Medical Director, Oncology Clinical Development
Medical Director, Oncology Clinical Development
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Job Description
The Medical Director Oncology Clinical Development 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 GSKs 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
Please note: This position requires an on-site office -based 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).
Key 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 effectively determine a medicines 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 GSKs 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.
Why you
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Medical degree with completion of post medical education clinical residency training
- Board/registration qualifications in medical oncology hematology pathology or internal medicine
- 3 years of oncology experience in pharmaceutical/biotechnology industry and clinical practice experience in the fields noted above
- Documented academic and/or clinical research publication history or history of medical practice in the fields noted above.
- Strong working knowledge of the clinical drug development process with experience in the conduct/participation of clinical trials (investigator initiated company sponsored or cooperative group trials) and their subsequent publications.
- Experience in regulatory requirements to support registration including knowledge and adherence to GCP principles
Preferred Qualifications:
If you have the following characteristics it would be a plus:
- Board/registration certified or eligible physician with a PhD degree
- Experience in leading oncology clinical trials including experience with study design data review/interpretation and the overall clinical development process
- Robust knowledge of disease-specific research priorities public health needs competitor landscape clinical practice trends and treatment guidelines evolution
Why GSK
Uniting science technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade as a successful growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale.
People and patients around the world count on the medicines and vaccines we make so were committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients accountable for impact and doing the right thing is the foundation for how together we deliver for patients shareholders and our people.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race color religion sex (including pregnancy gender identity and sexual orientation) parental status national origin age disability genetic information (including family medical history) military service or any basis prohibited under federal state or local law.
We believe in an agile working culture for all our roles. If flexibility is important to you we encourage you to explore with our hiring team what the opportunities are.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on or 0. The helpline is available from 8.30am to 12.00 noon Monday to Friday during bank holidays these times and days may vary.
Please note should your enquiry not relate to adjustments we will not be able to support you through these channels. However we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSKs commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license GSK may be required to capture and report expenses GSK incurs on your behalf in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at Experience:
Director
Employment Type
Full-Time
Key Skills
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