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Crinetics Pharmaceuticals

Discovering drugs for endocrine diseases and endocrine-related tumors. #acromegaly #crinetics #CarcinoidSyndrome

Senior Medical Director

Medical DirectorMedical DirectorOtherRemoteSeniorTeam 201-500Since 2015H1B No SponsorCompany SiteLinkedIn

Location

California

Posted

114 days ago

Salary

$330K - $362K / year

Seniority

Senior

Postgraduate Degree10 yrs expEnglishGCP

Job Description

Senior Medical Director

Crinetics Pharmaceuticals

• 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

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