Sr. Director, Epidemiology - Hematology
Merck
11 hours ago
Remote friendly (Boston, MA)
United States
Clinical Research and Development
Under the general direction of the AVP, Epidemiology, the Senior Director, Epidemiology leads management and oversight of epidemiologic activities conducted by the epidemiologists on assigned company assets and indications. Primary focus: hematology.
Key responsibilities:
- Manage and provide scientific oversight for a small team of hematology epidemiologists supporting multiple assets/indications; guide planning, design, and execution of epidemiologic studies/activities 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 team study budgets; executes independently.
- Own asset-level responsibilities across relevant indications.
- Present research plans/results to internal review/governance committees; interact with regulatory agencies/health authorities (e.g., FDA, EMA, CDC, WHO).
- Provide epidemiology strategy for assets/indications; lead planning, conduct, analysis, and reporting of epidemiologic studies.
- Solve operational/scientific/regulatory problems, including cross-functional and personnel matters.
- People management: performance management, recruiting, expense approval, project assignments, resource allocation, employee development, coaching/mentorship.
- Maintain expert recognition; may publish/present and serve as peer reviewer.
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.
- Minimum 8 years relevant experience (preferably pharma/biotech); people management experience; extensive experience directing large epidemiologic projects; record of peer-reviewed publications.
- Strong problem-solving and oral/written communication; 5% travel.
- Preferred: oncology epidemiology experience with emphasis on hematology and biomarkers.
Required skills: Biopharmaceuticals, Biopharmaceutics, Clinical Development, Data Management, Endocrinology, Epidemiology, Executive Oversight, Hematology, Human Resource Management, Methods and Tools, Multitasking, Pathophysiology, People Management, Regulatory Compliance, Researching, Stakeholder Relationship Management, Strategic Planning, Technical Advice.
Travel: 5%.
Key responsibilities:
- Manage and provide scientific oversight for a small team of hematology epidemiologists supporting multiple assets/indications; guide planning, design, and execution of epidemiologic studies/activities 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 team study budgets; executes independently.
- Own asset-level responsibilities across relevant indications.
- Present research plans/results to internal review/governance committees; interact with regulatory agencies/health authorities (e.g., FDA, EMA, CDC, WHO).
- Provide epidemiology strategy for assets/indications; lead planning, conduct, analysis, and reporting of epidemiologic studies.
- Solve operational/scientific/regulatory problems, including cross-functional and personnel matters.
- People management: performance management, recruiting, expense approval, project assignments, resource allocation, employee development, coaching/mentorship.
- Maintain expert recognition; may publish/present and serve as peer reviewer.
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.
- Minimum 8 years relevant experience (preferably pharma/biotech); people management experience; extensive experience directing large epidemiologic projects; record of peer-reviewed publications.
- Strong problem-solving and oral/written communication; 5% travel.
- Preferred: oncology epidemiology experience with emphasis on hematology and biomarkers.
Required skills: Biopharmaceuticals, Biopharmaceutics, Clinical Development, Data Management, Endocrinology, Epidemiology, Executive Oversight, Hematology, Human Resource Management, Methods and Tools, Multitasking, Pathophysiology, People Management, Regulatory Compliance, Researching, Stakeholder Relationship Management, Strategic Planning, Technical Advice.
Travel: 5%.