Medicine Development Lead, HIV - ViiV Healthcare

Purpose

As VP, Medicine Development Leader (MDL), 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 ViiV’s Medicine Development matrix (R&D, Commercial, Manufacturing 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.

Responsibilities

• Acting as a single point of accountability in ViiV 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 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
• Leads the cross-functional MDT to:
  • Establish a compelling vision for the medicine within the R&D strategy taking the competitive landscape into account, translating ViiV’s strategy into 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 ViiV’s reputation and showcasing our ambition for patients

• Embeds core processes including cost efficiency, adoption of new technology, risk identification & management, compliance with policy
• Promotes organizational reputation and drives asset value by engaging and negotiating with internal and external stakeholders
• Collaborates with other stakeholders, in particular EDLs and other MDLs, to share knowledge and optimal ways of working
• 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
• 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

Basic Qualifications & Experience:

• MD, PharmD or PhD with a specialism in infectious diseases
• Filing experience with BLA/NDA/MAA submissions as a core responsibility
• Extensive clinical development expertise and industry experience
• Experience in product development and/or commercialization, especially in late phase development (from clinical PoC onwards), clinical trial management, post-approval studies, regulatory and manufacturing compliance
• Highly developed ethics and integrity, with demonstrated ethical medical decision-making skills
• Understanding of the entirety o