Crinetics Pharmaceuticals, Inc. is seeking a Senior Medical Director, Clinical Research to lead the strategy and execution of clinical development for our endocrinology compounds. In this hands-on role, you will be accountable for designing, executing, and analyzing clinical trials, playing a key part in interpreting results and preparing summary documents for global regulatory submissions.
What You'll Do
- Serve as the clinical leader for one or more endocrinology programs, integral to developing clinical strategy and plans.
- Participate as a member of global project teams and development sub teams.
- Contribute as the Clinical Research expert to the conception and modifications of the Target Product Profile (TPP).
- Lead the development of the Clinical Development Plan (CDP) for each indication.
- Conceive and write the Clinical Study Outline for each study in the CDP.
- Lead discussions and oversee writing of study synopsis, protocol, and amendments.
- Review or oversee review of data input in the EDC for events of interest and all reports from ongoing studies.
- Provide senior-level medical monitoring and safety oversight in cooperation with pharmacovigilance.
- Collaborate with other departments on topics related to the conduct and analysis of clinical study results.
- Support advisory boards, key opinion leader engagement, and external scientific collaborations.
- Contribute to the development of relevant sections of regulatory documents and preparation for regulatory interactions.
- Contribute to the preparation of clinical sections of NDA and MAA and lead drafting of responses to regulatory questions.
- Provide leadership, career management, and personal development to direct reports.
What We're Looking For
- MD degree.
- 10+ years of experience in biopharmaceutical and/or pharmaceutical companies.
- 5+ years of clinical development experience spanning across Phase I–IV trials.
- A minimum of 10 years in a leadership role.
- 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 and Phase 2 proof-of-concept studies.
- Experience with the application of biomarkers.
- Strong general knowledge of GCP, ICH guidelines, and regulatory requirements.
- Intimate knowledge of day-to-day medical monitoring of clinical trials.
- Excellent leadership skills and ability to function in a fast-paced, high accountability environment.
- Strong project planning, negotiation, and presentation skills.
- Ability to work independently and collaboratively, prioritizing tasks efficiently.
- Strategic thinker, team leader, and individual contributor.
- Able to prioritize and parallel process multiple workstreams.
- Self-starter with rigorous attention to details and data.
- Able to conceive and execute innovative approaches to clinical development.
- Well-developed presentation and written communication skills.
- Ethical, with the highest standards of integrity.
Nice to Have
- Experience with global phase 3 trials.
- Experience interacting with the FDA and/or EU regulatory agencies.
Team & Environment
You will be a member of global project team(s) and development sub team(s), embedded in a patient-centric, team-oriented, and inclusive workplace culture. Crinetics is a dog-friendly workplace.
Benefits & Compensation
- Compensation range: $330,000 - $362,000
- Discretionary annual target bonus
- Stock options
- ESPP
- 401k match
- Top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
- 20 days of PTO
- 10 paid holidays
- Winter company shutdown
Work Mode
This role is onsite in San Diego, California.
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.
