Senior Medical Director, Clinical Research

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 Senior Director, Clinical Research will be working within a multi-disciplinary team and will be accountable for developing the strategy and the Clinical Development Plan for one or more indications for a specific Crinetics' compound.  The incumbent will have hands-on responsibility designing, executing, and analyzing clinical trials. The incumbent will have a key role in the understanding and interpretation of the results from these studies as well as the preparation of the summary documents needed for a global submission to regulatory authorities.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Clinical leader of one or more oncology programs, being integral to developing the clinical strategy and plans.
• Member of global project team(s) and development sub team(s).
• Focus on immediate and short-term (<2 years) strategic planning horizon.
• Develop department processes to achieve department and corporate objectives.
• Contribute as the Clinical Research expert to the conception and regular modifications of the Target Product Profile (TPP).
• Lead the development of the Clinical Development Plan (CDP) for each indication being pursued, using the TPP as a guidance; this includes coordinating cross-functional collaborations with other departments as needed throughout the asset life cycle.
• Conceive and write the Clinical Study Outline for each study in the CDP.
• Lead the discussions and oversee the writing of the study synopsis, study protocol and its amendments. This entails guiding the internal discussions of the successive drafts, providing data analyses to guide medical decisions, consulting with external Medical Experts and Regulatory authorities.
• Review or oversee the review on a regular basis the data input in the EDC for events of interest or needing further investigation and all reports generated from ongoing clinical studies (see next bullet also) and trend analyses.
• Prepare, in cooperation with biometrics and pharmacovigilance, periodic data listings (e.g. adverse events, protocol deviations, concomitant medications) and review these for discussion with clinical team.
• Collaborate with other departments (Biometrics, Clinical Operations, Medical Affairs, a.o.) in all topics related to the conduct and analysis of clinical study results. Use the findings and other analyses to contribute to trial-related advisory boards, lead investigator meetings, protocol training meetings.
• Contribute to the development of relevant sections of regulatory documents such as amendments to protocols, briefing books, safety updates, responses to Health Authorities questions and collaborate with Regulatory Affairs in the preparation of regulatory interactions.
• Contribute significantly to the preparation, drafting and finalization of all the clinical sections of NDA and MAA. Lead the timely drafting of responses to questions from regulatory authorities.
• Provide leadership, career management and personal development to direct reports.
• Other duties as assigned to meet business needs.

Education and Experience:

Required:

• MD degree with at least 10 years' overall experience with 8 years in clinical development within biopharmaceutical and/or pharma companies spanning across translational medicine and/or late-stage development.
• A minimum of 10 years in a leadership role, leadership in a cross functional environment would be sufficient.
• Experience from clinical practice in internal medicine and/or pediatrics is preferred.
• Experience in designing, planning, and executing First-in-Human studies, Phase 2 proof-of concept studies and preferably also global phase 3 trials- with the focus on experience in bridging between discovery/research into the clinic.
• Experience with application of biomarkers.
• Experience interacting with the