Medical Director/Senior Medical Director - Oncology Clinical Development- Multiple Myeloma
Are you a pharma Medical Director who would you be keen to join GSK's oncology clinical development organization as it continues its commitment to improve the lives of patients with multiple myeloma? If so, then this career opportunity at GSK is a must to consider.
Our Oncology R&D organization is building a diverse portfolio of Oncology medicines, focused on maximizing patient survival through transformation medicines. We aim to deliver first-to-market and first-in-class solutions that have the potential to address some of the biggest challenges in oncology.
Our organization covers the entire research and development spectrum from discovery to clinical development and regulatory compliance. We partner with other R&D functions, including Commercial and Medical to build our pipeline, manage trials, and progress from development to commercialization. We also pursue and manage critical business development opportunities, collaborations and acquisitions to advance our mission.
GSK continues to be committed to the discovery and development of new oncology therapies with the life-changing potential of helping patients with cancer:
• Immuno-Oncology – Focused on an innovative pipeline of immune modulators designed to leverage a patient’s immune system to recognize and eradicate solid and liquid tumors.
• Tumor Cell Targeting – Target tumor-specific alterations to introduce selective anti-cancer activity.
• Synthetic Lethality – Optimizing the use of PARP-inhibitors and delivering a Repertoire of Synthetic Lethal Medicines.
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(Please note that depending on experience, this position may be considered at the Medical Director level)
The Senior Medical Director Oncology Clinical Development will report to the Group Sr. Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. The Sr. 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 internal 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 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.
- 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; 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 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 blinded review of data packages intended for 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 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.
BASIC QUALIFICATIONS for Senior Medical Director:
- MD or equivalent
- Board certification/ qualifications (or international equivalent) in medical oncology, hematology or internal medicine (with hematology or oncology research experience)
- 5+ years of experience in pharmaceutical/biotechnology industry or related clinical experience
- 3+ years of 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 a relevant field of hematology/oncology.
- Knowledge of regulatory requirements to support registration, including knowledge and adherence to GCP principles
- Please note this position may be designated at the Medical Director level depending on experience in an academic setting and/or pharmaceutical setting.
M.D. PhD degree
7+ years of experience in pharmaceutical industry or related clinical experience
5+ years of 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
Highly developed communication and interpersonal skills appropriate to the target audience and senior stakeholders, promoting effective decision-making in a highly matrixed environment
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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
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.
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. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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.
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