VP Medicine Development Leader- Oncology

GSK

37d•Hybrid

About The Position

The VP Medicine Development Leader (MDL) is to strategically lead the optimal global development of a medicine, acting as the single point of accountability for the medicine from C2P2 to approval in first major market, but substantially contributing and influencing from pre-C2P2 to post-launch life-cycle management, to ultimately deliver differentiated medicines of value. By working with the various stakeholders across R&D and Pharma, the MDL defines the strategic vision and operational plan for the medicine, aligning it with the overall organizational strategy. The VP MDL creates and leads the matrix Medicine Development Team (MDT), which has responsibility for representing all the various R&D and commercial disciplines required to optimally deliver the development of the medicine (including clinical development, medical affairs, safety, regulatory, commercial and product development and manufacturing, amongst others). Please note: This position requires an on-site office -based presence 2 to 3 days a week in the UK (London or Stevenage) or US (Collegeville/Upper Providence, PA or Waltham. MA)

Requirements

Advanced degree in a clinical or scientific discipline (MD, PhD, PharmD or equivalent)
Filing experience BLA/NDA/ MAA submissions as a core responsibility and have led development programs.
Must demonstrate extensive broad drug development expertise and experience
Executive level pharmaceutical industry experience
Prior significant experience in leading successful development and registration of medicines
Deep experience in product development and/or commercial, especially in late phase Oncology development (from PoC onwards), clinical trial management with significant operational complexity, post-approval studies, regulatory and manufacturing compliance
Highly developed ethics and integrity, with demonstrated ethical medical decision-making skills.
Understands the entirety of R&D across the development/commercial life cycle to allow impact across all functions: discovery, late stage development, regulatory, manufacturing and commercial.
Track record of success working in highly 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 an understanding of the legal and government frameworks within and across global geographies.
Strong people management, leadership and motivational skills
In-depth experience creating the strategy for pre- and post-marketing studies, and driving the lifecycle process
Ability to work collaboratively and successfully across functions – research, commercial, regulatory, global medicine supply, legal, regions etc.
Ability to build relationships and create authentic alignment while leading high performing teams in a collaborative and purposeful manner to achieve defined objectives
Must be able to clearly demonstrate a thorough understanding of the healthcare environment including all key external stakeholder

Nice To Haves

Business acumen and experience of managing a sizable P&L which has organizational impact. Experience of building budgets and then leading the strategic and budget planning process
Track record of leading with high operational complexity. Including global, geographically dispersed teams, multi-disciplinary structures with high accountability, minimal authority, and multiple lines of reporting

Responsibilities

Act as a single point of accountability in GSK for all aspects of a medicine in development globally from C2P2 to approval in first major markets.
In addition to the overall leadership role, the MDL should provide key support to the Early Development Team (EDT) leading up to C2P2 to ensure smooth transfer of accountability and a successful C2P2 and transition from phase 1 to phase 2.
In addition to the overall leadership role, the MDL should provide key support to the Medicines Commercialisation Team post-approval in first major markets ensuring that the MDT provide optimal support to both registration and lifecycle management.
Selects members of the MDT, in consultation with the line leaders, and leads this multi-disciplinary matrix team; supports differentiated development for team members; owns the performance of MDT and partners with line managers to drive performance
Establishes a compelling vision for the medicine; positions the medicine within the R&D strategy taking the competitive landscape into account; Translate GSK’s strategy into asset strategy and actionable plans for multiple areas or functions.
Delivers differentiated medicines of value for patients, stakeholders and markets, through an evidence package that supports regulatory approval, market access, and product life cycle.
Delivers the Medicine Development Strategy that is aligned with the R&D disease strategy, as well as the asset Medicine Vision and Medicine Profile.
Prioritizes and maximizes the asset’s portfolio options including developing multiple indications. Makes clear evidence-based go / no go / accelerate decisions, based on whether the results fulfil the strategy set out for the medicine, and identify clear inflection points
Embeds core processes including cost efficiency, adoption of new technology, risk identification & management, compliance with policy
Identifies and aligns resources (people and financial), team objectives and strategies behind the vision to ensure successful project completion
Proactively identifies unmet medical needs that could be addressed through line extensions
Enhances patient focus by incorporating the voice of the patient into development plans.
Promotes organizational reputation and drives asset value by engaging and negotiating with internal and external stakeholders
Collaborates with other stakeholders but in particular EDLs and other MDLs to create strategies that support organizational vision; shares optimal ways of working and knowledge
Ensures quality & compliance oversight in line with R&D expectations and project needs; assures quality of data and science
Prioritizes and manages asset portfolio options to meet budget constraints.
Model Values and Leadership Expectations internally and externally
Asset single point of contact and spokesperson to senior management and senior boards (e.g., Chief Scientific Officer, Head of Development, Chief Medical Officer, President of Pharma, Development Review Board and Portfolio Investment Board) and other relevant internal governance committees and external Advisory Committees as needed.
Increases visibility amongst the external communities (physicians, regulators, patients, payers), to bring medical solutions to patients with unmet medical needs, thereby enhancing reputation of GSK.
MDL serves as the single accountable decision maker to resolve disputes among the MDT. The MDL should discuss any team misalignment/disputes with the Head of Development prior to rending a final decision.
MDL is accountable for delivering and managing the asset resourcing plan. In addition, the MDL is accountable for managing the asset budget to the agreed variance.
MDL is accountable for developing an ongoing patent strategy for the asset
Partners with Business Development to facilitate diligence reviews, product positioning and/or alternative business strategies (e.g., public private partnerships, co-development) and internal review and decision-making processes in line with GSK governance procedures as well as use of appropriate alliance management mechanisms to ensure successful business transactions and relationships.