VP, Medicine Development Leader - Respiratory

GSK•Waltham, PA

6d•Hybrid

About The Position

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). By working with the various stakeholders across GSK’s Medicine Development matrix (R&D, Manufacturing, Commercial, etc.), you will define the strategic vision and operational plan for the medicine, aligning it with the overall organizational strategy. You will create and lead the matrixed Medicine Development Team (MDT), which is responsible for representing the various disciplines required to optimally deliver the development of the medicine including Clinical Development, Medical, Commercial and Manufacturing, amongst others.

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

Nice To Haves

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.

Responsibilities

Acting 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)
Working closely with the Early Development Lead (EDL) and Medicine Commercial Lead (MCL) to ensure a smooth transition of the lead indication(s) from the EDL upon achievement of clinical PoC and to the MCL upon Approval in first major market(s)
Post-approval, provides 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) in the major markets
Works with the functional line Heads supporting RIIRU to select MDT members and leads 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
Partners with the Pipeline Project Manager (PPM), energizes and motivates the MDT to drive a high performing team and operational delivery of the project, including setting team objectives to ensure successful project delivery, including options for acceleration, parallel indication development and smart risk-taking.
Partners 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 including but not limited to clinical feasibility, regulatory planning and CMC risk mitigation
Leads the cross-functional MDT to: Establish a compelling vision for the medicine and MP which positions the medicine within the R&D strategy taking the competitive landscape into account, translating GSK’s strategy into asset strategy and actionable plans for multiple areas or functions
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, based on whether the results fulfil the strategy set out for the medicine
Ensure excellence in execution of all governance processes, including MDT members, e.g., the Clinical Development Lead (CDL) partnering with other matrix Leads, such as the Global Regulatory Lead (GRL), the GML, etc. on oversight of clinical studies, patient safety & pharmacovigilance, scientific engagement and promotional practices
Enhance patient focus by incorporating the voice of the patient into development plans
Increase visibility amongst the external communities (physicians, regulators, patients, payers) to bring medical solutions to patients with unmet medical needs, thereby enhancing GSK’s reputation and showcasing our ambition for patients
Serves as the asset’s single point of contact and spokesperson to Senior Management, senior boards, other relevant internal governance committees and external Advisory Committees, as needed, e.g., Chief Scientific Officer, TA Head, Chief Medical Officer, TA Development Review Board and Portfolio Investment Board
Delivers and manages the asset resourcing plan (people & finances), including serving as the single point for accountability for managing the asset budget to the agreed variance, working closely with the PPM and Finance Partner to do so