GSK
Overview
Medical Director, Oncology Clinical Development. The Medical Director will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. The role is responsible for clinical research activities pertaining to advancing the development of GSK’s clinical portfolio and for engaging in medical dialogues with relevant scientific and medical leaders to lead clinical data generation activities. This individual will also have a leading role in managing relationships with Key External Experts. This role requires a physician capable of developing and executing oncology clinical trials in support of successful clinical development, regulatory filing and initial market launch of a growing portfolio of innovative oncology agents. This position requires on-site 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 determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe Contribute to end-to-end study delivery (protocol concept to final study report) to ensure scientific integrity and timely delivery of trials aligned with regulatory approvals, lifecycle management, and global considerations Interpret and summarize study results to define safety, efficacy, pharmacokinetic/pharmacodynamic data, and patient-reported outcomes for the targeted population Assume medical responsibility for clinical trials, including real-time medical monitoring, patient eligibility assessment, study design questions, and urgent safety questions (with PV as relevant) Provide medical review of clinical trial data or oversee delegated medical review; oversee blinded review of data for IDMCs Review/monitor safety data in collaboration with the pharmacovigilance group for active studies Participate in the authoring of clinical study reports and regulatory documents; collaborate with Regulatory Affairs, CMC, Toxicology, Research, and Pharmacology to respond to health authority and ethics queries Collaborate with Principal Investigators on publications (abstracts, posters, manuscripts) related to clinical data Develop long-term strategic partnerships with thought leaders internally and externally to support GSK’s vision Understand biological mechanisms, clinical strategy, and 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 Basic Qualifications
Medical degree with completion of post-medical education clinical residency Board/registration qualifications in medical oncology, hematology, pathology or internal medicine Oncology experience in pharmaceutical/biotechnology industry and clinical practice in the fields noted Documented academic and/or clinical research publications or history of medical practice in the fields noted Strong working knowledge of the clinical drug development process with experience in conducting/participation of clinical trials and 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 Experience leading oncology clinical trials, including study design, data review/interpretation and overall development process Knowledge of disease-specific research priorities, public health needs, competitor landscape, practice trends and treatment guideline evolution Why GSK?
GSK is a global biopharma company focused on uniting science, technology and talent to get ahead of disease. We aim to positively impact the health of people by advancing innovation in four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. We are committed to an environment where our people can thrive and deliver for patients, shareholders and each other. If you require accommodation or assistance to apply, contact the GSK Service Centre.
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Medical Director, Oncology Clinical Development. The Medical Director will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. The role is responsible for clinical research activities pertaining to advancing the development of GSK’s clinical portfolio and for engaging in medical dialogues with relevant scientific and medical leaders to lead clinical data generation activities. This individual will also have a leading role in managing relationships with Key External Experts. This role requires a physician capable of developing and executing oncology clinical trials in support of successful clinical development, regulatory filing and initial market launch of a growing portfolio of innovative oncology agents. This position requires on-site 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 determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe Contribute to end-to-end study delivery (protocol concept to final study report) to ensure scientific integrity and timely delivery of trials aligned with regulatory approvals, lifecycle management, and global considerations Interpret and summarize study results to define safety, efficacy, pharmacokinetic/pharmacodynamic data, and patient-reported outcomes for the targeted population Assume medical responsibility for clinical trials, including real-time medical monitoring, patient eligibility assessment, study design questions, and urgent safety questions (with PV as relevant) Provide medical review of clinical trial data or oversee delegated medical review; oversee blinded review of data for IDMCs Review/monitor safety data in collaboration with the pharmacovigilance group for active studies Participate in the authoring of clinical study reports and regulatory documents; collaborate with Regulatory Affairs, CMC, Toxicology, Research, and Pharmacology to respond to health authority and ethics queries Collaborate with Principal Investigators on publications (abstracts, posters, manuscripts) related to clinical data Develop long-term strategic partnerships with thought leaders internally and externally to support GSK’s vision Understand biological mechanisms, clinical strategy, and 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 Basic Qualifications
Medical degree with completion of post-medical education clinical residency Board/registration qualifications in medical oncology, hematology, pathology or internal medicine Oncology experience in pharmaceutical/biotechnology industry and clinical practice in the fields noted Documented academic and/or clinical research publications or history of medical practice in the fields noted Strong working knowledge of the clinical drug development process with experience in conducting/participation of clinical trials and 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 Experience leading oncology clinical trials, including study design, data review/interpretation and overall development process Knowledge of disease-specific research priorities, public health needs, competitor landscape, practice trends and treatment guideline evolution Why GSK?
GSK is a global biopharma company focused on uniting science, technology and talent to get ahead of disease. We aim to positively impact the health of people by advancing innovation in four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. We are committed to an environment where our people can thrive and deliver for patients, shareholders and each other. If you require accommodation or assistance to apply, contact the GSK Service Centre.
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