Description
Who we are:
Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives.
Job Description:
The Clinical Science role at Calico is responsible for the planning and execution of the translational and clinical development plans and protocols of several projects related to Calico's mission to improve human health span by understanding aging and age-related diseases. The successful candidate would participate/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.
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.
* Primary 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 Pharmacology, Clinical Biostatistics, Safety Science, and Toxicology.
* 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 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.
* May participates in the assessment of CROs and study vendors.
Qualifications:
* Bachelors degree required; advanced degree in an area of discipline relevant for pharmaceutical development preferred (PhD, Pharm D, MS)
* 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.
* 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
