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About the Role

As VP Medicine Development Leader (MDL), you will strategically lead the optimal global development of a medicine at an asset level, acting as the single point of accountability for the medicine from clinical Proof of Concept (PoC) to Approval in the first major market(s). You will define the strategic vision and operational plan for the medicine, aligning it with the overall organizational strategy and create and lead the matrixed Medicine Development Team (MDT).

Responsibilities

Act as a single point of accountability in GSK for all aspects of a medicine being developed globally, from clinical PoC to Approval in the first major market(s)
Work closely with the Early Development Lead (EDL) and Medicine Commercial Lead (MCL) to ensure a smooth transition of the lead indication(s)
Provide key support to the Medicine Commercial Team (MCT) in the first major markets ensuring the MDT provides optimal support to registration, including Post-Marketing Requirements (PMRs) and life cycle management (LCM)
Select MDT members and lead this multi-disciplinary matrix team, supporting differentiated development for team members, owning the performance of the MDT and partnering with Line Managers to drive performance
Partner with the Pipeline Project Manager (PPM), energize and motivate the MDT to drive a high performing team and operational delivery of the project, including setting team objectives to ensure successful project delivery
Partner with R&D Business Development, leading the development planning for a prospective in-licensed asset by bringing together input from the relevant functions and TA experts to develop a Medicine Profile (MP) and development plans
Establish a compelling vision for the medicine and MP which positions the medicine within the R&D strategy taking the competitive landscape into account
Deliver differentiated medicines of value for patients, stakeholders and markets through an evidence package that supports regulatory approval, market access and the product’s life cycle
Prioritize and maximize the asset’s development options including developing multiple indications
Partner with the Global Medical Lead (GML) and MCL to develop an indication expansion and LCM plan for the asset
Make clear evidence-based go / no go / accelerate decisions and identify clear inflection points
Ensure excellence in execution of all governance processes, including MDT members
Enhance patient focus by incorporating the voice of the patient into development plans
Increase visibility amongst the external communities to bring medical solutions to patients with unmet medical needs
Serve as the asset’s single point of contact and spokesperson to Senior Management, senior boards, other relevant internal governance committees and external Advisory Committees
Deliver and manage the asset resourcing plan (people & finances), including serving as the single point for accountability for managing the asset budget to the agreed variance

Requirements

Advanced degree including MD, PhD, PharmD, MBA, MS
Drug development expertise in the global pharmaceutical/biotechnology industry
Filing experience with BLA/NDA/MAA submissions as a core responsibility
Experience in the entirety of drug development across the R&D/commercial life cycle including Discovery, late-stage Development, Regulatory, Manufacturing, Medical and Commercial
Experience in product development and/or commercialization, in 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 with 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
Highly developed ethics and integrity, with demonstrated ethical medical decision-making skills
Strong matrix leadership and motivational skills
Ability to work collaboratively and successfully across functions – Research, Commercial, Regulatory, Global Medicine Supply, Legal, regions etc.

Skills

Communication
Cross-Functional Leadership
Drug Development
Project Development
Project Implementations
Project Leadership
Scientific Research

Location

Stevenage, UK
Cambridge, UK
US (Waltham, MA or Upper Providence, PA)
GSK HQ

Work Type

Hybrid

Experience Level

Education Level

MD
PhD
PharmD
MBA
MS

Salary/Compensations

$242,250 to $403,750

Benefits

Annual bonus
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

About the Company

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.
We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.
We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines.
We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Equal Opportunity

GSK is an Equal Opportunity Employer. This ensures that 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 (including family medical history), military service or any basis prohibited under federal, state or local law.