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 (<2 years) strategic planning horizon.
- 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.
- 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 the 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 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.
Requirements
- 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 the focus on experience in bridging between discovery/research into the clinic.
- Experience with application of biomarkers.
- 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.
Nice to Have
- Experience interacting with the FDA and/or EU regulatory agencies is a plus.
Benefits
- 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
- a winter company shutdown
Work Arrangement
On-site
Team
Structure: multi-disciplinary team
Additional Information
- You may be required to travel for up to 5% of your time.
- 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 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
