Senior Director, Epidemiology

About the role

Under the general direction of the Associate Vice President in Vaccine/Infectious Disease (VID), Epidemiology, the Senior Director, Epidemiology has lead management and oversight responsibility for epidemiologic activities conducted by epidemiologists of their team on assigned products of our Company/indications and provides broad leadership and direction on scientific and operational aspects of epidemiologic research. The primary focus of this position is VID.

Responsibilities

• Has overall responsibility for management and scientific oversight of a team of epidemiologists focusing on Respiratory Disease, as well as Hospital Specialty Medicine therapeutic areas (TAs).
• Makes key epidemiologic decisions and is accountable for deliverables (strategies, plans, timelines, and reports) and for study budgets for the team.
• Solves operational and cross-functional issues (study execution, resourcing, personnel matters, cross-divisional coordination) and ensure deliverables are completed on schedule and within budget.
• Provides expert advice and guidance on the scientific and operational aspects of primary sample and data collection/natural history studies that are unique in Vaccine/Infectious Disease TA to support the clinical programs.
• Leads people management responsibilities: recruit, assign projects, allocate resources, conduct performance management, approve expenses, and provide coaching, mentoring, and professional development for epidemiology staff.
• Maintains and enhances the group’s external scientific reputation by publishing, presenting at conferences, peer-reviewing journals, and participating in academic or consortia activities (teaching, supervising trainees) as appropriate.
• Provides guidance to team members on the overall program-wide epidemiology/real world evidence (RWE) strategy and ensure that the strategy aligns with the program’s clinical, regulatory and HTA strategies.
• Sets epidemiology strategy at the product/indication level, aligning Epidemiology strategy plans and safety/effectiveness evaluations with overall therapeutic area strategy and regulatory requirements.
• Reviews regulatory documents, reports, and scientific publications for assigned TAs to ensure accuracy, consistency, and alignment with company strategy and regulatory expectations.
• Provides expert scientific and regulatory guidance during product development and post-approval phases, including interpreting results, advising on regulatory submissions and responses, and participating in meetings with regulatory agencies, external scientific or industry consortia as needed.
• Track records of identifying opportunities and proposing innovative/advanced methodology to leverage RWE to support clinical development and regulatory decisions.
• Proven ability to build strong, productive relationships with counterparts across clinical development, safety/pharmacovigilance, regulatory affairs, outcomes research, medical affairs, commercial, and external partners.
• Translate epidemiology needs into business terms to obtain resourcing, data access, and operational support from partner functions.
• Identify and cultivate executive sponsors and key opinion leaders network to champion epidemiology initiatives and facilitate escalation when needed.
• Share study findings and methodological rationale in stakeholder forums to anticipate concerns and secure consensus before key decision points.
• Mentor team members on stakeholder management best practices and involve them in cross‑functional meetings to build internal credibility.

Education

• Minimum Requirement: PhD in Epidemiology with 8 or more years of relevant work experience.
• Preferred: PhD in Epidemiology (or related field) or MD degree with additional research training in Epidemiology.

Requirements

• Minimum of 8 years of relevant work experience preferably in the pharmaceutical or biotech industry.
• People management experience.
• Extensive experience in the successful direction of large epidemiologic projects; broad knowledge and experience in the application of epidemiologic approaches to problems in the Pharmaceutical or Biotechnology industry; and record of research publications in peer-reviewed journals.
• Molecular epidemiology training/background.
• Creative problem-solving ability and excellent communication skills (oral and written).

Preferred Experience and Skills

• Experiences in designing and conducting relevant epidemiologic biomarkers/natural history studies and activities.
• Expertise and experiences using innovative/advanced methods to generate RWE supporting clinical development and regulatory decisions.

Required Skills

• Clinical Development
• Data Access
• Data Management
• Epidemiology
• Medical Affairs
• Mentorship
• Methods and Tools
• Natural History
• Organizational Performance Management
• Pharmacovigilance
• Publishing
• Regulatory Affairs Compliance
• Regulatory Requirements
• Researching
• Stakeholder Relationship Management
• Strategic Planning
• Technical Advice

Pay

The salary range for this role is $190,800.00 – $300,300.00. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays, vacation, and compassionate and sick days