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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in drug development and regulatory affairs, with a strong focus on leading multi-disciplinary teams and managing the lifecycle of medicines from clinical proof of concept to market approval. Proven ability to develop strategic plans, manage budgets, and ensure compliance within the global pharmaceutical industry.
Highest-signal resume keywords
Drug Development ExpertiseBLA/NDA/MAA Submission ExperienceMatrix LeadershipClinical Trial ManagementRegulatory Compliance
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 DevelopmentDrug Regulatory AffairsEvidence Based Decision MakingGood Clinical Practice (GCP)Project Management
Soft Skills
Influencing Without AuthorityLearning AgilityPeople ManagementStrategic ThinkingMotivational Skills
Certifications & Qualifications
Advanced Degree (MD, PhD, PharmD, MBA, or MS)
Industry Keywords
Global Pharmaceutical IndustryPost-Marketing RequirementsLifecycle ManagementClinical Trial ManagementHealthcare Environment
About the role
Key responsibilities & impact- Strategically lead the optimal global development of a medicine at asset level from clinical Proof of Concept to approval in the first major markets
- Act as the single point of accountability in GSK for all aspects of the medicine being developed globally
- Work with the Early Development Lead and Medicine Commercial Lead to manage transitions from clinical PoC through approval
- Support the Medicine Commercial Team post-approval in major markets, including registration, Post-Marketing Requirements, and life cycle management
- Select Medicine Development Team members and lead the multi-disciplinary matrix team
- Partner with the Pipeline Project Manager to motivate the team, drive operational delivery, set objectives, and pursue acceleration, parallel indication development, and smart risk-taking
- Partner with R&D Business Development to develop plans for prospective in-licensed assets, including clinical feasibility, regulatory planning, and CMC risk mitigation
- Establish the medicine vision and profile, align asset strategy with GSK’s R&D strategy, and translate strategy into actionable plans
- Deliver differentiated medicines through evidence packages supporting regulatory approval, market access, and product life cycle
- Prioritize development options, including multiple indications
- Develop indication expansion and life cycle management plans
- Make evidence-based go/no-go/accelerate decisions and identify inflection points
- Ensure excellence in governance, clinical study oversight, patient safety and pharmacovigilance, scientific engagement, and promotional practices
- Incorporate the patient voice into development plans
- Increase visibility among physicians, regulators, patients, and payers
- Serve as the asset spokesperson to senior management, boards, governance committees, and external advisory committees
- Deliver and manage the asset resourcing plan, including people, finances, and budget accountability
Requirements
What you’ll need- Advanced degree including MD, PhD, PharmD, MBA, or MS
- Drug development expertise in the global pharmaceutical/biotechnology industry
- Filing experience with BLA/NDA/MAA submissions as a core responsibility
- Experience across the entirety of drug development, including Discovery, late-stage Development, Regulatory, Manufacturing, Medical, and Commercial
- Experience in 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 strategic and budget planning processes
- Experience in the healthcare environment and access in all major markets
- 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 regions
- Clinical Development
- Drug Regulatory Affairs
- Evidence Based Decision Making
- Good Clinical Practice (GCP)
- Influencing Without Authority
- Learning Agility
- People Management
- Project Management
- Scientific Presentations
- Strategic Thinking
Benefits
Comp & perks- Annual bonus
- Eligibility to participate in the 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 for a job