Senior Medical Director, Clinical Research, Endocrinology

Crinetics is a pharmaceutical company based in San Diego, California, developing therapies for endocrine diseases. Position Summary The Senior Medical 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 Clinical leader of one or more endocrinology 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 ( 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. Guide the internal discussions of successive drafts, provide data analyses to guide medical decisions, consult 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 and trend analyses. Provide senior‑level medical monitoring and safety oversight in cooperation with pharmacovigilance, including review of periodic data listings (e.g., adverse events, protocol deviations, concomitant medications). Collaborate with other departments (Biometrics, Clinical Operations, Medical Affairs, a.o.) in all topics related to the conduct and analysis of clinical study results. Guide interpretation of clinical data, use findings and other analyses to contribute to trial‑related advisory boards, lead investigator meetings, protocol training meetings. Support advisory boards, key opinion leader engagement, and external scientific collaborations. 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 finalisation 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 10+ years in biopharmaceutical and/or pharma companies with 5+ years of clinical development spanning across PhaseI–IV trials; a minimum of 10 years in a leadership role with 3‑5 years of people‑management experience; experience from clinical practice in internal medicine/endocrinology; experience in designing, planning and executing First‑in‑Human studies, Phase2 proof‑of‑concept studies and preferably also global Phase3 trials; experience with application of biomarkers; experience interacting with the FDA and/or EU regulatory agencies is a plus; strong general knowledge of GCP, ICH guidelines and regulatory requirements; intimate knowledge of medical monitoring of clinical trials; strong project planning, negotiation and presentation skills; ability to work independently and collaboratively; strategic thinker, team leader and individual contributor; self‑starter with rigorous attention to detail; well‑developed presentation and written communication skills; ethical integrity. Physical Demands and Work Environment On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means; some walking and lifting up to 25lbs may be required; noise level in the work environment is typically low to moderate; reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Travel Up to 5% of the time may be required. Anticipated Base Salary Range $330,000 – $362,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Equal Opportunity Employer Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. #J-18808-Ljbffr