Job DescriptionHave you built experiences in/outside of oncology clinical development that have you poised to be accountable for all non-marketing global product activities at an asset level for medicines from Commit to Phase 2 to post-launch LCM? If so, this VP level career opportunity may be for you. GSK
Our Oncology R&D organization is building a diverse portfolio of Oncology medicines, focused on maximizing patient survival through transformation medicines. We aim to deliver first-to-market and first-in-class solutions that have the potential to address some of the biggest challenges in oncology.
Our organization covers the entire research and development spectrum from discovery to clinical development and regulatory compliance. We partner with other R&D functions, including Commercial and Medical to build our pipeline, manage trials, and progress from development to commercialization. We also pursue and manage critical business development opportunities, collaborations and acquisitions to advance our mission.
GSK continues to be committed to the discovery and development of new oncology therapies with the life-changing potential of helping patients with cancer, specifically in four areas of cancer research: •Immuno-Oncology -
Focused on an innovative pipeline of immune modulators designed to leverage a patient's immune system to recognize and eradicate solid and liquid tumors. • Cell/Gene Therapy -
Engineering next generation cell therapies for treatment of advanced malignancies. •Tumor Cell Targeting -
Target tumor-specific alterations to introduce selective anti-cancer activity.
•Synthetic Lethality -
Optimizing the use of PARP-inhibitors and delivering a Repertoire of Synthetic Lethal Medicines.
For more information on these areas of focus, read GSK's: JOB DESCRIPTION:
The core purpose of the MDL is to strategically lead the optimal global development of a medicine, acting as the single point of accountability for the medicine from C2P2 to approval in first major market, but substantially contributing and influencing from pre-C2P2 to post-launch life-cycle management, to ultimately deliver differentiated medicines of value.
By working with the various stakeholders across R&D and Pharma, the MDL defines the strategic vision and operational plan for the medicine, aligning it with the overall organizational strategy. The MDL creates and leads 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, amongst others). KEY RESPOSIBILITIES:
- 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.
- In addition to the overall leadership role, the MDL should provide key support to the Early Development Team (EDT) leading up to C2P2 to ensure smooth transfer of accountability and a successful C2P2 and transition from phase 1 to phase 2.
- In addition to the overall leadership role, the MDL should provide key support to the Medicines Commercialisation Team post-approval in first major markets ensuring that the MDT provide optimal support to both registration and lifecycle management.
- Selects members of the 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
- 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 asset's 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.
- Model Values and Leadership Expectations internally and externally
- Asset single point of contact and spokesperson to senior management and senior boards (e.g., Chief Scientific Officer, Head of Development, Chief Medical Officer, President of Pharma, Development Review Board and Portfolio Investment Board) and other relevant internal governance committees and external Advisory Committees as needed.
- Increases visibility amongst the external communities (physicians, regulators, patients, payers), to bring medical solutions to patients with unmet medical needs, thereby enhancing reputation of GSK.
- MDL serves as the single accountable decision maker to resolve disputes among the MDT. The MDL should discuss any team misalignment/disputes with the Head of Development prior to rending a final decision.
- MDL is accountable for delivering and managing the asset resourcing plan. In addition, the MDL is accountable for managing the asset budget to the agreed variance.
- MDL is accountable for developing an ongoing patent strategy for the asset
- Partners with Business Development to facilitate diligence reviews, product positioning and/or alternative business strategies (e.g., public private partnerships, co-development) and internal review and decision-making processes in line with GSK governance procedures as well as use of appropriate alliance management mechanisms to ensure successful business transactions and relationships.
#LI-Onsite Candidate Profile Professional experience/qualifications
- Advanced degree such as MD, PhD, or PharmD, or equivalent is highly preferable
- Filing experience BLA/NDA/ MAA submissions as a core responsibility and have led development programs.
- Must demonstrate extensive broad drug development expertise and experience
- At least 7 years pharmaceutical industry experience
- Prior significant experience in leading successful development and registration of medicines
- Deep experience in product development and/or commercial, especially in late phase Oncology 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
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years.We're on track to separate and create two new companies in mid-2022:New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.
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