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Clinical Development Executive Medical Director, Hematology

Pfizer
4 months ago
Remote friendly (Cambridge, MA)
United States
$295,900 - $478,800 USD yearly
Clinical Research and Development
Clinical Development Medical Executive Director (Hematology)

Responsibilities
- Define and execute hematology program(s) development strategy; collaborate with the Global Development Product Lead (GDPL)
- Lead product-specific Global Development Team (may) and serve as clinical subject matter expert
- Lead, develop, and execute clinical development plan for one or more hematology indications aligned with the Lifecycle Management Plan and Integrated Product Plan
- Endorse clinical decisions in advance of GPT, senior management reviews, or governance bodies with the GDPL
- Provide oversight/management for medical director(s) (may)
- Accountable for clinical development strategy, trial design, execution, and delivery of trial results with the GDPL
- Integrate regulatory, statistical, and stakeholder input into study designs
- Serve as primary interface with the Development Review Committee
- Oversee development/management of clinical protocols and amendments, investigator brochures, and clinical study reports
- Oversee evaluation, interpretation, reporting, and presentation of study data
- Own clinical safety evaluations and safety decisions; escalate to GDPL as needed
- Own clinical pharmacology input for optimal dose and schedule selection
- Own regulatory input for health authority interactions; escalate to GDPL as needed
- Conduct medical monitoring (eligibility assessment, data review, safety monitoring)
- Lead peer-to-peer interactions with investigators; serve as point of contact between study teams, investigators, ethics/steering committees, and regulatory authorities
- Lead and contribute to clinical trial and regulatory document development/maintenance (with Clinical Scientist and cross-functional team)
- Provide clinical development leadership across multiple study teams
- Serve as Clinical Development Lead on working groups/subteams (incl. Marketing Authorization Applications) and in business development opportunities (may)
- Represent company in external engagements/joint collaborations

Strategic Guidance & Clinical Insights
- Lead, develop, and execute therapy strategic development in designated therapeutic area, collaborating with GDPL as needed
- Collaborate with Clinical Scientist to review/interpret clinical data, identify key findings/implications, and communicate to internal/external stakeholders
- Stay current with latest literature, developments, and guidelines to advise and drive current/future clinical plans

Qualifications
Required (Basic)
- Medical degree or advanced degree with relevant clinical/industry experience (typically 4+ years)
- 7+ years industry experience
- 5+ years experience leading diverse teams
- Prior management responsibilities for medical directors or clinical scientists

Preferred
- Board certified/eligible in oncology (or equivalent)
- Experience across multiple phases of clinical development and across drug classes in oncology
- Experience leading NDA, BLA, or MAA

Work Model / Other
- Global travel may be required
- Relocation assistance may be available
- Hybrid role: live within commuting distance; work on-site ~2.5 days/week

Benefits / Compensation
- Annual base salary range: $295,900.00–$478,800.00
- Eligible for Global Performance Plan bonus target of 30% of base salary; eligible for share-based long-term incentive program
- 401(k) with matching contributions and additional retirement savings contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; health benefits (medical, prescription drug, dental, vision)

Application instructions
- If you need assistance with accessibility of the website/application/interviewing, email disabilityrecruitment@pfizer.com.