Associate Director, Clinical Scientist
About The Position
The Associate Director, Clinical Scientist at Calico is responsible for the planning and execution of the translational and clinical development plans and protocols for several projects across therapeutic areas, related to Calico’s mission to improve human healthspan by understanding aging and age-related diseases. The successful candidate will participate in and drive the development of clinical strategies 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.
Requirements
- BS/MS in a relevant scientific discipline with 8+ years or PhD/PharmD with 5+ 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
- 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 English communication skills
- Must be willing to work onsite at least 4 days a week
Responsibilities
- In coordination with the Head of Clinical Science and/or Medical Director(s), leads or represents the Clinical Science function in cross-functional project and study teams that develop and execute the clinical development plan to translate preclinical mechanistic data to humans for novel aging-related targets
- Authors clinical sections of assigned protocols from Phase 0 through Phase 2, collaborating with other functions required for protocol development, including Research, Biomarkers, Clinical Operations, Regulatory Affairs, Clinical Pharmacology, Biometrics, Pharmacovigilance, Toxicology, and Medical Writing
- Contributes to the design and execution of experimental medicine studies to demonstrate proof-of-mechanism of novel targets in aging and age-related diseases
- Interfaces with academic investigators to assist in execution of Investigator initiated trials
- Contributes to and/or reviews 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, CSRs
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
