Medicine Development Leader-Cancer Vaccines - Oncology Research Unit

For candidates seeking to be located at our Stevenage site, this role will temporarily be based at Stevenage. However, the Company plans to relocate its offices to Cambridge, UK. The location of this role will therefore subsequently change to Cambridge, UK in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029.

Reporting to the SVP Oncology Product Leadership, the VP, Medicine Development Leader (MDL) – Cancer Vaccines will strategically lead the optimal global development of GSK's cancer vaccine medicine(s), acting as the single point of accountability for the asset from C2P2 (or the equivalent stage for oncology) through approval and launch of all indications in major markets, as well as supporting approval and launch in tier 2/3 countries.

By working with the various stakeholders across R&D and Pharma, the VP, MDL – Cancer Vaccines defines the strategic vision and operational plan for the cancer vaccine medicine, aligning it with GSK's overall oncology and immuno-oncology strategy. The VP, MDL – Cancer Vaccines will create and lead the matrix Medicine Development Team (MDT), which is responsible for representing all the R&D and commercial disciplines required to optimally deliver development of the cancer vaccine, including clinical development, translational medicine/immune monitoring, medical affairs, safety, regulatory, commercial, and product development and manufacturing (including vaccine platform/manufacturing partners), amongst others.

This position is offered as a hybrid position with a required on-site presence of at least two days per week at one of GSK’s US (PA or MA), UK (London - New Oxford Street or Stevenage) or Switzerland (Zug) sites.

In this role you will:

• Act as GSK's single point of accountability for the global development of a cancer vaccine asset from C2P2 (or the oncology equivalent stage) through approval and launch across all indications in major markets, including support for approval and launch in tier 2/3 countries.
• Provide key support to the Early Development Team (EDT) leading up to late-stage transition for the cancer vaccine program, ensuring smooth transfer of accountability and successful execution, including transition of neoantigen/antigen-selection and immunogenicity data packages.
• Provide key support to the Medicines Commercialisation Team post-approval in first major markets, ensuring the MDT delivers optimal support to registration and lifecycle management for the cancer vaccine, including combination strategies with checkpoint inhibitors or other immuno-oncology agents.
• Build the Medicine Development Team (MDT) and lead this multi-disciplinary matrix team spanning clinical development, immunology/biomarkers, manufacturing (including personalized/off-the-shelf vaccine platforms), regulatory, safety, medical affairs and commercial; supports differentiated development of team members and own MDT performance in partnership with line managers.
• Establish a compelling vision for the cancer vaccine within GSK's Oncology R&D strategy, accounting for the competitive immuno-oncology and cancer vaccine landscape, and translates GSK's strategy into actionable asset plans across functions.
• Deliver differentiated cancer vaccine medicines of value for patients, stakeholders and markets through an evidence package (including immunogenicity, biomarker and clinical efficacy data) that supports regulatory approval, market access and product lifecycle.
• Deliver the Medicine Development Strategy aligned with GSK's oncology disease strategy, the asset Medicine Vision and the Medicine Profile for the cancer vaccine program.
• Prioritize and maximize the asset's portfolio options, including developing multiple tumor-type indications and combination regimens; makes clear, evidence-based go/no-go/accelerate decisions against the strategy and identifies clear inflection points (e.g., immunogenicity readouts, interim efficacy analyses).
• Embed core processes including cost efficiency, adoption of new vaccine platform technology (e.g., mRNA, neoantigen prediction, personalized vaccine manufacturing), risk identification and management, and compliance with policy.
• Identify and align resources (people and financial), team objectives and strategies behind the vision to ensure successful completion of the cancer vaccine development program.
• Proactively identify unmet medical needs in oncology that could be addressed through new indications or line extensions of the cancer vaccine platform.
• Enhance patient focus by incorporating the voice of the patient into cancer vaccine development plans.
• Promote organizational reputation and drives asset value by engaging and negotiating with internal and external stakeholders, including academic and biotech collaborators in the cancer vaccine space.
• Collaborate with other stakeholders, in particular EDLs and other MDLs, to create strategies that support the organizational vision; shares optimal ways of working and knowledge across the oncology and vaccines portfolios.
• Ensure quality and compliance oversight in line with R&D expectations and project needs; assures the quality of data and science underpinning the cancer vaccine program.
• Serves as the asset's 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 among external communities (physicians, regulators, patients, payers) to bring cancer vaccine solutions to patients with unmet medical needs, thereby enhancing GSK's reputation.
• Accountable for delivering and managing the asset resourcing plan, and for managing the asset budget to the agreed variance.
• Accountable for developing an ongoing patent strategy for the cancer vaccine asset.
• Partner with Business Development to facilitate diligence reviews, product positioning and/or alternative business strategies (e.g., public-private partnerships, co-development) relevant to the cancer vaccine space, and internal review and decision-making processes in line with GSK governance procedures, using appropriate alliance management mechanisms to ensure successful business transactions and relationships.

Basic Qualifications:

• Advanced degree including MD, PhD, PharmD, MBA, MS
• Oncology drug development expertise in the global pharmaceutical/biotechnology industry
• Experience leading successful development and registration of medicines; experience with cancer vaccines, therapeutic vaccines, or immuno-oncology combination products
• Filing experience with BLA/NDA/MAA submissions as a core responsibility

• Experience in R&D across the development/commercial life cycle to allow impact across all functions: discovery, late-stage development, regulatory, manufacturing and commercial.

• 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, and 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 related to novel vaccine and immune-oncology modalities

• Experience creating the strategy for pre- and post-marketing studies and driving the lifecycle process for complex biologic or vaccine assets.

• Experience managing P&L, building budgets and leading the strategic and budget planning process

Preferred Qualifications:

• Experience with personalized medicine or novel vaccine manufacturing platforms (e.g., mRNA, neoantigen-based)
• Familiarity with the scientific principles of tumor immunology, antigen selection/neoantigen prediction, and immune monitoring/biomarker strategies is highly desirable.
• Deep scientific credibility in tumor immunology and cancer vaccine science sufficient to engage with KOLs, regulators and internal R&D leadership on complex immunogenicity and mechanism-of-action questions.
• Comfort operating at the intersection of novel vaccine platform technology and traditional oncology drug development, including combination strategies with checkpoint inhibitors and other immunotherapies.
• 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.

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Skills

Business Acumen, Clinical Data Interpretation, Clinical Pharmacology, Clinical Trial Designs, Digital Fluency, Drug Development, Drug Regulatory Affairs, Evidence Based Decision Making, Executive Presence, Hematology and Oncology, Innovative Leadership, Learning Agility, Real World Evidence (RWE), Scientific Presentations, Strategic Direction• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $340,500 to $567,500. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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