VP Medicine Development Leader, Open to flexible working
The role as MDL will be to strategically lead the optimal global development of a medicine, acting as the single point of accountability for the medicine from from pre-Commit to Phase 2 Development (C2P2) to post-launch life-cycle management, ultimately delivering differentiated medicines of value.
By working with the various stakeholders across R&D and Pharma, the MDL will define the strategic vision and operational plan for the medicine, aligning it with the overall organizational strategy.
This is a truly exciting opportunity for an outstanding candidate to lead and drive all aspects of the development of an asset, bringing in and directing expertise from a number of different functions, ensuring its successful outcome and commercial launch. The role will be key in driving the refinement of a promising early pipeline, and by extension the successful growth and development of GSK as a business.
The MDL will create and lead the matrix Medicine Development Team (MDT), which has responsibility for representing all the various R&D and commercial disciplines required to optimally deliver the development of the medicine (including clinical development, medical affairs, safety, regulatory, commercial and product development and manufacturing).
The role reports to Anna Shadman, SVP, Head of MDLs.
M D L Key Responsibilities in Detail
- Act as a single point of accountability in GSK for all aspects of a medicine in development globally from C2P2, to approval in first major markets.
- Works closely with the Early Development Leader and Medicine Commercialization Leader to ensure a smooth transition between the EDL (accountable from Candidate Selection to Proof of Concept, Phase 1) to MDL (accountable from Phase 2 to approval in first major market) and from MDL to MCL (accountable from approval in first major market).
- Provide key support to the EDT leading up to C2P2 to ensure smooth transfer of accountability and a successful C2P2 and transition from phase 1 to phase 2.
- Provide key support to the MCT post-approval in first major markets ensuring that the MDT provide optimal support to both registration and LCM.
- Selects members of the Medicines Development Team (MDT), in consultation with the line leaders, and leads this multi-disciplinary matrix team; supports differentiated development for team members; owns the performance of MDT and partners with line managers to drive performance
- Energizes and motivates the MDT to drive performance
- Establishes a compelling vision for the medicine; positions the medicine within the R&D strategy taking the competitive landscape into account; Translate GSK's strategy into asset strategy and actionable plans for multiple areas or functions.
- Delivers differentiated medicines of value for patients, stakeholders and markets, through an evidence package that supports regulatory approval, market access, and product life cycle.
- Delivers the Medicine Development Strategy that is aligned with the R&D disease strategy, as well as the asset Medicine Vision and Medicine Profile.
- Prioritizes and maximizes the assets portfolio options including developing multiple indications. Makes clear evidence-based go / no go / accelerate decisions, based on whether the results fulfil the strategy set out for the medicine, and identify clear inflection points
- Embeds core processes including cost efficiency, adoption of new technology, risk identification & management, compliance with policy
- Identifies and aligns resources (people and financial), team objectives and strategies behind the vision to ensure successful project completion
- Proactively identifies unmet medical needs that could be addressed through line extensions
- Enhances patient focus by incorporating the voice of the patient into development plans.
- Promotes organizational reputation and drives asset value by engaging and negotiating with internal and external stakeholders
- Collaborates with other stakeholders but in particular EDLs and other MDLs to create strategies that support organizational vision; shares optimal ways of working and knowledge
- Ensures quality & compliance oversight in line with R&D expectations and project needs; assures quality of data and science
- Prioritizes and manages asset portfolio options to meet budget constraints.
- Ensures excellence in execution of all governance processes, including oversight of all studies, pharmacovigilance, scientific engagement and promotional practices.
Professional experience/ qualifications
- Advanced degree such as PhD, PhRMD, MBA or equivalent is highly preferable
- Must demonstrate extensive broad drug development expertise and experience including filing experience
- Prior significant experience in leading successful development and registration of medicines is highly preferred
- Deep experience in product development and/or commercial, especially in late phase development (from PoC onwards), clinical trial management with significant operational complexity, post-approval studies, regulatory and manufacturing compliance
- Highly developed ethics and integrity, with demonstrated ethical medical decision-making skills.
- Understands the entirety of R&D across the development/commercial life cycle to allow impact across all functions: discovery, late stage development, regulatory, manufacturing and commercial.
- Track record of success working in highly complex, matrixed, global, and multi-disciplinary organization with high accountability, minimal authority, and multiple lines of reporting
- Experience working with regulators and regulatory requirements including an understanding of the legal and government frameworks within and across global geographies.
- Strong people management, leadership and motivational skills
- In-depth experience creating the strategy for pre- and post-marketing studies, and driving the lifecycle process
- Ability to work collaboratively and successfully across functions - research, commercial, regulatory, global medicine supply, legal, regions etc.
- Ability to build relationships and create authentic alignment while leading high performing teams in a collaborative and purposeful manner to achieve defined objectives
- Must be able to clearly demonstrate a thorough understanding of the healthcare environment including all key external stakeholders
- Business acumen and experience of managing a sizable P&L which has organizational impact. Experience of building budgets and then leading the strategic and budget planning process
- Track record of leading with high operational complexity. Including global, geographically dispersed teams, multi-disciplinary structures with high accountability, minimal authority, and multiple lines of reporting
Pivotal Experience & Expertise
- Asset Development Leadership Experience : Having previously operated in a similar role or environment to the GSK Medicine Development Leader, with end-to-end asset leadership including overseeing clinical development, medical affairs, safety, regulatory, commercial, product development and manufacturing, will be a distinct advantage.
- Therapeutic Area Experience: Previous direct experience in the therapeutic field of Immunology / Inflammation will be a differentiator.
- Drug Development Expertise: Extensive and broad drug development experience and prior experience in leading successful development and registration of medicines is highly preferred
- Product Development: experience in product development and/or commercial, especially in late phase development (from PoC onwards), clinical trial management with significant operational complexity, post-approval studies, regulatory and manufacturing compliance
- Project Management: experience of managing different business functions and creates alignment between different project indications and asset teams with different objectives.
Leadership & Performance Characteristics
- A talented and experienced leader motivated by the desire to make a difference in patients' lives.
- Excited by challenging goals and positively impacting the progression of medicines of value to patients that provide the adequate return to the business.
- Proven ability to think and plan uniquely and strategically, to work with members of other functions within a matrix environment.
- Intrigued by innovation, creativity and new opportunities to learn
- Energized by delivering high standards through collaboration and motivating others across the organization
- Passionate about developing others into future leaders
- Committed to maintaining the highest compliance standards
Closing date for applications: 11 June 2021
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