The Association of Technology, Management and Applied Engineering
Medical Director- Oncology Clinical Development
The Association of Technology, Management and Applied Engineering, Chicago, Illinois, United States, 60290
Position Summary
GSK Oncology Clinical Development is seeking a highly skilled and motivated Clinical Development Medical Director - Oncology to join our dynamic Oncology Research and Development team. In this role the successful candidate will create a strong link between Clinical Development and other functions in the clinical matrix team to increase the success of our Oncology clinical portfolio in the GU cancer space.
Key Responsibilities
Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others in a complex matrix environment to develop and execute early phase interventional clinical trials for patients with prostate cancer.
Ensure high quality protocol development aligned with the overall Clinical Development Plan for assets 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 prostate cancer 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 review of data packages intended for internal and/or external 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 data during dose escalation and expansion studies and subsequent 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? We are looking for professionals with these required skills to achieve our goals:
Basic Qualifications
Medical degree from accredited medical school
Completion of a clinical residency program
Experience in clinical research and development in Oncology
Experience working in the pharmaceutical/biotechnology industry in GU prostate cancer.
Preferred Qualifications
Oncology experience in pharmaceutical/biotechnology industry preferred
Experience in leading oncology clinical trials, including experience with 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
Experience in regulatory requirements to support registration, including knowledge and adherence to GCP principles
Compensation and Benefits Compensation ranges vary by location and include base salary, annual bonus, and share-based long‑term incentive program eligibility. Benefits include health care, retirement, paid holidays, vacation, and paid parental leave. For specific salary ranges, please discuss with our recruiting team during the recruitment process. For more details on the total reward package applicable to your role, additional information will be provided during the recruitment process. To learn more about the comprehensive benefits program, visit
GSK US Benefits Summary .
Why GSK? GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade and foster a culture ambitious for patients, accountable for impact, and committed to doing the right thing.
Contact Should you require any adjustments or have questions, contact
HR.AmericasSC-CS@gsk.com . For questions unrelated to adjustments we provide a recruitment FAQ guide; please click the link to view answers.
Equal Opportunity Employer 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.
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Key Responsibilities
Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others in a complex matrix environment to develop and execute early phase interventional clinical trials for patients with prostate cancer.
Ensure high quality protocol development aligned with the overall Clinical Development Plan for assets 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 prostate cancer 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 review of data packages intended for internal and/or external 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 data during dose escalation and expansion studies and subsequent 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? We are looking for professionals with these required skills to achieve our goals:
Basic Qualifications
Medical degree from accredited medical school
Completion of a clinical residency program
Experience in clinical research and development in Oncology
Experience working in the pharmaceutical/biotechnology industry in GU prostate cancer.
Preferred Qualifications
Oncology experience in pharmaceutical/biotechnology industry preferred
Experience in leading oncology clinical trials, including experience with 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
Experience in regulatory requirements to support registration, including knowledge and adherence to GCP principles
Compensation and Benefits Compensation ranges vary by location and include base salary, annual bonus, and share-based long‑term incentive program eligibility. Benefits include health care, retirement, paid holidays, vacation, and paid parental leave. For specific salary ranges, please discuss with our recruiting team during the recruitment process. For more details on the total reward package applicable to your role, additional information will be provided during the recruitment process. To learn more about the comprehensive benefits program, visit
GSK US Benefits Summary .
Why GSK? GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade and foster a culture ambitious for patients, accountable for impact, and committed to doing the right thing.
Contact Should you require any adjustments or have questions, contact
HR.AmericasSC-CS@gsk.com . For questions unrelated to adjustments we provide a recruitment FAQ guide; please click the link to view answers.
Equal Opportunity Employer 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.
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