Senior Medical Director

Role Summary

The Senior Medical Director, Clinical Research will work within a multidisciplinary team and be accountable for developing the strategy and Clinical Development Plan for one or more indications for a Crinetics compound. The role involves hands-on design, execution, and analysis of clinical trials, and shaping the interpretation of results, as well as preparing summary documents for global regulatory submissions.

Responsibilities

• Clinical leader of one or more endocrinology programs, developing the clinical strategy and plans.
• Member of global project teams and development sub-teams; focus on immediate and short-term (<2 years) strategic planning horizon.
• Contribute as the Clinical Research expert to conception and regular modifications of the Target Product Profile (TPP).
• Lead the development of the Clinical Development Plan (CDP) for each indication, using the TPP as guidance, coordinating cross-functional collaborations throughout the asset life cycle.
• Conceive and write the Clinical Study Outline for each study in the CDP.
• Lead discussions and oversee the writing of the study synopsis, study protocol and amendments; guide internal discussions, provide data analyses to guide medical decisions, and consult with external Medical Experts and Regulatory authorities.
• Review or oversee data input in the EDC for events of interest or needing further investigation and all reports from ongoing clinical studies, including trend analyses.
• Provide senior-level medical monitoring and safety oversight in cooperation with pharmacovigilance; review listings (adverse events, protocol deviations, concomitant medications); collaborate with Biometrics, Clinical Operations, Medical Affairs, and other departments; guide interpretation of clinical data and contribute to trial-related advisory boards and investigator meetings.
• Support advisory boards, key opinion leader engagement, and external scientific collaborations.
• Contribute to regulatory documents (protocol amendments, briefing books, safety updates) and collaborate with Regulatory Affairs in regulatory interactions; contribute significantly to NDA/MAA clinical sections and timely drafting of responses to regulatory questions.
• Provide leadership, career management and development to direct reports.
• Other duties as assigned to meet business needs.

Qualifications

• MD degree with 10+ years in biopharmaceutical and/or pharma companies with 5+ years of clinical development spanning across Phase I–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, Phase 2 proof-of-concept studies and preferably also global phase 3 trials, with focus on bridging between discovery/research into the clinic.
• 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 and trial design that apply to clinical drug development.
• Intimate knowledge of and high-level expertise in the day-to-day medical monitoring of clinical trials required (e.g., responding to questions about patient eligibility; review of safety parameters; receiving and processing SAEs, drafting of SAE narratives) including the application of biostatistics, data management, medical writing.
• Excellent leadership skills and ability to function effectively in a fast-paced, high accountability environment.
• Strong project planning, 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.
• Strategic thinker, team leader and individual contributor capable of working in a high growth, dynamic, science-driven environment.
• Able to prioritize and parallel process multiple workstreams, comfortable "changing gears" and remaining flexible, as well as making definitive decisions.
• Self-starter, who enjoys rolling up their sleeves and digging into the details; rigorous attention to details and data, while not losing sight of the bigger picture.
• Able to conceive and execute innovative approaches to clinical development.
• Ability to inspire and earn respect of the leadership team, Board members, the investment community, colleagues, and staff. Respectful of the ideas and experience of all members of the Crinetics team.
• Well-developed presentation and written communication skills; effective at board level, as well as with the scientific/medical community, advisers, and colleagues.
• Ethical, with highest standards of integrity recognizing that we are the creators of hope for our patients and the health care professionals who serve them as well as stewards of the investments of all our shareholders.

Education

• MD degree with 10+ years in biopharmaceutical and/or pharma companies with 5+ years of clinical development spanning across Phase I–IV trials.

Additional Requirements

• Travel: Up to 5% of time may be required.
• Physical Demands: On a continuous basis, sit at a desk for long periods; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs may be required. The 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 and responsibilities.