Design and develop the Global Crinetics Drug Safety and Pharmacovigilance system
Ensure adequate resourcing, efficient and compliant safety reporting
Implement Safety Surveillance Programs
Oversee the safety profiles of Crinetics products
Play a leading role in safety risk management activities
Provide safety support to Clinical Research
Oversee the preparation of new drug application safety updates and investigational new drug safety reports
Manage, coordinate, and provide ongoing assessment, evaluation, and communication with other Crinetics departments and external vendors
Ensure study safety objectives are accomplished
Review clinical data from all phases of development and assist in generating study reports and publications
Develop and oversee safety surveillance systems for Crinetics drug candidates and products
Provide coaching and mentoring to direct and indirect reports.

MD with a minimum of 13 years of drug safety/PV experience in the biotechnology/pharmaceutical drug industry
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.

Discretionary annual target bonus
Stock options
ESPP
401k match
Top-notch health insurance plans for employees and their families (medical, dental, vision, basic life insurance)
20 days of PTO
10 paid holidays
Winter company shutdown

Vice President, Drug Safety/Pharmacovigilance

Key skills