Senior Director, Clinical Pharmacology Lead

4 weeks ago

San Diego, California, United States Crinetics Pharmaceuticals Full time
Senior Director, Clinical Pharmacology

Crinetics Pharmaceuticals is seeking a highly experienced Senior Director, Clinical Pharmacology to join our team. As a key member of our development team, you will be responsible for developing clinical pharmacology strategy and leading the design, execution, interpretation, and reporting of Phase 1 clinical pharmacology studies.

Key Responsibilities:

  • Develop clinical pharmacology strategy and related clinical development plan consistent with the target product profile, program goals, and regulatory guidance.
  • Collaborate with DMPK, clinical research, and CMC teams to define biopharmaceutics and clinical pharmacology studies needed to support an NDA and drug label.
  • Determine scope, design, plan, and analyze phase 1-4 pharmacokinetic and pharmacodynamics studies, including development of appropriate population PK models, and PK/PD analysis required from a development and regulatory perspective.
  • Provide clinical pharmacology expertise to the project team and closely collaborate with Clinical Operations, Clinical Research, Biometrics, and Bioanalysis.
  • Contribute to the design Phase 1 clinical pharmacology studies, including drug-drug interactions, relative bioavailability/bioequivalence, special populations, and thorough QT studies.
  • Participate in the selection of Phase 1 CROs for clinical pharmacology studies.
  • Accountable and responsible for the analysis and interpretation of PK and PK/PD data.
  • Participate in preparation of clinical study protocol and report.
  • Plan, prepare, and review clinical pharmacology section of the regulatory documents (IND, IMPD, IB, NDA CTD, etc.), participate in drafting publications and making scientific presentations consistent with development strategies.
  • Serve as the primary Clinical Pharmacology Lead and effectively participate in cross-functional teams to ensure integration of modern clinical pharmacology principles into project plans and study design.
  • Represent clinical pharmacology at regulatory meetings and advisory hearings with global health authorities as a subject matter expert.
  • Foster a culture of innovation, collaboration, and continuous learning within the team.

Requirements:

  • Pharm. D./Ph.D. or MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with a strong understanding of clinical pharmacology principles.
  • 13+ years of significant industry experience in conduct and/or oversight of clinical pharmacology function, studies, and data analysis, and a minimum of 10 years of experience in a supervisory role.
  • Familiarity with all stages of clinical drug development, including prior experience in the preparation of components of the Clinical Pharmacology sections of Regulatory submissions for IND- and NDA-stage projects.
  • Demonstrated ability to independently develop clinical pharmacology strategy and design studies to characterize PK and PK/PD relationships of clinical development compounds.
  • Expertise/experience in multiple clinical pharmacology areas is preferred - FIH and/or Ph II/III dose selection, pediatric dose selection, drug-drug interactions, enzymology of drug metabolism, formulation bridging, bioequivalence, food-effect, exposure-QTc assessments, special population, and radiolabeled mass balance studies.
  • Extensive experiences in preparation of INDs, CTAs, NDAs, and MAAs as well as successful results from the filings.
  • Experience in working in a cross-functional team/matrix environment with strong vendor management skills.
  • Competent in the use of PK and PK/PD Modeling software tools such as Phoenix.
  • Strong written, presentation, and verbal communication skills.
  • Critical thinker with strong problem-solving skills.
  • Ability to influence business leaders at all levels.

What We Offer:

  • Competitive salary range: $230,000 - $288,000.
  • 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.

Crinetics Pharmaceuticals is 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.

Vaccination Requirement:

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

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