VP, Medicine Development Leader - Respiratory
About the role
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 work 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 the first major market(s).
Post-approval, you will 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) in the major markets.
You will 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, including options for acceleration, parallel indication development and smart risk-taking.
You will 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 including but not limited to clinical feasibility, regulatory planning and CMC risk mitigation.
You will lead 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.
You will prioritize and maximize the asset’s development options including developing multiple indications.
You will partner with the Global Medical Lead (GML) and MCL to develop an indication expansion and LCM plan for the asset.
You will make clear evidence-based go / no go / accelerate decisions and identify clear inflection points, based on whether the results fulfill the strategy set out for the medicine.
You will enhance patient focus by incorporating the voice of the patient into development plans.
You will 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.
You will 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, as needed, e.g., Chief Scientific Officer, TA Head, Chief Medical Officer, TA Development Review Board and Portfolio Investment Board.
You will 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, working closely with the PPM and Finance Partner to do so.
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 the first major market(s)
- Providing 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
- Partnering with the Pipeline Project Manager (PPM), energizing and motivating 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
- Partnering 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
- Leading 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
- Prioritizing and maximizing the asset’s development options including developing multiple indications
- Partnering with the Global Medical Lead (GML) and MCL to develop an indication expansion and LCM plan for the asset
- Making clear evidence-based go / no go / accelerate decisions and identifying clear inflection points, based on whether the results fulfill the strategy set out for the medicine
- Increasing patient focus by incorporating the voice of the patient into development plans
- Increasing 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
- Serving 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
- Delivering and managing 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
Requirements
- Advanced degree including MD, PhD, PharmD, MBA, MSDrug 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
Qualifications
- Advanced degree including MD, PhD, PharmD, MBA, MSDrug 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
Skills
- Strategic thinking and ability to translate strategy into actionable plans
- Collaborative and motivational leadership skills
- Strong communication and stakeholder management skills
- Ability to work effectively in a matrixed, global and multi-disciplinary organization
- Experience in managing budgets and leading strategic planning
- Understanding of regulatory requirements and frameworks
- Experience in managing cross-functional teams
- Experience in managing clinical trials and post-approval studies
- Experience in managing medical and commercial aspects of drug development
- Experience in managing patient-focused development plans
- Experience in managing external relationships and increasing visibility
- Experience in managing budgets and leading strategic planning
- Experience in managing patient-focused development plans
- Experience in managing external relationships and increasing visibility
- Experience in managing budgets and leading strategic planning
- Experience in managing patient-focused development plans
- Experience in managing external relationships and increasing visibility
- Experience in managing budgets and leading strategic planning
- Experience in managing patient-focused development plans
- Experience in managing external relationships and increasing visibility
- Experience in managing budgets and leading strategic planning
- Experience in managing patient-focused development plans
- Experience in managing external relationships and increasing visibility
- Experience in managing budgets and leading strategic planning
- Experience in managing patient-focused development plans
- Experience in managing external relationships and increasing visibility
- Experience in managing budgets and leading strategic planning
- Experience in managing patient-focused development plans
- Experience in managing external relationships and increasing visibility
- Experience in managing budgets and leading strategic planning
- Experience in managing patient-focused development plans
- Experience in managing external relationships and increasing visibility
- Experience in managing budgets and leading strategic planning
- Experience in managing patient-focused development plans
- Experience in managing external relationships and increasing visibility
- Experience in managing budgets and leading strategic planning
- Experience in managing patient-focused development plans
- Experience in managing external relationships and increasing visibility
- Experience in managing budgets and leading strategic planning
- Experience in managing patient-focused development plans
- Experience in managing external relationships and increasing visibility
- Experience in managing budgets and leading strategic planning
- Experience in managing patient-focused development plans
- Experience in managing external relationships and increasing visibility
- Experience in managing budgets and leading strategic planning
- Experience in managing patient-focused development plans
- Experience in managing external relationships and increasing visibility
- Experience in managing budgets and leading strategic planning
- Experience in managing patient-focused development plans
- Experience in managing external relationships and increasing visibility
- Experience in managing budgets and leading strategic planning
- Experience in managing patient-focused development plans
- Experience in managing external relationships and increasing visibility
- Experience in managing budgets and leading strategic planning
- Experience in managing patient-focused development plans
- Experience in managing external relationships and increasing visibility
- Experience in managing budgets and leading strategic planning
- Experience in managing patient-focused development plans
- Experience in managing external relationships and increasing visibility
- Experience in managing budgets and leading strategic planning
- Experience in managing patient-focused development plans
- Experience in managing external relationships and increasing visibility
- Experience in managing budgets and leading strategic planning
- Experience in managing patient-focused development plans
- Experience in managing external relationships and increasing visibility
- Experience in managing budgets and leading strategic planning
- Experience in managing patient-focused development plans
- Experience in managing external relationships and increasing visibility
- Experience in managing budgets and leading strategic planning
- Experience in managing patient-focused development plans