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

Education and Experience:

Required:

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 in