Senior Medical Director, Pharmacovigilance

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.

Position Summary:

The incumbent will be responsible for global pharmacovigilance for the Company’s investigational and/or marketed products assigned to them, including review and analysis of safety data, providing medical expertise to assigned project teams, the identification and investigation of safety signals, management of benefit-risk profile for assigned products and review of aggregate reports. Responsible for keeping upper management informed of safety issues.

This is a critical role to ensure the safety of patients taking Crinetics investigational and marketed products. May be assigned work of a more complex nature or a global product that is marketed with risk management programs.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Maintains expert knowledge of safety, including any emerging safety concerns and risk/benefit profile for responsible compounds.

• Focus on immediate and short-term (<2 years) strategic planning horizon. May have input on medium-term strategic planning.

• Responsible for review of Individual Case Safety Reports (ICSRs). Ensures completeness and accuracy of safety information in ICSR through assessment of seriousness, expectedness, causality, MedDRA coding, review of narrative summary, and providing case comments; provide medical inquiries for follow-up.

• Participates in individual project teams and provides medical input/expertise. 

• Responsible for safety signal detection activities for assigned products and discuss safety signals as needed, at the Safety Review Team (SRT).

• Chairs the SRT for responsible products and works effectively with all cross-functional stakeholders (internal and external) to discuss and manages all new emerging safety signals from clinical trials and post-marketing environment. 

• Responsible for contributing and review of aggregate reports (DSUR, PSUR, RMP, ad-hoc safety reports) including but not limited to providing expert medical opinion. Drafts the appropriate safety sections, as well as Risk/benefit sections for aggregate safety reports.

• Support the development and execution of risk management strategies and author internal risk tracking plans and risk management/pharmacovigilance plans for submission to global health authorities for assigned products.

• Provides medical opinion and safety input to inquiries from regulatory authorities, IRBs, ethics committees, etc.

• Establishes good communication and foster relationships with cross-boundary stakeholders including PV Vendors, and Crinetics Partners on all pharmacovigilance-related issues.

• Responsible for the maintenance and updating of benefit-risk profile for assigned products through product lifecycle.

• Contributes and reviews safety sections of study reports, protocols, informed consents, Company Core Data Sheets, Investigator Brochures, clinical summary of the NDA/MAA and product labeling.

• Contributes to the strategy for NDA/MAA filing. Lead or contributes to the components of NDA/MAA dossier.

• Attends cross-functional or project-specific team meetings to provide medical expertise, as needed.

• Provide leadership, career management, and personal development to direct reports.

• Performs other tasks and assignments as needed and specified by management

Education and Experience:

Required:

• MD or DO Degree is required; experience with endocrinology or rare disease products is a plus, but not required.

• A minimum of 7-12 years of Pharmaceutical Industry experience within the Drug Safety Department is required and 13 years total relevant experience.

• A minimum of 10 years in a leadership/supervisory role.

• Global drug safety experience including