Director of Pharmacoepidemiology / Directress of Pharmacoepidemiology

Director, Pharmacoepidemiology - Contract - Remote, USA

Are you a leader in pharmacoepidemiology 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, working remotely within the United States.

Primary Responsibilities

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.

Skills & Requirements

• 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.
• A minimum of a Bachelor's degree with relevant industry experience in biotech or pharma.

Key Responsibilities

• 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.

To apply for this exciting opportunity, please use the form below. Only applications matching the job profile will be considered.

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