Vice President, Drug Safety/Pharmacovigilance

Role Summary

The Vice President of Drug Safety/Pharmacovigilance will design and lead the global Drug Safety and Pharmacovigilance system, ensuring resourcing, compliant safety reporting, and risk management across Crinetics’ products. The role provides safety oversight of clinical programs, supports regulatory submissions, and drives safety strategy from development through post-approval activities.

Responsibilities

• Safety reporting processes.
• Ensure the accurate receipt and processing of safety assessment reports.
• Ensure that medical and causality assessments of all clinical and post-marketing adverse event filings to regulatory authorities are consistent with company policies as well as regulatory requirements.
• Review and ensure the completeness and accuracy of safety assessment of aggregated reports as required by regulatory agencies.
• Provide safety support to Clinical Research.
• Oversee the preparation of new drug application safety updates and investigational new drug safety reports.
• Oversee the development and preparation of safety reports for company management as well as external regulatory agencies.
• Manage, coordinate, and provide ongoing assessment, evaluation, and communication with other Crinetics departments and external vendors (CRO, consultants, etc.) to ensure study safety objectives are accomplished.
• Together with Clinical Research, provide drug safety oversight of clinical programs including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Crinetics SOPs.
• Review clinical data from all phases of development and assist in generating study reports and publications.
• Accountable for safety content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions, and responses, and other program documents.
• Accountable for Safety Surveillance Systems.
• Develop and oversee safety surveillance systems for Crinetics drug candidates and products.
• Partner with Clinical Sciences to ensure appropriate drug safety techniques and principles are applied across all stages of development.
• Provide medical safety expertise to publications planning.
• Accountable for Risk Management Activities.
• Partner with Clinical Research when investigations into special safety issues are required, including development of white papers as needed.
• Accountable for the development of appropriate pre- and post-approval safety surveillance plans.
• Provide coaching and mentoring to direct and indirect reports.
• Develop and implement strategic plans and objectives for the department in alignment with corporate strategy.
• Develop and implement SOPs for regulatory reporting, safety surveillance and related activities as required.
• Support the CMO with oversight and management of the department budget and financial planning.
• Other duties as assigned.
• Focus on short-term (<2 years) and medium-term (3-4 years) strategy.

Qualifications

• MD with a minimum of 13 years of drug safety/PV experience in the biotechnology/pharmaceutical drug industry and a minimum of 14 years in a supervisory role.
• Excellent leadership skills and ability to function effectively in a fast-paced, high accountability environment.
• Strong project planning, leadership, negotiation, and presentation skills as well as an ability to contribute creative yet practical solutions to problems.
• Ability to work independently and collaboratively, prioritizing tasks efficiently and meeting clinical and corporate timelines.
• Thorough knowledge of clinical medicine, clinical pharmacology, and associated disciplines (e.g., biostatistics, data management, medical writing).
• Strong general knowledge of GCP, ICH guidelines and regulatory requirements that apply to clinical drug development.
• Experience in interacting with the FDA and/or EU regulatory agencies.
• Thorough understanding of strategic and operational aspects of clinical research and product development.
• Superior interpersonal skills focusing on collaboration and influencing capabilities.
• Provide coaching and mentoring to direct and indirect reports.
• Focus on short- and mid-term strategic planning and the development of department objectives aligned with corporate strategy.
• Develop and implement SOPs for regulatory reporting, safety surveillance and related activities as required.
• Support the CMO with oversight and management of the department budget and financial planning.
• Other duties as assigned.

Additional Requirements

• Travel up to 20% of your time.
• Physical demands: ability to sit at a desk for long periods; intermittent phone use and keyboard work; some walking and lifting up to 25 lbs; laboratory/environmental considerations may apply.