VP, Medicine Development Leader, Oncology - GI

GSK plc; Pennsylvania; Hybrid; USD 266,000 - 444,000; Full time

Benefits offered by this job

Health care and other insurance

Retirement benefits

Paid holidays and vacation

Job summary

GSK plc seeks a Vice President Medicine Development Leader (MDL) - Oncology to strategically lead global development from PoC to first major market approvals. You will chair the Medicine Development Team, aligning Clinical Development, Medical, Regulatory, Manufacturing and Commercial functions to deliver an asset strategy.

The role is hybrid with on-site presence at least two days per week at US/UK sites, requiring proven oncology drug development leadership, budget stewardship and

Qualifications

• Advanced degree in a relevant field (MD/PhD/PharmD/MBA/MS).
• Oncology drug development experience in global pharma/biotech.
• Experience leading matrix teams with high accountability.
• Filing experience with BLA/NDA/MAA submissions.
• Experience shaping development strategy and lifecycle planning.

Responsibilities

• Act as single accountable lead for a medicine from PoC to first major market approvals.
• Lead MDT with Clinical Development, Medical, Regulatory, Manufacturing and Commercial.
• Drive development planning, risk mitigation and resource allocation.
• Partner with GML, MCL and PPM to deliver timelines and budgets.
• Provide governance, oversight of studies and pharmacovigilance.

Skills

Business Strategies

Collaborative Partnerships

Commercial Acumen

Digital Fluency

Drug Development

Drug Regulatory Affairs

Evidence Based Decision Making

Executive Presence

Hematology and Oncology

Innovative Leadership

Matrix Leadership

Prioritization

Scientific Data Analysis

Scientific Presentations

Team Development

Education

Advanced degree including MD, PhD, PharmD, MBA, MS

Job description

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 .

As VP Medicine Development Leader (MDL) - Oncology, 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.

Accountability and key responsibilities include but are not limited to:

• 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

This position is offered as a hybrid position with a required on-site presence at least two days per week at one of GSK’s US (Waltham, MA or Upper Providence, PA), Switzerland (Zug) or UK (GSK HQ or Stevenage/Cambridge) sites.

Why You?

Basic Qualifications

• Advanced degree including MD, PhD, PharmD, MBA, MS
• Oncology drug development experience within the global pharmaceutical and/or biotechnology industry
• Filing experience with BLA/NDA/MAA submissions as a core responsibility
• Experience in the entirety of oncology drug development across the R&D/commercial life cycle including Discovery, late-stage Development, Regulatory, Manufacturing, Medical and Commercial
• Experience in oncology 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

Preferred Qualifications

• Experience leading oncology drug development programs in gastrointestinal (GI) or pancreatic cancers is preferred
• 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.

Skills

Business Strategies, Collaborative Partnerships, Commercial Acumen, Digital Fluency, Drug Development, Drug Regulatory Affairs, Evidence Based Decision Making, Executive Presence, Hematology and Oncology, Innovative Leadership, Matrix Leadership, Prioritization, Scientific Data Analysis, Scientific Presentations, Team Development

• 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 $266,250 to $443,750.

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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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.