerates customer initiatives
• Act as the voice of the customer and advisory team accountable to the Lung, RCC, CRC, and Melanoma franchises
• Demonstrate Subject Matter Expertise – specifically for
  • Lung, RCC, CRC, and Melanoma
  • Advanced precision medicine engagement and advanced engagement with care teams to improve duration
  • Critical Account Management (project management + change management)
  • Customer organizational governance/decision making/capabilities/stakeholder management 

BASIC QUALIFICATIONS

•  BA/BS Degree
• 10+ years pharmaceutical experience
• 3+ years Oncology key account management experience
• Core capabilities to advance initiatives with sizable accounts to improve patient identification with biomarkers, to improve therapy management and impact duration, and innovate based on unique account-specific opportunities
• Advanced Market experience with Oncology accounts across community / IDN Oncology Service Line / Academic Medical Centers / NCI Affiliated Cancer centers
• Proven ability to develop insights, strategy, operational and tactical plans
• Cross functional / matrix team navigation and management
• Strong persuasive interpersonal, communication and leadership skills
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

PREFERRED QUALIFICATIONS

• Cross-functional team leadership
• Strong strategic analytical capability with sound business acumen and customer orientation
• Strong strategic thinking and analytical skills to synthesize customer and market insights into prioritized opportunities
• Result-oriented with effective planning, prioritization, and project management skills
• Knowledge of the oncology provider landscape and customers
• Effectively works with cross functional stakeholders and is capable of being an effective member of the regional team and ACT 

Other Job Details:

• Last Date to Apply: March 20, 2024

Relocation assistance may be available based on business needs and/or eligibility.

ROLE SUMMARY

The Oncology Solutions Acct Director (OSAD) is a Customer-Facing colleague and integrated cross-functionally into the KAM Region they support.  The individual in this role will work across a broad, multi-disciplinary group of regional account stakeholders to develop patient-driven solutions, creating opportunities for Pfizer Oncology portfolio products within key accounts across the community, academic and IDN Oncology Service Line segments, with a particular focus on those with scale, resources and orientation toward population health.

The majority of the OSAD’s time will be working directly with customers, KAMs, cKAMs, and Commercial Dx teammates to develop deep customer insights to:

• Advance simple, efficient, & effective execution of population health solutions
• Drive scalability and acceleration of similar engagements at other accounts (across their region and their team into other regions)
• Evolve brand & disease state approach

Specifically, the OSAD in Oncology uniquely must also help take on account management commitments across an Oncology portfolio of unprecedented size that now span more than 15 products and more than 8 therapeutic areas, requiring a division in scope.  While Oncology KAMs retain their role as primary relationship managers of key Oncology accounts for the full portfolio, communicators on oral contracts, and owners of breast cancer (mBC), GU cancer (aPC – CSPC, mUCC) and hematology (multiple myeloma); the OSAD role will be focused in several areas

• Take primary accountability for Lung Cancer, mRCC, mCRPC, and Melanoma
• Advanced precision medicine initiatives
• Innovating in approaches to impacting duration of therapy with accounts (can include supporting breast and bladder efforts)
• Mastering SDoH and health equity space to develop SOC adoption/guideline concordant care opportunities at accounts

The OSAD will have the capacity and capabilities to advance the most innovative engagement with Oncology accounts, but with a focus on the above.  Internal stakeholder collaboration includes, but is not limited to Portfolio Marketing, Advocacy and Prof Relations team, Brand Marketing, HIT Colleagues, KAM leadership, KAM Enablement, Legal, Compliance, Medical, Procurement, and Digital.

ROLE RESPONSIBILITIES

• Accelerate and optimize oncology provider engagement via account-based solutions engagement to drive incremental value for the customer, Pfizer, and the patient
• Work with the Account Collaboration Team (ACT) and organized oncology providers to provide patient driven solutions that support mutually aligned goals for the customer and Pfizer – with a focus on duration of therapy, precision medicine and health equity
• Work with the ACT and the customer in developing an optimal plan for effectively implementing, communicating and improving patient care that is aligned to appropriate goals and KPIs and customers capabilities
• Ensure progress toward customer goals is monitored and plans are adjusted accordingly to ensure impact is established and sustained
• Core insight generation for the Region that informs strategy and optimizes execution and customer engagement
• Identify effective relevant patient management strategies being implemented by Key Accounts that could be spotlighted & replicated at other accounts
• Sharing of best practices across the region on the use of Brand and account management resources that appropriately advances and accelerates customer initiatives
• Act as the voice of the customer and advisory team accountable to the Lung, RCC, CRC, and Melanoma franchises
• Demonstrate Subject Matter Expertise – specifically for
  • Lung, RCC, CRC, and Melanoma
  • Advanced precision medicine engagement and advanced engagement with care teams to improve duration
  • Critical Account Management (project management + change management)
  • Customer organizational governance/decision making/capabilities/stakeholder management 

BASIC QUALIFICATIONS

•  BA/BS Degree
• 10+ years pharmaceutical experience
• 3+ years Oncology key account management experience
• Core capabilities to advance initiatives with sizable accounts to improve patient identification with biomarkers, to improve therapy management and impact duration, and innovate based on unique account-specific opportunities
• Advanced Market experience with Oncology accounts across community / IDN Oncology Service Line / Academic Medical Centers / NCI Affiliated Cancer centers
• Proven ability to develop insights, strategy, operational and tactical plans
• Cross functional / matrix team navigation and management
• Strong persuasive interpersonal, communication and leadership skills
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

PREFERRED QUALIFICATIONS

• Cross-functional team leadership
• Strong strategic analytical capability with sound business acumen and customer orientation
• Strong strategic thinking and analytical skills to synthesize customer and market insights into prioritized opportunities
• Result-oriented with effective planning, prioritization, and project management skills
• Knowledge of the oncology provider landscape and customers
• Effectively works with cross functional stakeholders and is capable of being an effective member of the regional team and ACT 

Other Job Details:

• Last Date to Apply: March 20, 2024

Relocation assistance may be available based on business needs and/or eligibility.

ROLE SUMMARY

The Oncology Solutions Acct Director (OSAD) is a Customer-Facing colleague and integrated cross-functionally into the KAM Region they support.  The individual in this role will work across a broad, multi-disciplinary group of regional account stakeholders to develop patient-driven solutions, creating opportunities for Pfizer Oncology portfolio products within key accounts across the community, academic and IDN Oncology Service Line segments, with a particular focus on those with scale, resources and orientation toward population health.

The majority of the OSAD’s time will be working directly with customers, KAMs, cKAMs, and Commercial Dx teammates to develop deep customer insights to:

• Advance simple, efficient, & effective execution of population health solutions
• Drive scalability and acceleration of similar engagements at other accounts (across their region and their team into other regions)
• Evolve brand & disease state approach

Specifically, the OSAD in Oncology uniquely must also help take on account management commitments across an Oncology portfolio of unprecedented size that now span more than 15 products and more than 8 therapeutic areas, requiring a division in scope.  While Oncology KAMs retain their role as primary relationship managers of key Oncology accounts for the full portfolio, communicators on oral contracts, and owners of breast cancer (mBC), GU cancer (aPC – CSPC, mUCC) and hematology (multiple myeloma); the OSAD role will be focused in several areas

• Take primary accountability for Lung Cancer, mRCC, mCRPC, and Melanoma
• Advanced precision medicine initiatives
• Innovating in approaches to impacting duration of therapy with accounts (can include supporting breast and bladder efforts)
• Mastering SDoH and health equity space to develop SOC adoption/guideline concordant care opportunities at accounts

The OSAD will have the capacity and capabilities to advance the most innovative engagement with Oncology accounts, but with a focus on the above.  Internal stakeholder collaboration includes, but is not limited to Portfolio Marketing, Advocacy and Prof Relations team, Brand Marketing, HIT Colleagues, KAM leadership, KAM Enablement, Legal, Compliance, Medical, Procurement, and Digital.

ROLE RESPONSIBILITIES

• Accelerate and optimize oncology provider engagement via account-based solutions engagement to drive incremental value for the customer, Pfizer, and the patient
• Work with the Account Collaboration Team (ACT) and organized oncology providers to provide patient driven solutions that support mutually aligned goals for the customer and Pfizer – with a focus on duration of therapy, precision medicine and health equity
• Work with the ACT and the customer in developing an optimal plan for effectively implementing, communicating and improving patient care that is aligned to appropriate goals and KPIs and customers capabilities
• Ensure progress toward customer goals is monitored and plans are adjusted accordingly to ensure impact is established and sustained
• Core insight generation for the Region that informs strategy and optimizes execution and customer engagement
• Identify effective relevant patient management strategies being implemented by Key Accounts that could be spotlighted & replicated at other accounts
• Sharing of best practices across the region on the use of Brand and account management resources that appropriately advances and accelerates customer initiatives
• Act as the voice of the customer and advisory team accountable to the Lung, RCC, CRC, and Melanoma franchises
• Demonstrate Subject Matter Expertise – specifically for
  • Lung, RCC, CRC, and Melanoma
  • Advanced precision medicine engagement and advanced engagement with care teams to improve duration
  • Critical Account Management (project management + change management)
  • Customer organizational governance/decision making/capabilities/stakeholder management 

BASIC QUALIFICATIONS

•  BA/BS Degree
• 10+ years pharmaceutical experience
• 3+ years Oncology key account management experience
• Core capabilities to advance initiatives with sizable accounts to improve patient identification with biomarkers, to improve therapy management and impact duration, and innovate based on unique account-specific opportunities
• Advanced Market experience with Oncology accounts across community / IDN Oncology Service Line / Academic Medical Centers / NCI Affiliated Cancer centers
• Proven ability to develop insights, strategy, operational and tactical plans
• Cross functional / matrix team navigation and management
• Strong persuasive interpersonal, communication and leadership skills
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

PREFERRED QUALIFICATIONS

• Cross-functional team leadership
• Strong strategic analytical capability with sound business acumen and customer orientation
• Strong strategic thinking and analytical skills to synthesize customer and market insights into prioritized opportunities
• Result-oriented with effective planning, prioritization, and project management skills
• Knowledge of the oncology provider landscape and customers
• Effectively works with cross functional stakeholders and is capable of being an effective member of the regional team and ACT 

Other Job Details:

• Last Date to Apply: March 20, 2024

Relocation assistance may be available based on business needs and/or eligibility.

ROLE SUMMARY

The Oncology Solutions Acct Director (OSAD) is a Customer-Facing colleague and integrated cross-functionally into the KAM Region they support.  The individual in this role will work across a broad, multi-disciplinary group of regional account stakeholders to develop patient-driven solutions, creating opportunities for Pfizer Oncology portfolio products within key accounts across the community, academic and IDN Oncology Service Line segments, with a particular focus on those with scale, resources and orientation toward population health.

The majority of the OSAD’s time will be working directly with customers, KAMs, cKAMs, and Commercial Dx teammates to develop deep customer insights to:

• Advance simple, efficient, & effective execution of population health solutions
• Drive scalability and acceleration of similar engagements at other accounts (across their region and their team into other regions)
• Evolve brand & disease state approach

Specifically, the OSAD in Oncology uniquely must also help take on account management commitments across an Oncology portfolio of unprecedented size that now span more than 15 products and more than 8 therapeutic areas, requiring a division in scope.  While Oncology KAMs retain their role as primary relationship managers of key Oncology accounts for the full portfolio, communicators on oral contracts, and owners of breast cancer (mBC), GU cancer (aPC – CSPC, mUCC) and hematology (multiple myeloma); the OSAD role will be focused in several areas

• Take primary accountability for Lung Cancer, mRCC, mCRPC, and Melanoma
• Advanced precision medicine initiatives
• Innovating in approaches to impacting duration of therapy with accounts (can include supporting breast and bladder efforts)
• Mastering SDoH and health equity space to develop SOC adoption/guideline concordant care opportunities at accounts

The OSAD will have the capacity and capabilities to advance the most innovative engagement with Oncology accounts, but with a focus on the above.  Internal stakeholder collaboration includes, but is not limited to Portfolio Marketing, Advocacy and Prof Relations team, Brand Marketing, HIT Colleagues, KAM leadership, KAM Enablement, Legal, Compliance, Medical, Procurement, and Digital.

ROLE RESPONSIBILITIES

• Accelerate and optimize oncology provider engagement via account-based solutions engagement to drive incremental value for the customer, Pfizer, and the patient
• Work with the Account Collaboration Team (ACT) and organized oncology providers to provide patient driven solutions that support mutually aligned goals for the customer and Pfizer – with a focus on duration of therapy, precision medicine and health equity
• Work with the ACT and the customer in developing an optimal plan for effectively implementing, communicating and improving patient care that is aligned to appropriate goals and KPIs and customers capabilities
• Ensure progress toward customer goals is monitored and plans are adjusted accordingly to ensure impact is established and sustained
• Core insight generation for the Region that informs strategy and optimizes execution and customer engagement
• Identify effective relevant patient management strategies being implemented by Key Accounts that could be spotlighted & replicated at other accounts
• Sharing of best practices across the region on the use of Brand and account management resources that appropriately advances and accelerates customer initiatives
• Act as the voice of the customer and advisory team accountable to the Lung, RCC, CRC, and Melanoma franchises
• Demonstrate Subject Matter Expertise – specifically for
  • Lung, RCC, CRC, and Melanoma
  • Advanced precision medicine engagement and advanced engagement with care teams to improve duration
  • Critical Account Management (project management + change management)
  • Customer organizational governance/decision making/capabilities/stakeholder management 

BASIC QUALIFICATIONS

•  BA/BS Degree
• 10+ years pharmaceutical experience
• 3+ years Oncology key account management experience
• Core capabilities to advance initiatives with sizable accounts to improve patient identification with biomarkers, to improve therapy management and impact duration, and innovate based on unique account-specific opportunities
• Advanced Market experience with Oncology accounts across community / IDN Oncology Service Line / Academic Medical Centers / NCI Affiliated Cancer centers
• Proven ability to develop insights, strategy, operational and tactical plans
• Cross functional / matrix team navigation and management
• Strong persuasive interpersonal, communication and leadership skills
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

PREFERRED QUALIFICATIONS

• Cross-functional team leadership
• Strong strategic analytical capability with sound business acumen and customer orientation
• Strong strategic thinking and analytical skills to synthesize customer and market insights into prioritized opportunities
• Result-oriented with effective planning, prioritization, and project management skills
• Knowledge of the oncology provider landscape and customers
• Effectively works with cross functional stakeholders and is capable of being an effective member of the regional team and ACT 

Other Job Details:

• Last Date to Apply: March 20, 2024

Relocation assistance may be available based on business needs and/or eligibility.

Job Description Summary

Job Description

The Platform & Innovation Lead for Medical Affairs is the voice of Medical Affairs within the Advanced Drug Delivery Systems platform and Innovation teams. Oversees Medical Affairs strategy from preclinical, toxicology to clinical, and human factors, as well as post marketing follow up. The Platform Lead develops a team of core team members for products under development & product life cycle as well as managers.

Responsibilities:

• Sharing clinical expertise, providing input into medical strategy and tactical plans, as well as acting as a sounding board to the emerging questions and challenges from the team
• Accountability of the Medical Affairs strategy for all products under their platform
• Leads development and implementation of the Medical Affairs strategy. Ensure those are aligned with the needs of product development
• Directs and is responsible for evidence generation plans for each respective platform / product and ensures these plans are aligned with the business and market access needs
• Engages with Subject Matter Experts, new customers, and provides scientific support to the platform for managing new opportunities
• Collaborates with Health Economics & Outcome Research, R&D and Marketing to ensure that all evidence generation plans are aligned to the broader evidence generation needs for each respective product and platform
• Creates scientific publication strategy for the platform
• Ensures resources are aligned for executing studies on budget and on time
• Directs and oversees risk management activities for products across the product development workstreams, ensuring medical input is provided throughout each development phase
• Reviews all claims & adProm material related to products within their platform
• Participates in Advanced Drug Delivery Systems LT meetings and represent MA at the New Product Development council and in innovation discussions
• Ensures a total alignment exists between the functional leads and what their team members are doing
• Prioritizes activities within their platform to ensure the workload remains acceptable and negotiates resources with the Platform VP/GM
• Serves as the senior medical leader to the R&D organization, providing medical direction, input and guidance in all platform related R&D and LT forums
• Approves all MA change control responses for products within their platform
• Approves Clinical Evaluation Report for products under their respective platforms and ensures MA aspects of Post Market Surveillance
• Drives innovation under their respective platform
• Provides medical support and input to new product development and R&D innovation workstreams, ensuring all plans and ideas have medical relevance
• Evaluates new product or technology opportunities/concepts, and if supported, develops an evidence pathway, including budget projections, which would be required to ensure market success/product adoption
• Management of safety/medical issues for their respective products

Qualifications:

• MD is requred
• Demonstrated Leadership skills
• Knowledge of either Preclinicals, Toxicology, Clinicals or Human Factors
• Understanding of Design Control and knowledge of combination product regulation
• Customer focused, ability to interact with internal & external customers
• Demonstrated capability for critical thinking, excellent analytical, and problem solving skills
• Ability to integrate medical, scientific, and technical information and effectively communicate the data to customers, internal collaborators, and the Scientific community

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. 

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Primary Work Location

Additional Locations

Work Shift

ROLE SUMMARY

Executive Administrative Lead to Pfizer’s Chief Medical Officer (CMO), Head of Worldwide Medical & Safety, provides administrative and office services of a highly complex and critical nature. The Executive Administrative Lead is expected to be able to work autonomously with exceptional professionalism and attention to detail with work that involves time-sensitive and urgent issues, tight time frames, and in demanding situations. This role will also be expected to think creatively about how we can continue to run the office more efficiently. This role will be a key member of the Office of Pfizer’s CMO.

This position will provide a full range of executive level administrative support to the CMO. The ideal individual will have the ability to exercise good judgment in a diversity of situations, with strong communication, collaboration, administrative, and organizational skills, and the ability to maintain a realistic balance among multiple priorities.

As part of the administrative support team, you are recognized as an advisor to other colleagues in your group due to your comprehensive knowledge and skills in your area and understanding of the larger organization. You are innovative in identifying solutions to problems by taking a broader perspective that benefits the organization. You encourage collaboration and communication within the team and across groups to influence desired outcomes. You train others and provide guidance to the team that helps us achieve our goal of creating breakthroughs that change patients’ lives.

ROLE RESPONSIBILITIES

• Manage sensitive matters with a high level of confidentiality and discretion.
• Monitor CMO’s mailbox including sending and responding to emails on the leader’s behalf, bringing critical/time sensitive matters to immediate attention.
• Manage CMO calendar which includes meeting scheduling, maintaining full year schedule of speaking engagements, conference room reservations, teams meetings, audio/video set-up and associated meeting logistics (i.e., catering, collecting conference agendas and forms, follow-up with conference organizers, etc.)
• Manage complex calendar and anticipate conflicts and use diplomacy to resolve problems in advance.
• Proactively and independently organize and expedite workflow and initiate follow-up when necessary to ensure schedules and deadlines are met.
• Work closely with Chief of Staff on operational planning, updating LT org charts, LT meetings, LT offsites, and other CMO commitments.
• Responsible for all logistics of meetings including conference room reservations, teleconference, videoconference, food ordering and associated meeting logistics.
• Collaborate with Chief of Staff, PX Lead and Communications partners on planning for Town Halls, Extended Leadership Team Meetings, Site Visits and other communication and engagement events.
• Proactively prepare meeting materials in advance
• Prepares registration for conferences and speaking engagements. Provides all information required by conference organizers (bio, photo, speaker form, etc.). 
• Organizes all domestic and international travel for business, including aviation arrangements, hotel accommodations, ground transport, travel documents, visas/passports, and presentation materials for meetings. Prepares detailed itineraries.
• Support logistics and planning of offsites. Research options for meeting venues and cost.
• Prepare expense reports, track reimbursements, and ensure correct AMEX credits/debits; manage purchase orders through Ariba system and tracking invoices.
• Maintain impeccable records and files of CMO documents for auditing purposes.
• Handle the coordination of PE Requests, ensure proper invoice routing and tracking and interfaces with vendors.
• Coordinate and provide key information to other enterprise partners as appropriate.
• Order office supplies and IT equipment as requested.
• Work closely with other Administrative Partners within WMS and across the Pfizer R&D Leadership Team
• Use appropriate discretion in the management of information and stakeholders.

BASIC QUALIFICATIONS

• 5+ years of demonstrated executive administrative assistant experience with 2+ years providing 1:1 executive level support required.
• Ability to carry out all office and administrative functions proficiently, with high quality on a timely basis required.
• Must have the ability and professional demeanor to interface with senior management, international colleagues and important external stakeholders and must be able to exhibit good judgment in handling confidential information.
• Demonstrated resourcefulness with proven ability to anticipate needs, prioritize responsibilities, manage multiple priorities with tight timelines, and take initiative.
• Demonstrated ability to be change agile.
• Demonstrates Pfizer Values.
• Flexible work hours required (early mornings, evenings and/or weekends, as needed).

Required Skills

• Possess excellent communication skills with an ability to respond with professionalism in verbal and written communications with all levels of the organization, including C-Suite.
• Proficiency in MS Word, Excel, PowerPoint, Teams and Outlook are essential.

PREFERRED QUALIFICATIONS

• Associates degree or Bachelor’s degree preferred.
• 10 years administrative assistant experience preferred.
• Bachelor’s degree strongly preferred.
• Strong knowledge of Pfizer headquarters environment.
• Knowledge of Pfizer organizational processes.
• Proficiency in Pfizer systems (e.g., Ariba, SharePoint, Concur, and Workday).
• Knowledge of Pfizer corporate compliance policies, T&E policies, etc.

Relocation assistance may be available based on business needs and/or eligibility.

The Role:

Moderna is seeking a Director of Clinical Operations to manage Oncology programs which may consist of one or more studies. This position will be responsible for initiating and leading clinical programs, inclusive of studies, across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. This position reports to the Executive Director, Clinical Operations, Oncology. This position will work collaboratively across the Oncology and cross-functional teams on the overall development programs and related studies to ensure successful execution of assigned projects.

Here’s What You’ll Do:

• Accountable for delivery of assigned clinical program/studies budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives

• Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan

• Partner and collaborate with cross-functional stakeholders such as the Project Leader, Clinical Development Lead, Regulatory Lead, and other relevant stakeholders

• Lead and oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and Moderna SOPs

• Support the selection, oversight, and management of CROs and other vendors

• Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team

• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate

• Manage and provide oversight to the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations

• Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures.

• Along with other Clinical Development personnel, represent Moderna externally to Investigators, site staff, and Key Opinion Leaders

• Perform and document study level Sponsor Oversight of outsourced clinical activities

• Communicate study-status, cost and issues to ensure timely decision-making by senior management

• Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct

• Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance

• Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives

• Develop and foster strong, collaborative relationships with key stakeholders both within and external to Moderna

• Support program level deliverables/activities

• Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise and support identification and prioritization of study and program level work. May include direct line management of Clinical Operations staff.

• Strive for continuous improvement and more efficient ways of working in clinical development

• Act as a role model for Moderna’s values

Here’s What You’ll Bring to the Table:

• Minimum of BA/BS with at least 10 years of trial and clinical program experience, including 6+ years of high complexity independent, global trial management experience and 2+ years of program-level management Advanced degree preferred.

• Experience in Immuno-Oncology is required. Experience in both solid tumors and hematologic malignancies is desirable. A mixture of early and late stage experience is desirable, some early development experience is required.

• Robust experience in early and late phase drug development

• Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.

• Cross-Collaboration proficiency with other therapeutic areas and functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.

• Experience in GCP inspections/audits

• Outstanding verbal and written communication skills, in addition to excellent organizational skills

• Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry

• Resilient, Creative, capable problem-solver

• Excellent organizational skills and ability to work independently

• Experience in establishing and maintaining relationships with key opinion leaders

• Some travel required

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

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The Role:

Reporting directly to the Senior Director or Executive Director of Medical Writing, this pivotal role carries the significant responsibility of ensuring the delivery of high-quality clinical and regulatory writing. From meticulous planning and coordination to delivering the final drafts, the role demands a keen eye for detail and a robust understanding of the clinical development landscape. This individual will form an integral part of Moderna’s clinical development team, working closely with them to understand and contribute to the broader objectives of Moderna’s clinical development program. This is not just a job, it's an opportunity to drive change and make a difference in the world of biotechnology.

Here’s What You’ll Do:

• Functional Knowledge: Demonstrate a comprehensive understanding of concepts and principles for overseeing the managing medical writing and regulatory writing across multiple clinical development programs.

• Document Planning & Project Management: Oversee the planning, writing, and reviewing of clinical and regulatory documents and responses.

• Cross-Functional Collaboration: Work closely with cross-functional teams to ensure timely delivery of high-quality documents.

• Regulatory Compliance: Ensure all documents comply with regulatory guidelines.

• Data Interpretation: Interpret clinical and statistical data to prepare clear, concise documents.

• Quality Control: Implement and oversee quality control processes for medical writing.

• Document Updates: Manage the updates and revisions of documents as required.

• Problem Solving: Direct the resolution of highly complex or unusual business problems applying advanced critical thinking.

• Impact: Guided by functional plans, impact the quality and timeliness of the functional area and results, and develop area plans.

• Develop and Implement Departmental Strategies: Set goals and objectives for the medical writing team that align with the company's overall strategy.

• Line Management: Oversee and manage the performance of a high-performing medical writing team, providing guidance, feedback, and mentorship. Responsible for hiring, training, and professional development of team members. Ensure resources are allocated effectively and deadlines are met consistently. Foster a collaborative and positive team environment.

Here’s What You’ll Bring to the Table:

• Education: Advanced degree (preferred) with a minimum of 10 years of relevant experience OR bachelors degree with a minimum of 15 years of relevant experience.

• Industry Experience: Proven experience in clinical development, regulatory affairs, or medical affairs.

• Interpersonal Skills: Ability to influence others internally and/or externally, including colleagues in other departments. Some negotiation with limited impact may be required.

• Leadership Skills: Ability to lead dynamically through senior managers or professionals. Translate and execute functional business strategy across multiple related disciplines and contribute to strategic planning for medical writing.

• Business Expertise: Apply market knowledge to drive integrated results across multiple related teams.

• Communication Skills: Excellent written and oral communication skills.

• Quality: Commitment to quality, ensuring that all work produced meets the highest standards of accuracy and comprehensiveness. High attention to detail, organizational skills, and the ability to manage multiple tasks simultaneously.

• Technical Skills: Proficiency in MS Office and familiarity with medical writing software.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

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