MUST BE BASED IN THE UK TO BE ELIGIBLE.

Job Title: Medical Director - Oncology Clinical Development

Contract Length: 6 Months

Location: London or Stevenage

Overview

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We are on an audacious journey to impact the health of 2.5 billion people over the next decade. Our R&D division is at the forefront of this mission, dedicated to the discovery and development of groundbreaking vaccines and medicines. We are transforming the landscape of medical research by integrating cutting-edge science and technology and harnessing the power of genetics and new data. By fostering a collaborative environment that unites the talents of our people, we are revolutionizing R&D to pre-empt and defeat diseases. Join us in our commitment to uniting science, technology, and talent to get ahead of disease together.

Role Overview

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 Sarcoma space.

The Clinical Development Medical Director- Oncology 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 for patients with Sarcoma.

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.

Minimum Requirements

We are looking for professionals with these required skills to achieve our goals:

• Medical Degree.
• Completion of a full clinical residency program leading to board qualification or certification.
• For UK-trained physicians: Completion of Core Medical Training / Internal Medicine Training (Stage 1) or General Practice Specialty Training.
• For International physicians (who trained outside of the US and UK): completion of a nationally recognized, structured training program, that includes a minimum of three years supervised clinical rotations.
• Experience in clinical research and development in Oncology.

Preferred Requirements

• Completion of a clinical medical sub-specialty training (leading to additional board eligibility/certification, CCT or fellowship/membership in a national medical board for the relevant specialty) in Oncology.
• PhD preferred.
• Experience working in the pharmaceutical/biotechnology industry in Sarcoma.
• 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.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Inclusion at GSK

GSK is an Equal Opportunity/Affirmative Action Employer. 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.

If you need any adjustments in the recruitment process, please get in touch with our Recruitment team (EMEA-GSKLink@allegisglobalsolutions.com) to further discuss this today.

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