Crinetics Pharmaceuticals, Inc. is looking for an Associate Director, Clinical Pharmacology to drive the clinical pharmacology strategy for our pipeline of therapeutics for rare endocrine disorders and endocrine-related cancers. You will lead the design, execution, and interpretation of Phase 1 clinical pharmacology studies and serve as the clinical pharmacology lead on cross-functional project teams.
What You'll Do
- Develop clinical pharmacology strategy and contribute to clinical development plans consistent with target product profiles and regulatory guidance.
- Collaborate with DMPK and clinical research teams to define studies needed to support regulatory submissions and drug labeling.
- Design, plan, and analyze pharmacokinetic and pharmacodynamic studies from Phase 1 through Phase 4.
- Champion model-informed drug development (MIDD) and partner with pharmacometrics to develop population PK and PK/PD models.
- Plan, prepare, and review drug development plans and regulatory filings.
- Provide clinical pharmacology expertise and collaborate closely with Clinical Operations, Clinical Research, Biometrics, and Bioanalysis teams.
- Contribute to the design of specific clinical pharmacology studies, such as drug-drug interaction and bioavailability studies.
- Participate in the selection of Contract Research Organizations (CROs) for Phase 1 studies.
- Be accountable for the analysis and interpretation of PK and PK/PD data.
- Participate in the preparation of clinical study protocols and reports.
- Prepare the clinical pharmacology sections of regulatory documents (IND, IMPD, IB, NDA CTD) and respond to regulatory requests.
- Serve as the primary Clinical Pharmacology Lead on cross-functional teams to integrate modern clinical pharmacology principles.
What We're Looking For
- A Pharm.D./Ph.D. or M.S. in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or a related field with a strong foundation in clinical pharmacology.
- 8+ years of significant industry experience in conducting and overseeing clinical pharmacology studies and data analysis.
- Familiarity with all stages of clinical drug development, including preparing Clinical Pharmacology sections for IND and NDA submissions.
- Proven ability to independently develop clinical pharmacology strategy and design studies to characterize PK and PK/PD relationships.
- Experience preparing INDs, CTAs, NDAs, and MAAs, with a track record of successful regulatory filings.
- Experience working effectively in a cross-functional, matrixed team environment.
- Competence using PK and PK/PD software tools, such as Phoenix.
- Strong written, presentation, and verbal communication skills.
- Demonstrated application of model-informed drug development for strategy and decision-making.
Nice to Have
- Expertise in multiple clinical pharmacology areas, including First-in-Human and Phase II/III dose selection, pediatric dose selection, drug-drug interactions, enzymology of drug metabolism, formulation bridging, bioequivalence, food-effect studies, exposure-QTc assessments, special populations, and radiolabeled mass balance studies.
Technical Stack
- Phoenix for PK and PK/PD analysis.
Team & Environment
You will work in a cross-functional team and matrix environment, collaborating closely with colleagues across disciplines to advance our development programs.
Benefits & Compensation
- Salary range: $166,000 - $208,000
- Discretionary annual target bonus
- Stock options and Employee Stock Purchase Plan (ESPP)
- 401(k) with company match
- Top-tier medical, dental, vision, and basic life insurance for employees and families
- 20 days of PTO
- 10 paid holidays
- Winter company shutdown
Work Mode
This role is onsite in San Diego, California.
Crinetics Pharmaceuticals is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and applicants without regard to sex, sexual orientation, gender identity, pregnancy, race, color, creed, national origin, religion, disability, marital status, age, genetic information, veteran status, or any other protected characteristic under applicable law.
