About this role

Responsible for oversight and delivery of the strategic integrated evidence generation plans (IEGPs) across therapeutic areas for pipeline and marketed medicines
Oversee design and implementation of Medical Affairs-led real-world evidence (RWE), epidemiological studies, HEOR, patient preference, and non-interventional studies
Guide development of phase IIIb/IV trials, registries, and observational studies
Ensure quality and timely delivery of study protocols, statistical analysis plans, and reports
Anticipate evidence gaps and proactively adjust tactical plans to serve the data needs of key stakeholders, including Regulatory authorities, HTAs, HCPs, and payers
Ensure all activities comply with GCP, regulatory standards, and internal policies
Manage budgets, timelines, and vendor relationships
Monitor and report on the impact of evidence generation activities

Advanced degree (MS/PhD/PharmD)
Minimum of 12 years in pharmaceutical/biopharmaceutical industry inclusive of Medical Affairs
8+ years’ experience in research related experience and/or pharmaceutical industry experience
Experience with late-stage clinical studies, research collaborations and RWE
Proven track record of strong leadership, project management and demonstrated ability to coach and mentor individuals
Strong Regulatory and medical information communications knowledge and experience
Experience building and leading cross-functional teams in a global matrix organization

Senior Director, Medical Evidence Generation

Key skills