Crinetics Pharmaceuticals

Crinetics Pharmaceuticals

Associate Director, Clinical Pharmacology

Remote, USA · Director

Sponsorship not specified$166k-$208kDetected 91 days ago
Clinical TrialsClinical ResearchPharmacologyResearchAnimal StudiesCommunicationPublic Speaking

About the role

  • 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 Job Functions and Responsibilities:
  • These may include but are not limited to:

Responsibilities

  • Collaborate with DMPK and clinical research 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
  • 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, etc.)
  • Prepare clinical pharmacology section of the regulatory documents (IND, IMPD, IB, NDA CTD, etc.), respond to regulatory requests for information (RFIs), and 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.

Nice to have

  • D./Ph.D. or MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, Engineering or related field with a strong understanding of clinical pharmacology principles.
  • 8+ years of 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.
  • Expertise/experience in multiple clinical pharmacology areas is preferred
  • 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.
  • Demonstrated application of MIDD for development strategy and/or decision-making

Skills

  • Competent in the use of PK and PK/PD software tools such as Phoenix.
  • Strong written, presentation, and verbal communication skills.

Compensation

  • The salary range for this position is: $166,000 - $208,000.
  • In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match.

Benefits

  • Environmental health and safety requirements also apply.
  • 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.

Company info

  • Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors.
  • We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives.
  • Our work continues to make a real difference in the lives of patients.
  • We have a prolific discovery engine and a robust preclinical and clinical development pipeline.
  • We are driven by science with a patient-centric and team-oriented culture.
  • Crinetics is known for its inclusive workplace culture.
  • We are also a dog-friendly workplace.
  • This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients.
  • Join our team as we transform the lives of others.

Equal opportunity

  • Employer:
  • Crinetics is proud to be 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.
  • Crinetics is proud to be 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.

Visa & Work Authorization

  • tation, 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 s
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This listing is sourced directly from Crinetics Pharmaceuticals's careers page and normalized into a canonical job model.