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Project Development Chef

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United Kingdom Planet Pharma Full time

Director, Early Clinical Development Physician is responsible for working primarily across early-stage clinical programs across the organization. The role will assume responsibility for one or more phase 1/1b/2 clinical studies and work closely with the R&D line function on preclinical programs to ensure appropriate planning for the filing of INDs to become the clinical program lead on first in human (FIH) studies for these molecules.

Provide medical leadership for assigned clinical trials/programs including phase 1b/II
Acts as director of clinical development strategies, working with team members in the US and Europe in clinical operations, regulatory affairs, preclinical development and statistics to:
develop (or support development) and proposes the Clinical Development Plan
define regulatory strategy
provide medical/scientific input and develop/review relevant clinical documents or parts thereof to ensure high quality of e.g. study concept sheets, study protocols and reports, Investigator Brochures, submission/registration documents, publications, etc.
supervise the review, analysis and interpretation of study data
write abstracts and manuscripts for publication of clinical data and results in collaboration with clinical scientists and external providers, as applicable
Acts as a Study and/or Project Team representative, participating in cross-functional development activities to provide medical/scientific input into e.g. business plan, project strategy, in/out licensing activities, etc. The successful candidate will be an innovative, sophisticated, and highly creative individual who thrives in a “get it done” type of environment with a strong track record of hands-on experience in oncology clinical development. Medical degree and training from a recognized academic institution. 8+ of experience in Clinical Development in industry or academia designing and overseeing clinical trials in oncology.
~ Strong knowledge and expertise in clinical oncology and experience in clinical and drug development.
~ Solid knowledge of preclinical oncology research methodology to enable interpretation of preclinical data for devising clinical hypotheses and clinical planning purposes
~ Creative, innovative and self-starter.