Senior Director, Clinical Pharmacology

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 (<2 Years) and long range (5 years) strategic planning to determine function objectives.

Lead, direct, manage, develop, coach/mentor, and evaluate direct reports, contributing to budget and headcount planning.

Other duties as assigned.

Required

Education and Experience:

• Pharm. D./Ph.D. or MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with a strong understanding of clinical pharmacology principles.
• 13+ years of significant industry experience in conduct and/or oversight of clinical pharmacology function, studies, and data analysis, and a minimum of 10 years of experience in a supervisory role.
• 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.
• Extensive 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 with strong vendor management skills.
• Competent in the use of PK and PK/PD Modeling software tools such as Phoenix.
• Strong written, presentation, and verbal communication skills.
• Critical thinker with strong problem-solving skills.
• Ability to influence business leaders at all levels.
  
  

Preferred

• Prior experience in population PK and exposure-response analysis is a plus but not required.
  
  

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.

The Anticipated Base Salary Range: $230,000 - $288,000

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.

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.

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.

Vaccination Requirement

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.