Crinetics Pharmaceuticals
Discovering drugs for endocrine diseases and endocrine-related tumors. #acromegaly #crinetics #CarcinoidSyndrome
Senior Medical Director
Location
California
Posted
5 days ago
Salary
$330K - $362K / year
Postgraduate Degree10 yrs expEnglishGoogle Cloud Platform
Job Description
• 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
• 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
• 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
• Provide senior‑level medical monitoring and safety oversight in cooperation with pharmacovigilance
• 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
Job 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
- 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
- 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
- Self-starter, who enjoys rolling up their sleeves and digging into the details
- 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.
Benefits
- 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
- discretionary annual target bonus
- stock options
- ESPP
- 401k match
