Vice President - Medicines Development Leader (Oncology R & D)
Site Name: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: Aug 30 2021 Have you built experiences in/outside of oncology clinical development that has you poised to be accountable for all non-marketing global product activities at an asset level for medicines from Commit to Phase 2 to post-launch LCM? If so, this VP level career opportunity may be for you. GSK continues to expand the Oncology Clinical Development organization with a commitment to the discovery and development of new oncology therapies with the life-changing potential of helping patients with cancer, specifically in four areas of cancer research: • Immuno-Oncology: using the human immune system to treat cancer • Cell/Gene Therapy: engineering human T-cells to target cancer • Cancer Epigenetics: modulating the gene-regulatory system of the epigenome to exert anti-cancer effects • Synthetic Lethality: targeting two mechanisms at the same time which together, but not alone, have substantial effects against cancer For more information on these areas of focus, read GSK's: https://us.gsk.com/en-us/careers/a-career-in-oncology/ GSK 2020 Annual Report: https://www.gsk.com/en-gb/investors/corporate-reporting/annual-report-2020/ THE MDL ROLE: The core purpose of the Medicines 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 VP MDL reports to the SVP MDLs. MDL's accountability and key responsibilities include but are not limited to: 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. Works closely with the EDL and MCL to ensure a smooth transition between the EDL (accountable from Candidate Selection to Proof of Concept, Phase 1) to MDL (accountable from Phase 2 to approval in first major market) and from MDL to MCL (accountable from approval in first major market). In addition to the overall leadership role, the MDL should provide key support to the 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 MCT post-approval in first major markets ensuring that the MDT provide optimal support to both registration and LCM. Selects members of the Medicines Development Team (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 Energizes and motivates the MDT 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. Ensures excellence in execution of all governance processes, including oversight of all studies, pharmacovigilance, scientific engagement and promotional practices. 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 MDL's Drivers: You are a talented and experienced leader motivated by the desire to make a difference in patients' lives. You are excited by challenging goals and positively impacting the progression of medicines of value to patients that provide the adequate return to the business. You have a proven ability to think and plan uniquely and strategically, to work with members of other functions within a matrix environment. You are Intrigued by innovation, creativity and new opportunities to learn You are energized by delivering high standards through collaboration and motivating others across the organization You are passionate about developing others into future leaders You are committed to maintaining the highest compliance standards *LI-GSK Additional Responsibilities Scientific Engagement Accountable for global oversight, coordination, and approval of scientific engagement activities pre-authorization. Secures advice to inform the development of products of value, for the benefit of patients and consumers. Identifies and engages the external community appropriately in robust scientific dialogue that generates insight and advances scientific and medical understanding. Ensures timely and appropriate interaction and exchange of information between GSK and external communities (e.g., patients, physicians, payers, regulators), in strict adherence with GSK Policies, and GSK Global Scientific Engagement Principles and Standards. Ensures balanced and robust scientific communications in all formats. Lifecycle Management Proactively identifies unmet needs that could be addressed through line extensions e.g. novel indications, combinations or formulations, or the provision of enhanced services. Anticipates the changing healthcare, regulatory & competitive environment throughout the product lifespan; defines and delivers innovative strategies and plans to inform evidence-based prescribing/ usage within this environment e.g. new comparator or real-world efficacy data. Understands the impact of new data on the value/positioning of products in guidelines/formularies. Business Development 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. Why you? Qualifications: We are seeking a professional with the following qualifications and skills to achieve our goals: Minimum Qualifications: Advanced degree such as MD, PhD or PharmD or equivalent is highly preferable Filing experience BLA/NDA/ MAA submissions as a core responsibility and have led development programs. Must demonstrate extensive broad drug development expertise and experience At least 7 years 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 Preferred qualifications: 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 Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox. Managing individual performance. Creating a performance culture and driving results, prioritisation, execution, delivering performance. Setting strategic direction and leading on-going organisational transformation. Building a resilient organisation. Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit. Managing P&L and capital allocation. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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. 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