Position Summary The Vice President of Drug Safety/Pharmacovigilance will be instrumental in supporting the growth of the organization as the company continues to build the value of its current products and develop new products. The incumbent will design and develop the global drug safety and pharmacovigilance system, ensuring adequate resourcing, efficient and compliant safety reporting, implementation of safety surveillance programs, oversight of safety profiles and play a leading role in safety risk management activities. Essential Responsibilities Develop and implement safety reporting processes and ensure the accurate receipt and processing of safety assessment reports. Perform medical and causality assessments of all clinical and post‑marketing adverse event filings to regulatory authorities, ensuring consistency with company policies and regulatory requirements. Review and ensure the completeness and accuracy of safety assessments of aggregated reports 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 and external regulatory agencies. Coordinate with internal departments and external vendors (CROs, consultants) to achieve study safety objectives. Provide drug safety oversight of clinical programs, including planning, execution, and completion of clinical trials in accordance with ICH/GCP, Crinetics SOPs. Review clinical data from all phases of development, assist in generating study reports and publications, and be accountable for safety content of protocols, investigator brochures, clinical study reports, regulatory submissions, and responses. Develop and oversee safety surveillance systems for Crinetics drug candidates and products. Partner with Clinical Sciences to apply appropriate drug safety techniques and principles across all development stages. Provide medical safety expertise for publication planning. Lead risk management activities, including investigations into special safety issues and development of white papers. Develop appropriate pre‑ and post‑approval safety surveillance plans. Coaching and mentoring of direct and indirect reports. Focus on short‑term ( Education and Experience MD with a minimum of 13 years of drug safety/pharmacovigilance experience in the biotechnology/pharmaceutical drug industry. Minimum of 14 years in a supervisory role. Excellent leadership skills, strong project planning, negotiation and presentation skills. Experience with FDA and/or EU regulatory agencies. Strong knowledge of GCP, ICH guidelines, regulatory requirements, clinical medicine, clinical pharmacology, biostatistics, data management, medical writing. Superior interpersonal skills with collaborative and influencing capabilities. Physical Demands and Work Environment On a continuous basis, sit at a desk for a long period of time, intermittently answer telephone calls and use a keyboard. Some walking and lifting up to 25 lbs. may be required. The noise level is typically low to moderate. Reasonable accommodations can be made to enable individuals with disabilities to perform essential functions. Travel Requirements Up to 20% travel may be required. Compensation and Benefits Anticipated base salary range: $339,000 – $424,000 per year. In addition, total rewards include a discretionary annual target bonus, stock options, Employee Stock Purchase Program (ESPP), and 401(k) match. Health insurance plans cover medical, dental, vision, basic life insurance. Paid time off: 20 days of PTO, 10 paid holidays, and a winter company shutdown. Equal Opportunity Employer Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and applicants without regard to sex, sexual orientation, gender identity or expression, pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion, disability, marital or civil union status, age, genetic information, veteran status, or any other protected characteristic. #J-18808-Ljbffr