Medical Directors (multiple) - BCMA, ICOS, Cell Therapy, and Cancer Epigenetics Clinical Development
** GSK has multiple Medical Director positions available in Oncology Clinical Development, supporting our BCMA, ICOS, and NY ESO 1 assets. We also have a Medical Director - Cancer Epigenetics position available which focuses on pre-clinical and early clinical development of novel, preferably first-in-class drug candidates that target epigenetic molecular mechanisms dysregulated in cancer cells.
The Medical Director is responsible for all aspects related to the clinical development of either a single therapy or combinations. In this role, the Medical Director will belong to multi-functional drug development team(s) and will work closely with scientists, statisticians, and other physicians in the discovery and translational medicine groups.
The Medical Director reports within and manages clinical development team(s) consisting of physicians and clinical scientists, and will provide critical clinical guidance from the selection of a drug candidate to the initial proof-of-concept in clinical trials passing through phase I, II, and pivotal phase IIII, including regulatory filing and registration. The Medical Director also contributes scientific and medical expertise as well as expertise into clinical trial design insights to the Clinical Team(s).
- Strategic leadership for clinical development plans.
- Management of critical resources and clinical project timelines.
- Preparation, design, and/or review of clinical documents, e.g. protocols, investigator’s brochures, electronic case report form (e-CRF) design.
- Immuno-Oncology Clinical Trial Design and optimization.
- Data optimization and eCRF creation, optimization, and finalization.
- Participate in interpretation of data analyses of clinical trial results and reports.
- Lead preparation of clinical sections of regulatory filings (IND, study reports, NDA, etc.).
- Serve as the Medical Monitor for clinical trials, to address patient eligibility and treatment questions in cooperation with the contract research organization (CRO) or directly with study investigators.
- Participation in site/investigator identification and evaluation for clinical trials; conduct site initiation and engagement calls and visits.
- Review safety data for routine medical data review, trend review, and safety signals from ongoing trials.
- Serve as program medical expert for internal and external collaborators, investigators, consultants, and contract resources.
- Contribute to scientific affairs by authoring and / or reviewing abstracts, presentations and manuscripts for medical accuracy and content.
- Attend and provide medical support for investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards).
- Develop and manage relationships with key opinion leaders for clinical programs.
Qualifications, Experience, and Skills:
- M.D. or M.D./Ph.D with Board certification/eligibility, and clinical experience in oncology or hematology/oncology and/or cell therapies.
- At least five years' pharmaceutical or relevant scientific/medical/clinical experience.
- Early clinical trial (Phase I and II) and/or late (phase III) experience in pharmaceutical or biotech industries, or equivalent academic and Clinical Oncology experience, especially Immuno-Oncology, preferred.
- Understanding and track record in trial design, conduct, and medical monitoring.
- Excellent strategic planning, organizational, and communication skills.
- Managerial experience working within or leading high-performance, cross-functional matrix teams.
- For BCMA: Experience in multiple myeloma or other liquid cancer clinical development required.
- For ICOS: Solid tumor experience in NSCLC, SCC, and/or Head & Neck clinical development required.
- For NY ESO 1: Cell therapy experience required. Solid tumor experience in NSCLC and/or Sarcoma clinical development is preferred.
- For Cancer Epigenetics: Experience with and/or career interest with relevant background in the field of experimental cancer epigenetics is strongly preferred.
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