Executive Director, Oncology Early Clinical Development Lead
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting‑edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, focusing on accelerating significant assets that meet patients’ needs and have the highest probability of success.
Position Summary
GSK Oncology Clinical Development is seeking a highly skilled and motivated Executive Director, Oncology Early Clinical Development Lead to join our dynamic Oncology Research and Development team. In this role the successful candidate will create a strong link between Clinical Development and Pre‑clinical/Discovery teams to improve forward and reverse translation and, thereby, increase the success of our Oncology clinical portfolio. They will be responsible for leading a team of talented Oncology Early Clinical Development Medical Directors and Clinical Scientists who will design and execute early‑phase clinical studies and contribute to the translational research strategy for early phase clinical assets.
This position requires an on‑site office‑based presence 2 to 3 days a week in the US (Upper Providence, PA or Waltham, MA), UK (London or Stevenage), Switzerland (Zug) or Poland (Warsaw).
Responsibilities
* Accountable for the clinical development plans (CDPs) for a portfolio of early phase (Phase I/II) clinical study protocols, including first‑in‑human (FIH) trials, dose‑escalation studies and proof‑of‑concept studies.
* Accountable for overall benefit‑risk of a clinical program, delegating to and working closely with the appropriate physician(s) when not a physician.
* Drive the end‑to‑end clinical development strategy and alignment to target medicine profiles (TMP) and integrated evidence plans (IEP), spanning all phases of development, including trial design, execution, interpretation and delivery of trial results.
* Lead clinical development discussions and teams at regulatory interactions and be accountable for drafting clinical components of regulatory submissions (IND, NDA, BLA, MAA) including briefing documents and presentations.
* Participate as a core member of the Medicine Development Team (MDT) or Early Development Team (EDT) and provide single Clinical Development accountability at the program level within cross‑functional partnerships.
* Ensure all clinical studies comply with applicable regulatory requirements, Good Clinical Practice (GCP) guidelines and GSK policies.
* Lead the cross‑functional Clinical Matrix Team and provide clinical leadership, Oncology Clinical Development expertise and customer insight for the program.
Translational Research Strategy
* Oversee the development and execution of clinical development components of the overall translational science strategy in partnership with Oncology Early Development Leaders, Oncology Translational Science, pre‑clinical teams, AI/ML, Clinical Pharmacology & Experimental Medicine and Research Technologies.
* Partner with Oncology Tumor Teams (OTTs) to develop translational strategy across assets within a given tumour and drive OTT activities with a clinical and translational focus.
* Drive advancements in translational research and emerging technologies to improve study designs and foster innovation.
Data Analysis and Interpretation
* Interpret complex translational and clinical data, identify trends, consult on safety analyses and respond to health authority queries.
* Author and/or review abstracts, presentations and manuscripts for accuracy of clinical data, interpretation and content.
* Prepare for governance discussions in close collaboration with cross‑functional teams and business lines.
* Lead preparation of clinical sections of regulatory filings (IND, study reports, NDA, annual reports).
* Provide clinical support for investigator and consultant meetings.
* Present study results and translational insights to internal and external stakeholders, including senior management, scientific advisory boards and regulatory agencies.
Collaboration and Communication
* Integrate inputs from research, clinical, medical, scientific, commercial, regulatory, manufacturing and operations disciplines to ensure alignment and successful execution of translational research initiatives.
* Build and maintain strong relationships with key external experts, academic collaborators and external research organisations.
* Collaborate with Principal Investigators and Steering Committees in evaluating publications associated with clinical data.
* Serve as program medical expert for internal and external collaborators, investigators and consultants.
Oncology Clinical Development Leadership
* Lead, coach and mentor a team of Oncology Early Clinical Development Medical Directors and Clinical Scientists, providing ongoing coaching, development and leadership.
* Guide direct reports to ensure cross‑functional integration and alignment to enable efficient CDP and translational strategy execution.
* Foster a culture of bold, swift, integrity and community within the team.
* Contribute to establishment of standards for clinical documents and data review processes across Oncology Clinical Development.
Basic Qualifications
* Advanced degree, PhD or PharmD.
* Clinical and research experience in oncology.
* Experience designing and executing early‑phase clinical trials, including FTIH and POC, and translational research.
* Knowledge of oncology treatment guidelines, clinical development process and drug approval process in major regions.
* Experience developing and driving translational strategy: biomarker, companion diagnostic, PK/PD modeling and simulation.
Preferred Qualifications
* MD (preferred).
* Board certification or clinical experience in oncology.
* Experience in the gastro‑intestinal therapeutic area (highly preferred).
* In depth knowledge of GCP, ICH, FDA, EMEA, NICE and other relevant guidelines and regulations.
* Broad experience in data analysis, interpretation and clinical relevance.
* Experience leading matrix teams and motivating high performance.
* Strong business acumen.
* In deep knowledge of medical and drug terminology and a foundation in pharmacology.
* Highly effective communication skills; able to present complex data, design and strategy to all levels.
* Demonstrated ability to produce clear, accurate scientific communications compliant with GSK disclosure and publication controls.
* Track record of quality decision making and creative problem resolution.
* Ability to adjust behaviours and priorities based on changing environment.
* Ability to engage in Oncology Clinical Development culture with confidence, impact, integrity and professionalism.
* Understanding of adverse effects investigation and prevention.
* Highly developed negotiating and influencing skills.
Compensation & Benefits
• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary ranges from $242,550 to $404,250. • If you are based in another US location, the annual base salary range is $220,500 to $367,500. The range reflects location, skills, experience and market conditions. The position also offers an annual bonus and participation in our share‑based long‑term incentive program. Benefits include health care, retirement, paid holidays, vacation and paid caregiver/parental and medical leave.
Equal Opportunity Statement
GSK is an Equal Opportunity Employer. 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, military service or other protected statuses.
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