Note: The job is a remote job and is open to candidates in USA. Crinetics Pharmaceuticals is a pharmaceutical company based in San Diego, California, developing therapies for endocrine diseases and related tumors. The Senior Director, Clinical Pharmacology will lead clinical pharmacology strategy, oversee Phase 1 studies, and collaborate with various teams to advance small molecule therapeutics.
Responsibilities
- Develop clinical pharmacology strategy and related clinical development plan consistent with the target product profile, program goals, and the US/international regulatory guidance/guideline of small molecule therapeutics
- 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 to take a project from its existing or concept stage to commercialization
- 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 (eg, drug-drug interactions, relative bioavailability/bioequivalence, special populations, and thorough QT, etc.)
- 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 insure 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
- Focus on both immediate/short-term (<2 Years) and long range (5 years) strategic planning to determine function objectives
- Lead, direct, manage, develop, coach/mentor, and evaluate direct reports, contributing to budget and headcount planning
- Other duties as assigned
Skills
- Pharm. D./Ph.D. or MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with a strong understanding of clinical pharmacology principles
- 10+ 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. 13 years of overall professional experience is required
- 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 experience 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
- Prior experience in population PK and exposure-response analysis is a plus but not required
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
- Winter company shutdown
Company Overview