Associate Director, Medical Information

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:

Crinetics is seeking an Associate Director of Medical Information to act as a medical information specialist in our developing Medical Affairs department. This role is critical for the accurate and timely dissemination of medical information as Crinetics approaches FDA-approval of several products and considers global commercialization of an exciting pipeline. This position interacts with internal stakeholders such as clinical research, sales & marketing, regulatory, and research teams to obtain necessary updated information of both investigational and marketed products, and to inform other stakeholders of new issues that may arise. You will provide guidance and direction pertaining to the receipt, processing, and dissemination of safety information and ensure dissemination of medical information meets regulatory guidelines and follows Crinetics SOPs. This is a fun and inspiring time at Crinetics, and we welcome those who can joyfully handle the excitement and continuous improvement that comes with launching new products.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Learn the science of complicated disease states and detailed data of research projects across multiple products to be the “go-to” person for internal and external questions about the science.
• Participate in the maintenance and continuous improvement of a product knowledge database that is easily accessible to answer external inquiries proficiently
• Create and maintain accurate and fair-balanced standard response letters (SRL) and custom responses to unsolicited external medical information requests
• Prepare, along with other internal teams, for multiple product launches in succession, including managing med info responsibilities of investigational products and applying the unique compliance guidelines that accompany the pre-approval period.
• Manage high-performing partners and vendors, such as a call center, to support compliant responses to unsolicited requests for medical information, as well as intake and triage of AE and PQC case reports in conjunction with the Pharmacovigilance Team
• Provide guidance on the receipt, processing, and dissemination of safety information and ensure all safety information is handled in compliance with regulatory guidelines and internal protocols
• Establish, track, and report KPIs for inquiry volume, turn-around times, and customer satisfaction
• Participate in the MLR review process for internal and external medical and commercial materials
• Coordinate medical and scientific congress activities with other company departments and provide in-person medical information support, including booth-related activities and materials
• Collaborate with Clinical Research, Sales & Marketing, Regulatory, and other internal experts to obtain necessary product information and updates
• Inform internal stakeholders of new issues or developments that may impact product knowledge or medical information dissemination
• Participate in the preparation and submission of reports to regulatory agencies and help ensure all reports are accurate, comprehensive, and submitted within required timelines
• Ensure the dissemination of medical information co