Vice President, Clinical Pharmacology

Crinetics is a pharmaceutical company based in San Diego, California that develops much-needed therapies for people with rare endocrine diseases. 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 robust pipeline across preclinical and clinical development. We are driven by science with a patient-centric and team-oriented culture. 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. Come join our team as we transform the lives of others.

Position Summary

The Vice-President, clinical pharmacology is responsible for strategic contributions to both drug discovery and development projects. Working in collaboration with colleagues in Discovery, DMPK, Toxicology, CMC, Regulatory, Clinical Operations, and Clinical Development, he/she will lead the Clinical Pharmacology department and provide scientific leadership in study design, data interpretation, and aid in global harmonization of study execution and reporting. He/she will build and lead a team of clinical pharmacologists and bioanalysis professions in achieving team, department, and corporate goals.

Essential Job Functions And Responsibilities

These may include but are not limited to:

• Develop strategic plans to continue building of the clinical pharmacology department
• Hire, coach, and develop clinical pharmacology staff
• Lead long range planning, annual budgeting, and reforecast activities for clinical pharmacology department
• Develop strategy and provide high level guidance to executive management and program team on clinical pharmacology, bioanalysis for drug and biomarkers, and pharmacometrics for all Crinetics’ drug development programs
• Oversee all strategic planning aspects of nonclinical and clinical bioanalysis/biomarker analysis, clinical pharmacology, and modeling/simulation in support of development programs
• Oversee team in Identifying, proposing timing and design for clinical pharmacology studies (e.g., rBA/BE, DDI, special population, human ADME, and TQT etc.) needed to support clinical development and NDA submissions, and collaborate with clinical operations to oversee, contract, and manage clinical pharmacology studies
• Implement efficient and effective modeling and simulation strategy, including population PK, exposure-response analysis, and physiologically based PK (PBPK) to support clinical trial design, justification of dosing regimen, and provide supportive evidence of efficacy and safety for regulatory submissions
• Oversee authoring of relevant sections/modules of regulatory dossier (including INDs, IBs, CTAs, IMPDs, NDAs, briefing packages, or other regulatory dossier)
• Attend and participate in meetings with FDA and ex-US regulatory authorities
• Be conversant with bioanalysis and clinical pharmacology guidances, relevant literature and methodologies, and mitigate areas of risk
• Oversee team in the analysis of data, including internally or externally contracted PK/PD data analysis and advanced modeling and simulation, from nonclinical and clinical studies
• Participate in development of program timelines as clinical pharmacology expert to ensure proper integration of functional activities into overall plan
• Monitor, communicate and manage budgets and long-range planning for their functional area.
• Oversee departmental processes and infrastructure such as SOP’s, operational support, templates, etc.
• Responsible for vendor and qualification activities in compliance with Crinetics’ SOPs and GXPs
• Set clear outcomes/goals/deliverables for functional areas and projects with accountability to the company management team
• Develop relationships with external parties (e.g., CROs, consultants, KOLs, QA, and regulatory professionals) and stay current on industry trends and practices
• Provide guidance and train staff members as necessary. Provide regular feedback and coaching for their professional development
• Other duties as assigned
  
  

Required

Education and Experience:

These May Include But Are Not Limited To

• PhD or MS in biological/pharmaceutical sciences or related discipline with at least 15 years of experience in a biotech/life science, pharmaceutical or related industry (an equivalent combination of experience and education may be considered)
• Extensive experience in drug development functions (e.g., Nonclinical and Clinical) is required
• A minimum of 14 years of experience managing an internal team, external service providers (worldwide), and consultants is required
• Hands-on experience with clinical PK and PK/PD data analysis required (e.g., Phoenix WinNonlin); expertise with advanced modeling and simulation (e.g., Population PK, PBPK) strongly preferred.
• Prior experience leading all aspects of clinical pharmacology for small molecule program at various stages, including design and/or analysis of clinical pharmacology studies, pivotal trial design, Health Authority interactions, NDA/MAA filings, label negotiations, approval, and commercialization
• Excellent writing skills and familiar with ICH/FDA/EMA guidance/guideline as they relate to clinical pharmacology and preparation of regulatory documents, such as IND/CTA filings and/or NDA/MAA/PMDA submissions
• Excellent interpersonal skills with strong oral/written communication and presentation skills
• Excellent negotiation skills and a tactful approach that leads to high value on outcomes achieved
• Excellent command of applicable GxPs
• Leadership and management skills, and, demonstrated qualities in this area
• Demonstration of cross-functional understanding related to drug development
• Good judge of risks and Excellent problem-solving ability to analyze options and manage outcomes
• Well versed with the latest trends in the drug development industry
  
  

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 10% 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

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.

Total Compensation

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.

Salary Range

The salary range for this position is: $307,000 - $384,000.