Senior Director, ( MD required ) Global Development Lead (Early Stage)
Full-time
Director/C-Level
9 months ago
ROLE SUMMARYSupport clinical trials and the development strategy for early development assets and lead development programs across multiple functions.....
ROLE SUMMARY
- Support clinical trials and the development strategy for early development assets and lead development programs across multiple functions within Pfizer Oncology, as well as represent the program with the external clinical community.
- Develop clinical development plan from first in human clinical trial to proof-of-concept, including assessment of appropriate combinations, as well as evaluation of potential predictive and pharmacodynamics biomarker plans.
- To ensure the clinical components of the clinical plans and clinical expertise are provided to project teams, including medical monitoring of clinical trials.
- To support projects from Research to Proof of Concept at which point molecule may be handed to the late-stage Oncology Clinical Development team for post-POC (typically phase 3) development
ROLE RESPONSIBILITIES
- Lead, develop and execute strategic development for early development assets.
- Oversee early development assets’ development broadly within a specific indication or group of indications. Typically, work on at least two clinical programs and support the development and provide consultation regarding multiple research projects.
- Work across the organization and on multifunctional teams responsible for the development of early development assets (including Product Team).
- Oversee the development and management of clinical protocols and amendments, investigator brochures, clinical study reports, statistical analysis plan, and regulatory documents.
- Provide leadership to early stage clinical scientists on the clinical study team for Early Development Assets, working in a matrix team environment with other clinicians, statisticians, clinical pharmacologists, translational biologists and regulatory specialists. Meet regularly with the Pfizer Oncology group leaders/surrogates across functions to increase mutual awareness and influence of emerging program targets, priorities and status.
- Implementation of PK-guided dose escalation, early combination strategies and emerging innovations on all Pfizer Oncology first-in-human clinical trials with input from Oncology Research Unit, Oncology Regulatory Strategy, Clinical Pharmacology and Precision Medicine, Oncology Clinical Development and Operations, Pharm Sci and Product Teams.
- Oversee the evaluation of safety, pharmacology, and efficacy data from ongoing and completed studies for early development assets.
- Oversee manuscripts, abstracts and presentations for scientific meetings and advisory boards.
- Conduct literature reviews and prepare summaries to support clinical development programs.
- Medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidates.
- Coordinate regular (at least quarterly and as needed) interactions with preferred clinical trials network and KOL advisory board to objectively consider and implement feedback.
- Drive innovations in early clinical development, and the application of translational oncology and precision medicine approaches.
- Collaborates with cross-functional leaders and teams to translate early preclinical discovery research into therapeutic candidates.
- Coordinates with business development to establish strategic external collaborations and foster new research projects and programs.
BASIC QUALIFICATIONS
- MD or MD-PhD with 5-10 years of industry experience in oncology drug development is preferred, track record in early phase drug development.
- Clinical oncology experience: Board certification in oncology preferred.
- Significant industry leadership experience in clinical, translational or basic research in biomedical sciences or one of the disciplines related to drug development.
- Understanding of related disciplines (e.g., biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).
- Demonstrated scientific productivity (publications, abstracts, etc.).
- Proven scientific writing skills and good communication skills.
- Proven leadership skills with ability to defend the clinical plan at governance meetings is essential.
- Capacity to adapt to a fast-paced and changing environment.
- Demonstrated history of effective leadership; including cross functional and matrixed teams, managing direct reports, and experience in seeking and maintaining alignment with cross-functional leaders.
- Demonstrates a passion for helping patients with cancer and for the science of oncology.
PREFERRED QUALIFICATIONS
- Has a strong leadership presence and the ability to work effectively with other clinical and scientific leaders.
- Has a collaborative style with internal company leadership, external development partners and investigators/medical professionals.
- Is a team player, works well in a team environment both as a leader and a key contributor.
- Has a global perspective and mindset, with the ability to work effectively with colleagues from myriad cultures, backgrounds, and geographies
The annual base salary for this position ranges from $253,800.00 to $423,000.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 25.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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