GSK

VP, Medicine Development Leader

GSK

full-time

Posted on:

Location Type: Hybrid

Location: Waltham • Massachusetts • Pennsylvania • United States

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Salary

💰 $242,250 - $403,750 per year

Job Level

Senior

About the role

  • 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: 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
  • 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 results
  • Ensure excellence in execution of all governance processes, including MDT members, 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 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

Requirements

  • 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 in the healthcare environment, and access in all major markets
Benefits
  • health care and other insurance benefits (for employee and family)
  • retirement benefits
  • paid holidays
  • vacation
  • paid caregiver/parental and medical leave
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
drug developmentclinical trial managementregulatory compliancebudget planningBLA submissionNDA submissionMAA submissionlife cycle managementclinical feasibilityrisk mitigation
Soft Skills
leadershipteam managementstakeholder engagementstrategic planningcommunicationperformance managementnegotiationpatient focusorganizational reputationcross-functional collaboration
Certifications
MDPhDPharmDMBAMS