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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in oncology drug development, including regulatory submissions and lifecycle management, while leading cross-functional teams in a complex global environment. Proven ability to create strategic visions and operational plans that align with organizational goals.
Highest-signal resume keywords
Oncology Drug Development ExperienceBLA/NDA/MAA Submission ExperienceMatrix Leadership SkillsRegulatory Compliance KnowledgeBudget Planning and Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ManagementRegulatory Strategy DevelopmentLifecycle ManagementEvidence Package DevelopmentOncology Product CommercializationClinical Feasibility AssessmentRisk Mitigation PlanningPost-Marketing StudiesPatient Safety OversightPharmacovigilance
Soft Skills
Strong Ethical Decision-MakingCollaborative Team LeadershipMotivational SkillsCommunication SkillsStakeholder Engagement
Certifications & Qualifications
Advanced Degree (MD, PhD, PharmD, MBA, or MS)
Industry Keywords
Global Pharmaceutical IndustryBiotechnology IndustryOncologyRegulatory RequirementsHealthcare EnvironmentGastrointestinal CancersPancreatic CancersClinical DevelopmentCommercial Life CycleGovernance Excellence
About the role
Key responsibilities & impact- Lead the optimal global development of a medicine at asset level from clinical Proof of Concept to approval in the first major market(s)
- Act as the single point of accountability for all aspects of the medicine being developed globally
- Define the strategic vision and operational plan for the medicine in alignment with organizational strategy
- Create and lead the matrixed Medicine Development Team across Clinical Development, Medical, Commercial, Manufacturing, and other disciplines
- Coordinate transition of lead indications from the Early Development Lead after clinical PoC and to the Medicine Commercial Lead upon approval
- Support post-approval registration, Post-Marketing Requirements, and lifecycle management in major markets
- Select Medicine Development Team members with functional line heads and own team performance
- Partner with the Pipeline Project Manager to drive operational delivery, acceleration options, parallel indication development, and risk-taking
- Lead development planning for prospective in-licensed assets, including clinical feasibility, regulatory planning, and CMC risk mitigation
- Establish the medicine vision and profile, incorporating competitive landscape and GSK strategy
- Deliver differentiated medicines and evidence packages supporting regulatory approval, market access, and product lifecycle
- Prioritize development options and develop multiple indications
- Partner with Global Medical and Medicine Commercial Leads on indication expansion and lifecycle management
- Make evidence-based go/no-go and accelerate decisions
- Ensure governance excellence across clinical studies, patient safety, pharmacovigilance, scientific engagement, and promotional practices
- Incorporate patient voice into development plans
- Increase visibility among physicians, regulators, patients, and payers
- Serve as asset spokesperson to senior management, governance committees, and external advisory committees
- Manage asset resourcing, people, finances, and budget variance with the Pipeline Project Manager and Finance Partner
Requirements
What you’ll need- Advanced degree including MD, PhD, PharmD, MBA, or MS
- Oncology drug development experience within the global pharmaceutical and/or biotechnology industry
- Filing experience with BLA/NDA/MAA submissions as a core responsibility
- Experience across the entirety of oncology drug development across the R&D/commercial life cycle, including Discovery, late-stage Development, Regulatory, Manufacturing, Medical, and Commercial
- Experience in oncology product development and/or commercialization, late phase development from clinical PoC onwards, clinical trial management, post-approval studies, regulatory and manufacturing compliance
- Experience leading teams in a complex, matrixed, global, and multi-disciplinary organization with high accountability, minimal authority, and multiple lines of reporting
- Experience working with regulators and regulatory requirements, including legal and government frameworks within and across global geographies
- Experience creating the strategy for pre- and post-marketing studies and driving the lifecycle process
- Experience building budgets and leading the strategic and budget planning process
- Experience in the healthcare environment and access in all major markets
- Experience leading oncology drug development programs in gastrointestinal (GI) or pancreatic cancers is preferred
- Highly developed ethics and integrity, with demonstrated ethical medical decision-making skills
- Strong matrix leadership and motivational skills
- Ability to work collaboratively across Research, Commercial, Regulatory, Global Medicine Supply, Legal, and regional functions
- Required on-site presence at least two days per week at a GSK US, Switzerland, or UK site
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
- Accommodation or other assistance to apply, if required