Health Research Senior Manager

4 weeks ago

London, United Kingdom GlaxoSmithKline Full time

Are you a physician scientist keen to progress your pharma career within GSK’s Oncology Research Unit and clinically assess business development opportunities to expand a growing portfolio and improve the lives of cancer patients? If so, this Senior Medical Director career opportunity within GSK is an excellent opportunity to explore.
GSK’s Oncology Research Unit is committed to maximising patient survival with a current focus on haematologic malignancies, gynaecologic cancers and other solid tumours through breakthroughs in immuno-oncology and tumour-cell targeting therapies.
The Senior Medical Director, Oncology Research Unit will report to the Vice President, Oncology, New Opportunities and Pipeline Strategy - Oncology Research Unit. Medical Director will lead and conduct clinical assessments, including due diligence assessments, of external assets, as business opportunities, to advance the GSK clinical portfolio. Additionally, this role will be responsible for clinical assessment activities, to support GSK’s Oncology business development objectives. They will also have responsibility for engaging in medical dialogues with relevant internal and external scientific and medical leaders, to support these objectives.
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.
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) campuses.
Exhibit leadership, at the program and cross-functional level and collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, business development, executive staff and others, in a complex matrix environment.
# Contribute to the technical diligence assessments and lead clinical assessment of GSK Oncology business development opportunities.
# Lead the development of high-quality Clinical Development Plans, capable of determining a medicine’s potential efficacy, safety profile, key areas of product differentiation and delivering value to the patient, as rapidly and efficiently as possible.
# Represent Clinical Development on disease area strategy, integrated evidence and medical affairs strategy teams, as required.
# Use medical expertise, in the context of clinical trial planning, to ensure scientific integrity and timely delivery, whilst also ensuring consistency with the GSK Oncology portfolio strategy and with GSK company standards.
# Interpret and summarize study results, for safety, efficacy, pharmacokinetic/pharmacodynamic, patient reported outcomes, and describe their relevance to the targeted patient population and to the GSK Oncology portfolio strategy.
# Assume responsibility for medical review of clinical trial data, both directly and/or via oversight of delegated medical review.
# Participate in the authoring of the clinical components of due diligence reports and collaborate with colleagues in Patient Safety, Biostatistics, Regulatory Affairs, CMC, Toxicology, Research, Pharmacology and Business Development on multidisciplinary teams.
# Network extensively, to develop long-term strategic partnerships with thought leaders, both internally and externally, in support of GSK’s strategic vision.
# Keep up to date, with latest advances in clinical practice and science, relevant to oncology and haemato-oncology.
# Represent GSK at medical meetings, advisory boards and outreach meetings, as required.
# Serve as a core member of the multidisciplinary Due Diligence Team, for one or more assets under assessment.
# Lead and/or participate in GSK Oncology Research Unit initiatives and workstreams as required.
# Assist as an advisor/support clinical development activities ad-hoc or as required.

Medical Degree.
# Board certification or board/registration qualifications in medical oncology, radiation oncology, haematology or internal medicine (with haematology or oncology experience).
# Experience in pharmaceutical/biotechnology industry or related clinical 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 field.
# Knowledge of regulatory requirements to support registration, including knowledge and adherence to GCP principles.
# Experience in the clinical assessment of business development opportunities to expand a growing portfolio.

Medical degree with PhD/MBS/MPH.
# Strong experience in Oncology Drug Development.
# Established personal and professional relationships with key external experts (KEEs) in medical oncology and credibility within the medical community.
# 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.

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).
Where they can keep growing and look after their wellbeing.

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