Director, Global Health Outcomes, ViiV Healthcare, Open to flexible working
ViiV healthcare is a pharmaceutical company focused exclusively on HIV, with the community central to everything that we do.
As a company focused exclusively on HIV, ViiV Healthcare is embarking on a paradigm changing strategy to treat people living with HIV (PLWHIV). A progressive scientific platform has enabled ViiV Healthcare to build a pipeline of innovative therapies including 2 drug regimens, long acting (LA) injectables for both treatment and prevention, a drug in a completely new class for heavily treatment experienced patients, and a paediatric formulation, fulfilling the ViiV wider mission, to leave no person living with, or at risk of HIV left behind. Our innovative development pipeline includes molecules with new modes of action and methods of delivery, targeting 2DRs parenterally delivered.
As part of the Research & Development and Global Medical Group (RDGM), the Global Health Outcomes (GHO) team is key in furthering the RDGM vision: Dedicated to delivering innovative HIV medicines, leaving no patients behind. GHO drives the demonstration of value for ViiV's current and growing HIV portfolio, optimising patient benefit and access, with a growing focus on Patient Centred Outcomes (PCOs) and Real-World Evidence (RWE).
Healthcare decision makers depend on manufacturers to generate evidence for new products to launch and maintain access. Lack of appropriate evidence to quantify the efficacy and safety of novel compounds and limitations in accessibility and usability of evidence (i.e. applicability of evidence supplied to the real-world) have been identified as barriers for informed healthcare decision making. Achieving and maintaining market access for a new product involves understanding the value evidence requirements for reimbursement and access, recognizing the challenges these pose for drug developers and identifying tactics to address these challenges.
- Support the global strategy and delivery of value evidence for HIV assets/medicines.
- Assess the value evidence requirements of our pipeline assets through stakeholder insights and prioritizing evidence gaps and develop and implement plans to address these.
- Manage, and implement key aspects of evidence generation strategies to support ViiV pipeline assets and inform the target product profile (TPP), including early health economic modelling, PCOs, burden/cost of illness and RWE studies.
- Collaborate closely with other members of the Global and Regional Health Outcomes teams, working in partnership with matrix disciplines such as the early development team to ensure integration of strategy and health outcomes studies/data to support internal decision-making during product development, commercialization and life cycle management.
- Ensure that the patient's voice is included in product development: Responsible for development of PCO/clinical outcome assessment (COA) endpoint strategies, and the development and validation of PROs to support registration, reimbursement and differentiation of GSK assets in development.
- Project and vendor management. Track and adjust global HO projects across team and with external contractors and suppliers to ensure delivery on time, to budget and in accordance with user specifications
- Collaborate with senior stakeholders in ensuring quality of deliverables, including review and sign-off of project specifications, protocols, data analysis plans, final study reports, publications.
- GHO input to the Integrated Evidence Plan (IEP) through key interactions with the Integrated Evidence Team (IET).
- GHO projects supporting the IEP, bringing required technical knowledge and ensuring high quality of deliverables.
- Specific sub-teams, projects, or external collaborations involved in evidence generation, including functions such as health outcomes, epidemiology, statistics, clinical, medical affairs.
- External collaborations and scientific evidence requirements with reimbursement bodies, academic groups and decision makers (e.g. formal scientific advice).
- Working closely with many stakeholders including Global and Regional Medical and Commercial Leads and team members, Market Access, Early Development teams, Physician Leads, Epidemiology/RWE, Patient Centred Outcomes, Clinical Scientists etc. Areas for partnership will include:
- Study design in alignment with stakeholder insights and the IEP, including PCO and endpoint development.
- Working with LOC colleagues to ensure local evidence generation needs are met in line with the medicine strategy.
- Working with commercial, market access, patient-aligned roles and other colleagues to gain insights into evidence generation requirements.
- Engagement with external organizations, including academic units, professional groups, regulatory- and reimbursement authorities, to support ViiV's presence in the relevant fields.
- HEOR specific activities as defined in the IEP (economic modelling, RWE projects, indirect comparisons, PRO studies, etc) ensuring the scientific robustness of the study protocol, study execution, analyses, and reporting. This will frequently be in collaboration with CROs.
- Ensure payer insights are captured globally and ensure they are effectively prioritised in the Integrated Evidence Plan.
- GHO input to regulatory documents with accuracy and scientific integrity.
- Support reimbursement strategies across the ViiV portfolio, providing input to training sessions with local country teams.
- Impactful publications and downstream activities, including supporting the medical and commercial teams with communication materials and training to ensure optimal dissemination of the evidence.
- Compliance with necessary regulations for quality and disclosure.
- Accountable for tracking and managing budgets within the scope of the role.
- Master's degree or higher in health outcomes, health economics, epidemiology, pharmacy, health or life sciences.
- Significant experience in health outcomes or an aligned discipline/function.
- Pharmaceutical experience that includes value evidence generation to support drug development.
- Leadership, networking, communication and influencing skills to work effectively in a complex matrix environment.
- Self-motivated ownership and accountability for projects, to move them forward, and deliver with minimal supervision.
- Strong technical knowledge in key areas including patient centered outcomes, economic modelling and observational studies.
- Exceptional written and verbal communication skills.
- Strong critical thinking strategically and tactically
- Role requires credibility and personal authority, to bring a depth and breadth of experience to address external environmental challenges and influence the development teams to pursue evidence generation strategies that will meet decision makers' needs.
- Excellent communication and project management skills to successfully operate as GHO functional lead in cross-functional teams to identify needs and develop health outcomes strategies.
Preferred Qualifications and Experience
- Doctorate level (e.g. PhD, Pharm D) or higher-level degree with commensurate industry and business qualification.
- Experience in HIV/Infectious Diseases desirable but not mandatory.
- Global R&D and local operating company experience.
The close date for this position will be Tuesday 24th November 2020 COB.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at ViiV Healthcare bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
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