Key Responsibilities:
- Manage and provide scientific oversight for a small team (4β5 direct reports) of hematology epidemiologists supporting multiple assets/indications; guide planning, design, and execution of epidemiologic studies for clinical development support (safety/effectiveness including post-licensure commitments), endpoint strategy, and observational research methodology.
- Review regulatory documents, study protocols/reports, and publications to ensure scientific integrity and alignment with company strategies.
- Make key epidemiologic decisions; accountable for deliverables (strategies, plans, timelines, reports) and study budgets; executes independently.
- Provide asset-level responsibilities across relevant indications.
- Present plans/results to internal review/governance committees; interact with regulatory agencies/health authorities (FDA, EMA, CDC, WHO).
- Provide epidemiology/regulatory/leadership to set epidemiology strategy; lead planning, conduct, analysis, and reporting of epidemiologic studies.
- Solve problems related to asset development strategy, regulatory strategy, scientific interpretation, and operational/personnel and cross-functional issues.
- Lead people management/mentoring and collaboration; responsible for performance management, recruiting, assignments, resource allocation, development, expense approvals, and coaching.
- Contribute via scientific publications/peer review and participation in external initiatives; may hold academic appointments and supervise PhD/post-doctoral work.
Education/Qualifications:
- Required: MA/MS in Epidemiology with 8 years relevant experience.
- Preferred: PhD in Epidemiology (or related) or MD with additional research training in Epidemiology.
Required Experience/Skills:
- 8+ years relevant experience (preferably pharma/biotech).
- People management experience.
- Experience directing large epidemiologic projects; applied epidemiology in pharma/biotech; peer-reviewed publications.
- Creative problem-solving; excellent oral/written communication; 5% travel.
Preferred:
- Oncology epidemiology experience emphasizing hematology and biomarkers.