GSK is seeking a highly skilled VP, Medicine Development Leader (MDL), to strategically lead the optimal global development of a renal 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. The VP MDL reports to the SVP & Head Advanced Pipeline Unit- Respiratory, Immunology and Inflammation Research Unit.
About RIIRU:
The Respiratory, Immunology and Inflammation Research Unit (RIIRU) was formed in 2024 to identify and advance novel molecular targets with genetic associations to disease based on the foundational observation that targets with human genetic evidence supporting their causal role in the intended indication improves clinical success by two-fold. Our core therapeutic areas include Respiratory, Hepatology, Nephrology, Neurodegeneration and Rheumatology. The remit of RIIRU is to identify novel targets based on human genetics, develop assets for clinical studies, and perform trials through to submission for approvals. This goal is enabled through strategic external (e.g., Flagship Pioneering, Vesalius, Muna Therapeutics and others) and GSK-internal partnerships (Research Technologies).
PLEASE NOTE: This career opportunity requires an on-site office presence (minimum of two days a week) in one of GSK's US (PA or MA) or UK (London - New Oxford Street or Stevenage) sites.
Key Responsibilities:
* Act as a single point of accountability in GSK for all aspects of a medicine being developed globally, from proof of clinical activity (POC) to Approval in all major market(s)
* 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 first major market(s)
* Post-approval, 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
* Work with the functional line Heads supporting RIIRU to select MDT members and lead 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
* 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.
* 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
* Leads the cross-functional MDT to:
o Establish a compelling vision for the medicine and Target Medicine Profile (TMP) 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
o 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
o Prioritize and maximize the asset's development options including developing multiple indications
o Partner with the Global Medical Lead (GML) and MCL to develop an indication expansion and LCM plan for the asset.
o Make clear evidence-based go / no go / accelerate decisions and identify clear inflection points, based on results
o Ensure excellence in execution of all governance processes, including MDT members, on oversight of clinical studies, patient safety & pharmacovigilance, scientific engagement and promotional practices
o Enhance patient focus by incorporating the voice of the patient into development plans
o Increase visibility amongst the external communities to bring medical solutions to patients with unmet medical needs
* Embed core processes including cost efficiency, adoption of new technology, risk identification & management, compliance with policy
* Promote organizational reputation and drives asset value by engaging and negotiating with internal and external stakeholders
* Ensures quality & compliance oversight in line with R&D expectations and project needs; ensures quality of data and science
* 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
* 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
Basic Qualifications:
* Advanced degree including MD, PhD, PharmD, MBA, MS
* Drug 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 the healthcare environment, and access in all major markets
Preferred Qualifications:
* 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.
• 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 $242,250 to $403,750.
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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