Director Pharmacoepidemiology

Director, Pharmacoepidemiology- Contract - Remote, US

Are you a pharmacoepidemiology leader looking to shape evidence-generation strategies that influence drug development, regulatory decisions, and patient safety on a global scale?

Proclinical is seeking a Director of Pharmacoepidemiology to join a dynamic team remotely within the US.

The successful candidate will lead the development and implementation of pharmacoepidemiology strategies within the designated therapeutic area. You will collaborate with cross-functional teams to support regulatory filings, clinical development, and post-marketing commitments. This position requires expertise in epidemiologic methods and the ability to provide strategic insights to influence decision-making processes.

• Strong collaboration and results-oriented mindset with the ability to build consensus across teams.
• Proven experience in the drug development process and navigating matrix organizations.
• Ability to manage multiple tasks and projects with urgency and strategic focus.
• Excellent verbal and written communication skills, including presentation abilities.
• Demonstrated business and financial acumen with a track record of process improvement.
• Resilient and innovative, with the ability to explore alternative solutions to achieve outcomes.
• Minimum of a Bachelor's degree with relevant industry experience in biotech or pharma.

• Develop and implement pharmacoepidemiology strategies, including real-world evidence generation and regulatory agency-required studies.
• Lead activities such as post-marketing commitments (e.g., PASS, PAES, PMR, DUS) and evaluate the effectiveness of REMS and RMMs.
• Contribute to risk management plans, benefit-risk analyses, signal management, and responses to regulatory queries.
• Collaborate with Global Patient Safety, Clinical Scientists, Regulatory Affairs, and other functions to design, implement, and analyze epidemiological studies.
• Explore external databases (e.g., claims, EMR, surveys, registries) to address safety-benefit questions and support clinical development.
• Represent Pharmacoepidemiology on cross-functional teams, including Safety Monitoring Teams and Clinical Study Teams.
• Drive non-compound-specific activities such as literature reviews and database queries for regulatory filings.
• Participate in the development and maintenance of SOPs, working instructions, and process improvement initiatives.
• Manage contractors and external vendors as needed.
• Build and maintain professional relationships with external experts to ensure high-quality evidence generation.