GSK
Medical Director, Oncology Clinical Development
GSK, Waltham, Massachusetts, United States, 02254
Medical Director, Oncology Clinical Development
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Posted Date: Sep 18 2025
Overview The Medical Director, Oncology Clinical Development 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 in order to lead clinical data generation activities. This individual will also have a leading role in managing effective relationships with Key External Experts. This role requires a physician capable of developing and executing oncology clinical trials in support of the successful clinical development, regulatory filing and initial market launch of a growing portfolio of innovative and transformational Oncology agents.
On-site requirement Please note: This position requires an on-site office-based presence 2 to 3 days a week in the UK (London or Stevenage); Switzerland (Zug); US (Upper Providence, PA; Waltham, MA or Boston, MA); or Poland (Warsaw).
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
Qualifications
Medical degree with completion of post medical education clinical residency training
Board/registration qualifications in medical oncology, hematology, pathology or internal medicine
Oncology experience in pharmaceutical/biotechnology industry and clinical practice experience in the fields noted above
Documented academic and/or clinical research publication history or history of medical practice in the fields noted above
Strong working knowledge of the clinical drug development process with experience in the conduct/participation of clinical trials and their subsequent publications
Experience in regulatory requirements to support registration, including knowledge and adherence to GCP principles
Preferred Qualifications
Board/registration certified or eligible physician with a PhD degree
Experience in leading oncology clinical trials, including study design, data review/interpretation and the overall clinical development process
Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution
Why GSK? GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We focus on four therapeutic areas: oncology; and other areas of focus. We are committed to creating an environment where our people can thrive and where we deliver for patients, shareholders and our people. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre.
Equal Opportunity GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.
Notes Please note that GSK does not accept referrals from employment businesses and/or employment agencies for vacancies posted on this site. All employment businesses/agencies must contact GSK to obtain prior written authorization before referring candidates.
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Posted Date: Sep 18 2025
Overview The Medical Director, Oncology Clinical Development 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 in order to lead clinical data generation activities. This individual will also have a leading role in managing effective relationships with Key External Experts. This role requires a physician capable of developing and executing oncology clinical trials in support of the successful clinical development, regulatory filing and initial market launch of a growing portfolio of innovative and transformational Oncology agents.
On-site requirement Please note: This position requires an on-site office-based presence 2 to 3 days a week in the UK (London or Stevenage); Switzerland (Zug); US (Upper Providence, PA; Waltham, MA or Boston, MA); or Poland (Warsaw).
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
Qualifications
Medical degree with completion of post medical education clinical residency training
Board/registration qualifications in medical oncology, hematology, pathology or internal medicine
Oncology experience in pharmaceutical/biotechnology industry and clinical practice experience in the fields noted above
Documented academic and/or clinical research publication history or history of medical practice in the fields noted above
Strong working knowledge of the clinical drug development process with experience in the conduct/participation of clinical trials and their subsequent publications
Experience in regulatory requirements to support registration, including knowledge and adherence to GCP principles
Preferred Qualifications
Board/registration certified or eligible physician with a PhD degree
Experience in leading oncology clinical trials, including study design, data review/interpretation and the overall clinical development process
Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution
Why GSK? GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We focus on four therapeutic areas: oncology; and other areas of focus. We are committed to creating an environment where our people can thrive and where we deliver for patients, shareholders and our people. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre.
Equal Opportunity GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.
Notes Please note that GSK does not accept referrals from employment businesses and/or employment agencies for vacancies posted on this site. All employment businesses/agencies must contact GSK to obtain prior written authorization before referring candidates.
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