Director, Pharmacometrics

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Director, Pharmacometrics

Apply remote type Remote locations Remote time type Full time posted on Posted Yesterday job requisition id JR000275

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 Director of Pharmacometrics will use quantitative clinical pharmacology approaches to answer important clinical questions and support model-informed drug development decisions. Multiple programs, interesting challenges, and strong cross-functional collaborators will allow the individual to make a substantial impact and enhance their career development. The work will support projects at various stages of development thereby allowing the individual 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:

• Contribute to pharmacometrics 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 project team members and partner CROs to conduct appropriate pharmacometric analyses (population PK, PK-PD, exposure-response, PBPK, simulations, etc.) to answer development questions
  • Work within program teams to understand and anticipate the quantitative needs of each project
  • Contribute to efficient clinical study designs with respect to PK and PD
  • Assist in formulation of program- and study-level analysis plans
  • Hands-on use of modeling and simulation tools to understand complex PK, PK/PD, and exposure-response data
  • Interpret analysis results, generating actionable conclusions and new hypotheses
  • Communicate model-informed interpretations and advice to project teams
• Participate in preparation of pharmacometrics-related sections of various regulatory documents (INDs, NDAs, IBs, etc.).
• Determine department/function objectives and assign tasks, goals, and development of direct reports and other team members.
• Develop departmental processes to achieve department and corporate objectives
• Other duties as assigned

Education and Experience:

Required:

• Pharm.D/Ph.D. or MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with a strong understanding of clinical pharmacology principles.
• Significant industry experience (Director: MS and 10+ years of experience) in clinical pharmacology data analysis and interpretation.
• Extensive experience in population PK and exposure-response analysis using Phoenix NLME, NONMEM, Pumas or related software and requisite programming skills in SAS, R, or similar.
• Familiarity with all stages of clinical drug development, including experience in the preparation of components of the Clinical Pharmacology sections of Regulatory submissions for IND- and NDA-stage projects.
• Experience working in a cross functional team and matrix environment.
• Strong written, presentation and verbal communication skills.
• Ability to influence business leaders at all levels.
• Critical thinker with strong problem-solving skills.
• Demonstrated leadership, strategic thinking, collaboration, and management skills to oversee and develop in-house pharmacometrics capabilities.

Preferred:

• Experience with PBPK modeling, QSP modeling, and/or integration of AI/ML into clinical pharmacology 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.

Travel:

You may be required to travel for up to 5% of your time.

The Anticipated Base Salary Range: $195,000 - $232,000

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.