Clinical Development Executive Medical Director, Hematology

Clinical Development Medical Executive Director (Hematology)

Responsibilities:
- Define and execute the hematology development strategy for one or more programs; lead/develop/execute clinical development plans aligned with Lifecycle Management Plan and Integrated Product Plan
- Lead product-specific Global Development Teams; oversee and provide clinical development leadership across several study teams; may lead one or more subteams in clinical development
- Serve as subject matter expert on clinical issues; endorse clinical decisions in advance of GPT, senior management reviews, or governance bodies
- Accountable for clinical development strategy, trial design, execution, and delivery of trial results with the Global Development Product Lead (GDPL)
- Integrate regulatory, statistical, and other internal/external stakeholder input into study designs
- Serve as primary interface with the Development Review Committee; oversee clinical protocols/amendments, investigator brochures, and clinical study reports
- Oversee evaluation, interpretation, reporting, and presentation of study data
- Accountable for safety decisions and clinical evaluations; escalate to GDPL as necessary
- Accountable for clinical pharmacology input on optimal dose and schedule selection
- Accountable for regulatory interactions with health authorities; escalate to GDPL as necessary
- Lead peer-to-peer interactions with investigators; serve as point of contact for clinical issues among study team, investigators, ethics committees, steering committees, and regulatory authorities
- Lead and contribute to development/maintenance of clinical trial and regulatory documents in collaboration with the Clinical Scientist and cross-functional team
- Participate in evaluating business development opportunities; serve as Clinical Development Lead on working groups/subteams (e.g., for Marketing Authorization Applications)
- Conduct medical monitoring (eligibility assessment, data review, safety monitoring)

Strategic Guidance, Clinical Insights & Interpretation:
- Lead, develop, and execute strategic development of therapies in designated therapeutic area in collaboration with GDPL as needed
- Represent the company in external engagements/joint collaborations
- Collaborate with Clinical Scientist to review/interpret clinical data, identify key findings, communicate implications to internal/external stakeholders
- Maintain clinical expertise by staying current with literature and guidelines to advise on current/future clinical development plans

Required Qualifications (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 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 in leading NDA, BLA, or MAA

Work Details:
- Global travel may be required
- Hybrid role: live within commuting distance and work on-site ~2.5 days per week
- Relocation assistance may be available (based on business needs/eligibility)

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