Director, Clinical Pharmacology – Remote

Categories: Clinical Pharmacology
POSITION SUMMARY:
 
Crinetics Pharmaceuticals is seeking an experienced Clinical Pharmacologist to join its growing and dynamic development team. This individual will be a key member of the development team, developing the clinical pharmacology strategy and 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. (Position will be filled at level commensurate with experience.)
 
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
 
These may include but are not limited to:
 
  • Contribute to clinical pharmacology strategy and related clinical development plan consistent with the program goals and the US and international regulatory guidance/guideline of small molecule therapeutics.
  • Collaborate with DMPK and Medical Science 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.
  • Plan, prepare, and review drug development plans and regulatory filings.
  • Provide clinical pharmacology expertise to the project team and closely collaborate with Clinical Operations, Clinical Sciences, Biometrics, and Bioanalysis.
  • Contribute to the design Phase 1 clinical pharmacology studies (eg, drug-drug interactions, relative bioavailability/bioequivalence, special populations, 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.
  • 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.
  • 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.
 
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
 
  • Pharm. D./Ph.D. or MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with a strong understanding of clinical pharmacology principles.
  • Ph.D. with 8+ years experience, MS/BS Degree with minimum 12 years of experience. Significant industry experience in conduct and/or oversight of clinical pharmacology studies and data analysis preferred.  
  • 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 with requisite programming skills 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 10% of your time.
 
ABOUT CRINETICS:
 
Crinetics Pharmaceuticals Inc. (www.crinetics.com) is a rare endocrine disease and endocrine-related cancer therapeutics company. Crinetics’ benefits package includes health insurance, stock options, ESPP, a 401k, paid time off, and the company provides a dog-friendly work environment.