Collaborate with physicians, scientists, regulatory professionals, biostatisticians, executive staff, and others in a complex matrix environment to develop and execute phase 1-3 interventional clinical trials
Ensure high-quality protocol development aligned with the Clinical Development Plan to effectively determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe.
Assume medical responsibility for clinical trials with active participation in real-time medical monitoring, including patient eligibility assessment, study design questions, and addressing urgent safety questions (with inclusion of Safety/ PV as relevant).
Assume responsibility for medical review of clinical trial data, both directly and/or via oversight of delegated medical review. Oversee blinded review of data packages intended for IDMCs.
Review/monitor safety data in collaboration with pharmacovigilance group for active clinical studies.
Interpret and summarize study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population.
Participate in the authoring of clinical study reports and regulatory documents and collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, and Pharmacology to respond to health authority and ethics committee queries.
Collaborate with Principal Investigators in the authoring of publications (abstracts, posters, manuscripts) associated with clinical data.
Network extensively to develop long-term strategic partnerships with thought leaders both internally and externally, in support of GSK's vision.
Serve as a core member of the Clinical Matrix Team for one or more assets in development.
Participate in Oncology Clinical Development-wide initiatives and workstreams as appropriate.
Requirements
We are looking for professionals with these required skills to achieve our goals:
Medical degree with board certification/eligibility or registration qualifications in medical oncology, hematology or hematology/oncology
Experience in the pharmaceutical/biotechnology industry, clinical academic medicine, or clinical medical practice, in the field of hematology and/or oncology
Oncology clinical drug development experience in the conduct of clinical trials (investigator-initiated, company-sponsored or cooperative group trials) and their subsequent publications
If you have the following characteristics, it would be a plus:
MD / PhD preferred
Clinical experience of managing patients with hematological malignancies
Oncology clinical research and drug development experience focused on hematological malignancies, including multiple myeloma
Sound understanding of biological mechanisms, clinical strategy, scientific interpretation of disease and target-based literature
Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends, and treatment guidelines evolution
If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary
Benefits
Health insuranceVision insurance
Additional Information
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.
Find out more: Our approach to R&D
The Medical Director, Oncology Clinical Development will report to the Executive Medical Director / Clinical Development Lead (CDL), Oncology Clinical Development. This position will support our growing oncology portfolio for the treatment of hematological malignancies. The Medical Director will have the opportunity to work across early- to late-stage development and in partnership with a multi-disciplinary team of oncology drug developers.
An on-site office presence for a minimum of two days a week is required in one of GSK's UK (London or Stevenage), US (Greater Philadelphia or Waltham), Switzerland (Zug) or Poland (Warsaw) campuses.
Gsk · - Pennsylvania - Upper Providence