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Executive Medical Director, Early Clinical Development Lead – Oncology – Lung & Head/Neck Cancers
GSK. Create a strong link between Clinical Development and pre-clinical/discovery teams to improve forward and reverse translation .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in designing and executing early-phase clinical studies, particularly in oncology, while ensuring compliance with regulatory requirements and driving translational strategies. Proven ability to lead cross-functional teams and manage clinical development plans effectively.
Highest-signal resume keywords
Oncology Early-Phase Clinical TrialsClinical Data InterpretationTranslational Research StrategyGlobal Regulatory ExperienceMatrix Leadership
ATS Keywords
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Hard Skills
Clinical Trial DesignClinical Trials MonitoringDrug DevelopmentEvidence Based Decision MakingPK/PD Modeling and SimulationFirst-In-Human StudiesProof-Of-Concept TrialsLung Cancer Treatment GuidelinesClinical Development ProcessDrug Approval Process
Soft Skills
Executive PresenceLearning AgilityCoaching and MentoringBuilding RelationshipsFostering Culture
Tools & Technologies
Digital FluencyClinical Data Review Processes
Certifications & Qualifications
MD or Equivalent Medical DegreePhD in Biological Sciences or Quantitative/Computer Science (Preferred)
Industry Keywords
Hematology and OncologyTranslational ScienceRegulatory AffairsReal World Evidence (RWE)Clinical Accountability
About the role
Key responsibilities & impact- Create a strong link between Clinical Development and pre-clinical/discovery teams to improve forward and reverse translation
- Lead a team of Oncology Early Clinical Development Medical Directors and Clinical Scientists
- Design and execute early-phase Phase I/II clinical studies, including first-in-human, dose-escalation/expansion, and proof-of-concept studies
- Own clinical development plans for a portfolio of early-phase protocols
- Manage overall benefit-risk of clinical programs
- Drive end-to-end clinical development strategy aligned to target medicine profiles and integrated evidence plans
- Lead clinical development discussions and teams during regulatory interactions
- Draft clinical components of IND, NDA, BLA, and MAA submissions
- Participate as a core member of Early Development Teams and provide program-level clinical accountability
- Ensure clinical studies comply with regulatory requirements, GCP guidelines, and GSK policies
- Lead cross-functional Early Clinical Matrix Teams
- Oversee clinical components of translational science strategies
- Partner with Oncology Early Development Leaders, Translational Science, pre-clinical research, AI/ML, Clinical Pharmacology, Experimental Medicine, and Research Technologies teams
- Develop translational strategies with Oncology Tumor Teams
- Advance translational research and emerging technologies
- Interpret complex translational and clinical data and consult on safety analyses and health authority responses
- Author and review abstracts, presentations, and manuscripts
- Lead governance discussions and regulatory filing preparation
- Lead investigator, consultant, and clinical advisory board meetings
- Present study results and translational insights to internal and external stakeholders
- Integrate cross-functional inputs across research, clinical, medical, scientific, statistical, commercial, regulatory, manufacturing, and operations disciplines
- Build relationships with key external experts, academic collaborators, and external research organizations
- Collaborate with Principal Investigators and Steering Committees on clinical-data publications
- Serve as program medical expert for collaborators, investigators, and consultants
- Coach and mentor Oncology Early Clinical Development Medical Directors and Clinical Scientists
- Hold regular staff meetings, check-ins, and one-to-one meetings
- Guide direct reports on cross-functional integration and execution
- Foster the OneOncology culture
- Contribute to standards for clinical documents and data-review processes
Requirements
What you’ll need- MD or equivalent medical degree required
- Clinical and research experience in lung cancer
- Documented experience as a physician scientist in the pharmaceutical industry or an academic oncology setting
- Experience in oncology early-phase clinical trials and translational research
- Experience interpreting pre-clinical data packages and providing clinical recommendations on indication and patient selection
- Experience designing and executing early-phase clinical studies, including FTIH and POC trials
- Experience with lung cancer treatment guidelines, therapeutic competitive landscape, clinical development process, and drug approval process 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
- Preferred: MD or equivalent medical degree with PhD, preferably in biological sciences or quantitative/computer science, with documented application toward biomedical
- Clinical Data Interpretation
- Clinical Trial Designs
- Clinical Trials Monitoring
- Digital Fluency
- Drug Development
- Drug Regulatory Affairs
- Evidence Based Decision Making
- Executive Presence
- Hematology and Oncology
- Learning Agility
- Matrix Leadership
- Real World Evidence (RWE)
- Scientific Presentations
- Strategic Direction
Benefits
Comp & perks- Annual bonus
- Eligibility to participate in share-based long-term incentive program
- Health care and other insurance benefits for employee and family
- Retirement benefits
- Paid holidays
- Vacation
- Paid caregiver/parental and medical leave
- Hybrid work arrangement with remote work available on non-site days
- Accommodation or other assistance to apply, where required