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Senior Clinical Development Director Oncology
3 months ago
PLEASE NOTE CLOSING DATE: Monday, August 5th, 2024 at midnight US time .
Are you a physician scientist keen to progress your oncology pharma career in the innovative and exciting field of ADCs? If so, this Senior Medical Director career opportunity within GSK's Oncology Clinical Development organization is for you.
The Senior Medical Director Oncology Clinical Development will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. 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 role requires an experienced professional 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.
Note: This position requires an on-site office presence for three days a week (at a minimum) in one of GSK’s UK (London or Stevenage).
Exhibit leadership at the program and cross-functional level and 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.
# Represent Clinical Development on disease area strategy, integrated evidence and medical affairs strategy teams.
# Oversee the development of high-quality protocols 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; 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 including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions and medical data review.
# 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.
# Contribute to the clinical and technical diligence assessment of business development opportunities, as needed.
# Understand biological mechanisms, clinical strategy, scientific interpretation of disease and target-based literature.
# Represent GSK at medical meetings, advisory boards and outreach meetings as needed/appropriate.
# Serve as a core member of the Clinical Matrix Team for one or more assets in development.
# Lead Oncology Clinical Development-wide initiatives and workstreams as appropriate.
Medical Degree
# Board certification or board registration qualifications in medical oncology, hematology or internal medicine (with hematology or oncology clinical experience).
# Strong experience in pharmaceutical/biotechnology industry with prior related clinical oncology experience.
# Experience in leading oncology clinical trials, including experience with study design, data review/interpretation and the overall clinical development process.
# Documented academic and/or clinical research publication history or history of medical practice in a relevant oncology field.
# Knowledge of regulatory requirements to support registration, including knowledge and adherence to GCP principles.
Medical degree with PhD/MBA/MPH
# Experience in Oncology Drug Development
# Established personal and professional relationships with key external experts (KEEs) in medical oncology and credibility within the medical community.
# Experience in the clinical assessment of business development opportunities to expand a growing portfolio
# Demonstrates a thorough knowledge of worldwide regulatory and safety requirements as pertains to drug development, research projects, and/or market support.
# Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution.
# Demonstrated track record of quality decision-making and innovative problem resolution in critical situations.
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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology).
Where they can keep growing and look after their wellbeing.
