Clinical Development Executive Medical Director, Hematology
Pfizer
9 hours ago
Remote friendly (New York, NY)
United States
Clinical Research and Development
Clinical Development Medical Executive Director (Hematology)
Responsibilities
- Define and execute the development strategy for hematology program(s).
- Lead one or more subteams in clinical development and/or serve as clinical lead across multiple clinical trials.
- Serve as subject matter expert on clinical issues.
- Lead, develop, and execute clinical development plans for one or more hematology indications in alignment with the Lifecycle Management Plan and Integrated Product Plan.
- Endorse clinical decisions in advance of Global Product Team (GPT), senior management reviews, or governance bodies with the Global Development Product Lead (GDPL).
- Provide oversight and management responsibilities for medical director(s) (as applicable).
- Accountable for clinical development strategy, trial design, execution, and delivery of trial results with the GDPL.
- Integrate regulatory, statistical, and internal/external stakeholder input into study designs.
- Serve as primary interface with the Development Review Committee.
- Oversee 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 for optimal dose and schedule selection.
- Own regulatory health authority interactions; escalate to GDPL as needed.
- May participate in evaluating business development opportunities.
- Conduct medical monitoring (eligibility assessment, data review, safety monitoring).
- Lead peer-to-peer interactions with investigators.
- Serve as point of contact for clinical issues between study team, investigators, ethics/steering committees, and regulatory authorities.
- Lead and contribute to development/maintenance of clinical trial and regulatory documents with Clinical Scientist and cross-functional teams.
- Provide clinical development leadership across several study teams.
- Serve as Clinical Development Lead on working groups/subteams, including for Marketing Authorization Applications and business development opportunities.
Strategic Guidance, Clinical Insights & Interpretation
- Lead, develop, and execute strategic development of therapies in designated therapeutic area, collaborating with GDPL as needed.
- Represent the company in external engagements and committee/joint collaborations.
- Collaborate with Clinical Scientist to review and interpret clinical data and communicate key findings to internal/external stakeholders.
- Stay current on developments, literature, and guidelines to drive current and future clinical development plans.
Basic Qualifications
- 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 of medical directors or clinical scientists.
Preferred Qualifications
- 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.
Additional Information
- Global travel may be required.
- Relocation assistance may be available.
- Hybrid role: live within commuting distance; work on-site ~2.5 days/week.
Benefits (as stated)
- Annual base salary: $295,900.00–$478,800.00.
- Eligible for Global Performance Plan bonus target of 30% of base salary and share-based long-term incentive.
- 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
- No specific application instructions provided in the text.
Responsibilities
- Define and execute the development strategy for hematology program(s).
- Lead one or more subteams in clinical development and/or serve as clinical lead across multiple clinical trials.
- Serve as subject matter expert on clinical issues.
- Lead, develop, and execute clinical development plans for one or more hematology indications in alignment with the Lifecycle Management Plan and Integrated Product Plan.
- Endorse clinical decisions in advance of Global Product Team (GPT), senior management reviews, or governance bodies with the Global Development Product Lead (GDPL).
- Provide oversight and management responsibilities for medical director(s) (as applicable).
- Accountable for clinical development strategy, trial design, execution, and delivery of trial results with the GDPL.
- Integrate regulatory, statistical, and internal/external stakeholder input into study designs.
- Serve as primary interface with the Development Review Committee.
- Oversee 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 for optimal dose and schedule selection.
- Own regulatory health authority interactions; escalate to GDPL as needed.
- May participate in evaluating business development opportunities.
- Conduct medical monitoring (eligibility assessment, data review, safety monitoring).
- Lead peer-to-peer interactions with investigators.
- Serve as point of contact for clinical issues between study team, investigators, ethics/steering committees, and regulatory authorities.
- Lead and contribute to development/maintenance of clinical trial and regulatory documents with Clinical Scientist and cross-functional teams.
- Provide clinical development leadership across several study teams.
- Serve as Clinical Development Lead on working groups/subteams, including for Marketing Authorization Applications and business development opportunities.
Strategic Guidance, Clinical Insights & Interpretation
- Lead, develop, and execute strategic development of therapies in designated therapeutic area, collaborating with GDPL as needed.
- Represent the company in external engagements and committee/joint collaborations.
- Collaborate with Clinical Scientist to review and interpret clinical data and communicate key findings to internal/external stakeholders.
- Stay current on developments, literature, and guidelines to drive current and future clinical development plans.
Basic Qualifications
- 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 of medical directors or clinical scientists.
Preferred Qualifications
- 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.
Additional Information
- Global travel may be required.
- Relocation assistance may be available.
- Hybrid role: live within commuting distance; work on-site ~2.5 days/week.
Benefits (as stated)
- Annual base salary: $295,900.00–$478,800.00.
- Eligible for Global Performance Plan bonus target of 30% of base salary and share-based long-term incentive.
- 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
- No specific application instructions provided in the text.