Associate Director, Clinical Pharmacology at Crinetics Pharmaceuticals

Headquarters, Kentucky, United States -

Full Time

Start Date

Immediate

Expiry Date

30 May, 26

Salary

208000.0

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, Pharmacokinetics, Pharmacodynamics, Model-Informed Drug Development (MIDD), Population PK Models, PK/PD Analysis, Regulatory Filings, Drug-Drug Interactions, Bioequivalence, Special Populations, PK/PD Software Tools, Phoenix Software, IND Preparation, NDA Preparation

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 Associate Director, Clinical Pharmacology will be responsible for 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 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 Job Functions and Responsibilities: These may include but are not limited to: Contribute to 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 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 Champion model-informed drug development (MIDD), and partner with pharmacometrics to develop 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 Research, 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. Be 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.), 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. Other duties as assigned. Education and Experience: Required: Pharm. 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. Demonstrated ability to independently develop clinical pharmacology strategy and 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. 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. Competent in the use of PK and PK/PD software tools such as Phoenix. Strong written, presentation, and verbal communication skills. Demonstrated application of MIDD for development strategy and/or decision-making Physical Demands and Work Environment: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply. Travel: You may be required to travel for up to 5% of your time. 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. Salary Range 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. 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. Thank you for considering Crinetics Pharmaceuticals as your potential employer! Explore job opportunities and discover how you too can make a real impact as we tackle big challenges in endocrinology. Crinetics Pharmaceuticals is a global, clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of the next generation of therapeutics for patients with endocrine and endocrine-rooted diseases. Founded by an innovative team of scientists with a track record of successful drug discovery and development, we’re fueled by collaboration, curiosity, and empathy. We have a prolific discovery engine and robust pipeline across preclinical and clinical development that are purposefully designed to meet the needs of patients, empowering them to live life beyond their condition. Join our team on our mission to improve patients’ lives and transform the treatment paradigm in areas of serious unmet need.

Responsibilities

The Associate Director, Clinical Pharmacology will develop clinical pharmacology strategy, lead the design, execution, interpretation, and reporting of Phase 1 clinical pharmacology studies, and serve as the clinical pharmacology lead on project teams. Responsibilities include contributing to strategy, defining necessary studies, championing Model-Informed Drug Development (MIDD), and preparing regulatory documentation sections.