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VP Medicines Development Leader Oncology


Job Type

Job Function

Science and Technology



On-Site or Remote

Job Type


Competitive salary and benefits

About the Role

*Job description* *Site Name:* Home Worker - GBR, USA - Pennsylvania - Upper Providence *Posted Date:* Jan 26 2024 *PLEASE NOTE: THE POSTING END DATE IS FRIDAY FEBRUARY 2, 2024 at NOON EST. * *R*eporting to the VP- Head of Medicine Development Leaders, the core purpose of 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 Commit to Phase 2 (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 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). The MDL creates a collaborative and open environment within the MDT to maximize potential for innovative ideas to emerge to help solve complex issues. Key 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. Candidate Profile *Basic Qualifications Include:* - Advanced degree - Filing experience BLA/NDA/ MAA submissions as a core responsibility and have led development programs. - Must demonstrate extensive broad drug development expertise and experience - 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 stakeholders - 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 *Preferred Qualifications:* - MD (or international equivalent) , PhD, or PharmD *Why Us?* GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. 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All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. 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