Medical Director, Oncology Clinical Development

GSK • Waltham, MA

2d • Onsite

About The Position

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, Breast and Gynecologic Cancers will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. The Medical Director will be responsible for clinical research activities pertaining to advancing the development of GSK’s clinical portfolio and will also have responsibility for engaging in medical dialogues with relevant scientific and medical leaders so as to lead clinical data generation activities. This individual will also have a leading role in managing effective relationships with Key External Experts. This position will support our growing oncology antibody drug conjugate (ADC) portfolio for the treatment of solid tumors. The incumbent 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 (PA or MA), Switzerland (Zug) or Poland (Warsaw) campuses.

Requirements

• Medical degree from accredited medical school
• Completion of a clinical residency program
• Clinical experience in medical oncology, hematology, or gyn oncology
• Experience in clinical research and development

Nice To Haves

• Oncology clinical research and drug development experience focused on Gynecologic Cancer or Breast cancer
• Experience in the pharmaceutical/biotechnology industry; clinical academic medicine or clinical medical practice settings in the field of oncology or gynecologic oncology.
• Oncology clinical drug development process experience in the conduct/participation of clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications.
• Regulatory experience to support registration and GCP principle
• Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution

Responsibilities

• Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, 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.
• Use medical expertise to contribute to the end to end (protocol concept to final study report) to ensure scientific integrity and timely delivery of clinical trials which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into decision making
• 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.
• Assume medical responsibility for clinical trials with active participation in real-time medical monitoring of studies, 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 as needed 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.
• Participate in the authoring of clinical study reports and regulatory documents and collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries.
• Collaborate with Principal Investigators in the evaluation and assessment 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.
• Understand biological mechanisms, clinical strategy, scientific interpretation of disease and target-based literature.
• Serve as a core member of the Clinical Matrix Team for one or more assets in development.
• Represent Clinical Development on disease area strategy, integrated evidence and medical affairs strategy teams.
• Participate in Oncology Clinical Development-wide initiatives and workstreams as appropriate.

Benefits

• health care and other insurance benefits (for employee and family)
• retirement benefits
• paid holidays
• vacation, and paid caregiver/parental and medical leave
• annual bonus
• eligibility to participate in our share based long term incentive program which is dependent on the level of the role

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees