GlaxoSmithKline
Medical Director- Oncology Clinical Development - B7-H3
GlaxoSmithKline, Waltham, Massachusetts, United States, 02254
Site Name:
USA - Pennsylvania - Upper Providence, Switzerland - Zug, UK - Hertfordshire - Stevenage, UK – London – New Oxford Street, USA - Massachusetts - Waltham, Warsaw Rzymowskiego 53Posted Date:
Oct 24 2024Are you a pharma physician or academic clinician keen to be part of GSK's growing oncology antibody drug conjugate (ADC) portfolio for the treatment of solid tumors in GI, GU and beyond? If so, this position is a must to consider.THE POSITION:
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 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.Key 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.Why You?
Basic Qualifications Include:Medical degree with board certification/eligibility or registration qualifications in medical oncology; hematology; hematology/oncology; general surgery or internal medicine.Experience in the pharmaceutical/biotechnology industry; clinical academic medicine or clinical medical practice settings in the field of 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.Preferred Qualifications include:Oncology clinical research and drug development experience focused on GI/colon rectal cancer or GU/prostate cancer.Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution.Please visit
GSK US Benefits Summary
to learn more about the comprehensive benefits program GSK offers US employees.Why GSK?GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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USA - Pennsylvania - Upper Providence, Switzerland - Zug, UK - Hertfordshire - Stevenage, UK – London – New Oxford Street, USA - Massachusetts - Waltham, Warsaw Rzymowskiego 53Posted Date:
Oct 24 2024Are you a pharma physician or academic clinician keen to be part of GSK's growing oncology antibody drug conjugate (ADC) portfolio for the treatment of solid tumors in GI, GU and beyond? If so, this position is a must to consider.THE POSITION:
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 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.Key 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.Why You?
Basic Qualifications Include:Medical degree with board certification/eligibility or registration qualifications in medical oncology; hematology; hematology/oncology; general surgery or internal medicine.Experience in the pharmaceutical/biotechnology industry; clinical academic medicine or clinical medical practice settings in the field of 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.Preferred Qualifications include:Oncology clinical research and drug development experience focused on GI/colon rectal cancer or GU/prostate cancer.Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution.Please visit
GSK US Benefits Summary
to learn more about the comprehensive benefits program GSK offers US employees.Why GSK?GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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