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Crinetics Pharmaceuticals

Medical Director, Clinical Research, Endocrinology

RemoteUnited States only
Published
Experience
Senior
Employment
Full-time
Company size
Mid-size
$270k–$298k/yr
Check eligibility

Open to US only. Set where you work from to check your eligibility.

No BS summary

Senior physician (MD) with 5+ years clinical research experience in industry or academia to lead endocrinology clinical development (Phase 1–3). Must have deep knowledge of clinical monitoring, FDA/EMA regulations and GCP; endocrine subspecialty board certification preferred. Remote role supporting Crinetics (San Diego-based employer).

Core skills

Medical monitoringClinical development plan (CCDP)

Required skills

Clinical trial designMedical monitoring of clinical trialsGood Clinical Practice (GCP)ICH guidelinesFDA regulationsEMA regulationsMedical writing (clinical sections)Clinical pharmacologyBiostatistics familiarity

Optional skills

Endocrinology subspecialty board certificationExperience with HEOR/Patient Reported Outcome researchExperience interacting with regulatory agencies (FDA and/or EU)Experience leading advisory boards and investigator meetings

What you'll do

  • Partner with cross-functional teams to shape and maintain a concise Clinical Development Plan (CCDP) for indications of interest.
  • Contribute to Strategic Plans and the Target Product Profile (TPP) via multidisciplinary consultation.
  • Lead design, planning and implementation of clinical trials consistent with the CCDP.
  • Provide scientific and clinical direction for clinical protocols, CTOs, synopses, amendments, and related documents (e.g., informed consent) in collaboration with Medical Writing.
  • Provide medical monitoring for clinical studies in collaboration with CRO medical monitors.
  • Ensure clinical trials are conducted according to GCP and applicable regulatory requirements.
  • Provide clinical and scientific input to HEOR-led Patient Reported Outcome research.
  • Provide oversight to support enrollment feasibility and protocol-driven eligibility.
  • Participate in data analyses and review for Clinical Study Report (CSR) completion and filing activities.
  • Contribute to clinical sections of regulatory documents (Investigators' Brochures, briefing books, IND/BLA submissions, safety updates).
  • Lead trial-related advisory boards, investigator meetings, and protocol training meetings.
  • Collaborate with Medical Affairs and Commercial to develop relationships with investigators, KOLs and patient advocates.
  • Provide medical/clinical expertise to publications planning and drafting.
  • Oversee clinical programs across planning, execution, and completion ensuring compliance with regulations, ICH/GCP, and SOPs.
  • Attend conferences and remain current with therapeutic area information.
  • Serve as the external clinical face of Crinetics in interactions with partners and at advisory boards.
  • Other duties as assigned.

What they require

  • MD degree with at least 5+ years clinical research experience within industry or academia.
  • Endocrinology subspecialty board certification preferred.
  • Thorough knowledge of clinical medicine, clinical pharmacology and associated disciplines (e.g., biostatistics, data management, medical writing).
  • Deep understanding of strategic and operational aspects of clinical research and product development.
  • Solid understanding of FDA and EMA regulations and expectations, Good Clinical Practice, and ICH guidelines.
  • Familiarity with regulatory agency interactions (FDA and/or EU).
  • High-level expertise in day-to-day medical monitoring of clinical trials (eligibility questions, safety review, SAE processing and narratives).
  • Excellent leadership skills and ability to function in a fast-paced, high-accountability environment.
  • Superior interpersonal, collaboration, influencing and presentation skills.
  • Ability to conceive and execute innovative clinical development approaches while considering patient safety and comfort.
  • Rigorous attention to detail and data while maintaining strategic perspective.

Benefits

  • Discretionary annual target bonus
  • Stock options
  • ESPP
  • 401k match
  • Health insurance (medical, dental, vision) and basic life insurance
  • 20 days of PTO
  • 10 paid holidays
  • Winter company shutdown
  • Dog-friendly workplace (company culture)

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors.

🇺🇸 United StatesPharmaceuticalsMid-sizecrinetics.com/
$270k–$298k/yr