Senior Director, Clinical Pharmacology at Crinetics Pharmaceuticals

Headquarters, Kentucky, United States -

Full Time

Start Date

Immediate

Expiry Date

30 May, 26

Salary

297000.0

Posted On

01 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Pharmacology Strategy, Clinical Development Plan, Phase 1 Studies, Phase 1-4 Studies, Pharmacokinetics, Pharmacodynamics, Population PK Models, PK/PD Analysis, Drug-Drug Interactions, Thorough QT, CRO Selection, Regulatory Documents, IND, NDA, Project Team Leadership, Mentoring

Industry

Pharmaceutical Manufacturing

Description

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. Position Summary: The Senior Director, Clinical Pharmacology will be a key member of the development team, developing clinical pharmacology strategy suitable for target product profile (TPP) and clinical development plan (CDP), leading the 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. Essential Job Functions and Responsibilities: These may include but are not limited to: 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 (

Responsibilities

The Senior Director will develop clinical pharmacology strategy aligned with the target product profile and lead the design, execution, interpretation, and reporting of Phase 1 clinical pharmacology studies. This role involves serving as the clinical pharmacology lead on project teams, supporting various stages of drug development for small molecule therapeutics.