Responsibilities:
- Lead management and scientific oversight of a small team of hematology epidemiologists (4β5 direct reports) supporting multiple assets/indications.
- Guide epidemiologic study planning, design, execution for clinical development support; safety/effectiveness (incl. post-licensure commitments); endpoint strategy; observational research methodology.
- Review regulatory documents, study protocols/reports, and publications for scientific integrity and alignment with company strategies.
- Make key epidemiologic decisions; accountable for deliverables (strategies, plans, timelines, reports) and team study budgets.
- Present epidemiologic research plans/results to internal review/governance committees; interact with regulatory agencies/health authorities (e.g., FDA, EMA, CDC, WHO).
- Provide leadership on epidemiology strategy for assets/indications; independently lead planning, conduct, analysis, and reporting of epidemiologic studies.
- Deliver problem-solving across asset development strategy, regulatory strategy, scientific interpretation, and operational/personnel/cross-functional issues.
- Manage/mentor team performance (resource allocation, recruiting, project assignments, coaching/employee development).
- Contribute via publications, conference participation/presentations, and peer review; may join external initiatives and academic activities.
Qualifications:
- Required: MA/MS in Epidemiology + 8 years relevant experience.
- Preferred: PhD (Epidemiology/related) or MD with additional epidemiology research training.
- Minimum 8 years relevant experience (preferably pharma/biotech); people management experience.
- Extensive experience directing large epidemiologic projects; knowledge applying epidemiologic methods in pharma/biotech; peer-reviewed publications.
- Creative problem-solving; excellent oral/written communication.
Preferred:
- Training/experience leading oncology epidemiologic studies focused on hematology and biomarkers.