Executive Medical Director, Early Clinical Development Lead - Oncology - Lung & Head/Neck Cancers

GSK • Waltham, PA

2d • Hybrid

About The Position

GSK Oncology Clinical Development is seeking an Executive Medical Director, Oncology Early Clinical Development Lead to connect Clinical Development with preclinical and discovery teams, strengthen forward and reverse translation, and improve the success of the Oncology clinical portfolio. The role leads Oncology Early Clinical Development Medical Directors and Clinical Scientists who design and execute early-phase studies and contribute to translational research strategy. It bridges preclinical research and clinical development to support translation of therapies from the laboratory to clinical studies.

The position is accountable for clinical development plans and benefit-risk assessments for a portfolio of Phase I/II programs, including first-in-human, dose-escalation/expansion, and proof-of-concept studies. It leads end-to-end clinical development strategy across development phases, aligned with target medicine profiles and integrated evidence plans, and leads clinical development discussions at regulatory interactions. The role also provides clinical leadership for cross-functional early clinical teams, oversees clinical components of translational strategies, interprets clinical and translational data, contributes to regulatory filings, and presents results to internal and external audiences.

The role leads, coaches, and mentors a team of medical directors and clinical scientists, while working with research, clinical, medical, scientific, statistical, commercial, regulatory, manufacturing, and operations partners. The position is hybrid, with at least two on-site days per week and remote work available on other days. For candidates at the Stevenage site, the role will temporarily be based there; GSK plans to relocate its offices to Cambridge, UK, with the move currently proposed by early 2029. The stated US annual base salary range for candidates based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA is $284,250–$473,750. The position also offers an annual bonus and eligibility for a share-based long-term incentive program, with benefits including health care and other insurance, retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

Requirements

• MD or equivalent medical degree.
• Clinical and research experience in lung cancer.
• Documented experience as a physician scientist in the pharmaceutical industry or an academic oncology setting, including experience in oncology early-phase clinical trials and translational research.
• Experience interpreting preclinical data packages and providing clinical recommendations on indication and patient selection.
• Experience designing and executing early-phase clinical studies, including first-in-human and proof-of-concept trials.
• Experience with lung cancer treatment guidelines, therapeutic competitive landscape, clinical development processes, and drug approval processes in major regions.
• Experience developing and driving translational strategy, including biomarkers, companion diagnostics, and PK/PD modeling and simulation.
• Experience managing direct reports and leading matrix teams.
• Global regulatory experience.

Nice To Haves

• MD or equivalent medical degree with a PhD, preferably in biological sciences or quantitative/computer science, with documented application toward biomedical work.

Responsibilities

• Lead clinical development plans for a portfolio of early-phase (Phase I/II) protocols, including first-in-human, dose-escalation/expansion, and proof-of-concept studies.
• Be accountable for overall benefit-risk assessments of clinical programs and drive end-to-end clinical development strategy aligned with target medicine profiles and integrated evidence plans.
• Lead clinical development discussions and teams at regulatory interactions, and draft clinical components of regulatory submissions and files, including briefing documents, presentations, and responses to questions.
• Participate as a core member of Early Development Teams and provide clinical development accountability at program level, collaborating with Medical Affairs, Integrated Evidence, Publications, and Global and Regional Commercial functions.
• Ensure clinical studies comply with applicable regulatory requirements, Good Clinical Practice guidelines, and GSK policies and procedures.
• Lead cross-functional Early Clinical Matrix Teams, providing clinical leadership, oncology clinical development expertise, and customer insight.
• Oversee clinical development components of translational science strategies in partnership with early development leaders, translational science, preclinical research, AI/ML, clinical pharmacology, experimental medicine, and research technology teams.
• Partner with Oncology Tumor Teams to develop translational strategies across assets and support tumor-team activities with clinical and translational expertise.
• Drive advancements in translational research and emerging technologies to improve study designs and encourage innovation.
• Interpret complex translational and clinical data, identify trends for clinical and regulatory documents, consult on safety analyses, and respond to health authority queries.
• Author or review abstracts, presentations, and manuscripts for accuracy of clinical data, interpretation, and content.
• Prepare for and lead governance discussions with cross-functional early-development or medicine-development teams and other business lines.
• Lead preparation of clinical sections of regulatory filings, including INDs, study reports, NDAs, and annual reports.
• Provide clinical leadership and support for investigator and consultant meetings, such as investigator meetings and clinical advisory boards.
• Present study results and translational insights to internal and external stakeholders, including senior management, scientific advisory boards, and regulatory agencies.
• Integrate input across research, clinical, medical, scientific, statistical, commercial, regulatory, manufacturing, and operations disciplines to align and execute translational research initiatives.
• Build and maintain relationships with key external experts, academic collaborators, and external research organizations, including the Oncology Translational Network.
• Collaborate with Principal Investigators and Steering Committees in evaluating and assessing publications associated with clinical data.
• Serve as a program medical expert for internal and external collaborators, investigators, and consultants.
• Lead, coach, and mentor Oncology Early Clinical Development Medical Directors and Clinical Scientists, providing ongoing development and leadership through regular meetings and check-ins.
• Guide direct reports in cross-functional integration, coordination, collaboration, and alignment for effective execution of clinical development plans and translational strategies.
• Foster the team culture and contribute to standards for clinical documents and data-review processes across Oncology Clinical Development.

Benefits

• Annual bonus.
• Eligibility to participate in a share-based long-term incentive program, dependent on role level.
• Health care and other insurance benefits for employees and families.
• Retirement benefits.
• Paid holidays.
• Vacation.
• Paid caregiver, parental, and medical leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree