Associate Director/Director, Clinical Pharmacology

About the position

The Associate Director/Director, Clinical Pharmacology role at Calico is responsible for the planning and execution of the translational and early clinical development plans and protocols of several projects related to Calico's mission to improve human healthspan by understanding aging and age-related diseases. The successful candidate would participate/drive the development of early clinical strategies, especially first-in-human, clinical pharmacology, and exploratory clinical biomarker studies for assigned program(s)/indication(s) and should be able to support novel and innovative clinical plans while ensuring a positive and collaborative team environment.

Responsibilities

• In coordination with the Head of Clinical Science and/or Medical Director(s), leads or represents the Clinical Pharmacology function in cross-functional project and study teams that develop and execute the early clinical development plan to translate preclinical mechanistic data to humans for novel aging-related targets
• Design and oversee execution of the Clinical Pharmacology strategy for portfolio programs, including first-in-human protocols to determine initial safety, tolerability, and pharmacokinetics and other Clinical Pharmacology studies to support early development, including ADME, DDI, TQT, Renal and Hepatic Impairment studies
• Contributes to the design and execution of experimental medicine studies to demonstrate proof-of-mechanism of novel targets in aging and age-related diseases
• Contributes to the design and execution of Phase 2 studies, including the dose selection strategy
• Primary author or contributing author for assigned clinical protocols from Phase 0 through Phase 2, collaborating with and coordinating other functions required for protocol development, including Research, Biomarkers, Clinical Operations, Regulatory Affairs, Clinical Biostatistics, Safety Science, and Toxicology
• Authors, contributes to, or reviews Clinical, Regulatory and relevant study documents including Investigational Brochures, Clinical Study Reports, Statistical Analysis Plans, Operations/Technical Manuals, IND/CTAs, case report forms and data tables, listings and figures
• Trains CROs and study site personnel on assigned protocols and addresses protocol queries as they arise
• Participates in the assessment of CROs and study vendors

Requirements

• Advanced degree in an area of discipline relevant for pharmaceutical development (PhD, PharmD, MS)
• Modeling and Simulation expertise preferred
• At least 8 years of experience in early clinical drug development in the biotech/pharmaceutical industry performing the responsibilities described above
• Experience in early clinical trial methodology (Phase 0, Phase 1, Phase 2) and knowledge of drug development process and clinical deliverables from IND through clinical proof-of-concept
• Experience in designing and overseeing execution of first-in-human, ADME, DDI, TQT, hepatic and renal impairment studies
• Experience in overseeing and interpreting pharmacokinetic parameters in the studies outlined above
• Experience in overseeing clinical pharmacology and preclinical pharmacology functions at CROs or development partners
• Excellent understanding of clinically relevant ICH GCP guidance, FDA and EMA regulations
• Ability to perform role responsibilities largely independently
• Proven leadership skills and ability to bring out the best in others on a cross-functional team
• Able to provide effective leadership through influence across organizations on partnered programs
• Detail-oriented mindset with excellent oral and written communication skills
• Must be willing to work onsite at least 4 days a week

Benefits

• Estimated base salary range of $225,000- $295,000
• Eligible for two annual cash bonuses