Job description
POSITION SUMMARY:
Crinetics Pharmaceuticals is seeking an experienced senior clinical pharmacologist to join its growing and dynamic development team. This individual will be responsible for design, execution, interpretation, and reporting of Phase 1 clinical pharmacology studies, and serve as clinical pharmacology lead on studies and project teams. The work will support projects at various stages of development thereby allowing the selected candidate to play an active role in our drug discovery and development efforts to advance small molecule therapeutics for rare endocrine disorders and endocrine-related cancers.
This is a unique opportunity to work with a proven and well-funded drug discovery and development team in a small company environment in the heart of San Diego’s biotechnology community.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
- Lead the design Phase 1 clinical pharmacology studies (eg, drug-drug interactions, relative bioavailability/bioequivalence, special populations, etc.)
- Serve as the primary Clinical Pharmacology Lead and effectively participate in cross functional teams to present data and ensure integration of clinical pharmacology principles into project plans and study design
- Contribute to clinical pharmacology strategy as part of the overall clinical development plan consistent with the program goals and the US and international regulatory guidance/guideline of small molecule therapeutics
- Provide clinical pharmacology support to the project team and closely collaborate with Toxicologists, Pharmacometricians, Clinical Operations, Clinical Research, Biometrics, and Bioanalysis for preclinical and clinical studies
- Participate in the selection of Phase 1 CROs for clinical pharmacology studies
- Perform and be accountable for non-compartmental analysis and interpretation of PK data
- Work with Clinical Research, Biostatistics and Regulatory colleagues to participate in late phase clinical protocol development to ensure appropriate assessment of Clinical Pharmacology endpoints
- Participate in preparation of clinical study protocol and report
- Prepare 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
- Other duties as assigned
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
- Pharm. D./Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with 8 years of experience, or BS/MS degree in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with 10 years of experience, or equivalent education and experience
- Position will be filled at level commensurate with experience
- Strong understanding of clinical pharmacology principles and significant industry experience in conduct and/or oversight of clinical pharmacology studies and data analysis
- 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 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
- Experience in working in a cross functional team and matrix environment
- Competent in the use of PK and PK/PD Modeling software tools such as Phoenix
- Strong written, presentation and verbal communication skills
- Prior experience in population PK and exposure-response analysis using Phoenix NLME, NONMEM, R/S-Plus or related software is a plus but not required
TECHNICAL KNOWLEDGE REQUIRED:
Equipment: PC, scanners, voice mail and e-mail systems, and common office machines, or ability to be trained
Software Knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint), Phoenix WinNonlin. Knowledge of other software recommended: GraphPad Prism
TRAVEL:
Travel may be required up to 5% of your time
THE ANTICIPATED BASE SALARY RANGE: $165,000 - $184,000
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide 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, and a winter company shutdown in December.
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.
ABOUT CRINETICS:
Crinetics Pharmaceuticals Inc. (www.crinetics.com) is a rare endocrine and endocrine-related cancer therapeutics company. Crinetics’ benefit package includes health insurance, stock options, a 401k, paid time off, and the company provides a dog-friendly work environment.
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