Value Evidence Director - VEO, Specialty - Lupus focus
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 (ie 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 current evidence requirements for reimbursement and access, recognizing the challenges these pose for drug developers and identifying tactics to address these challenges.
Value Evidence and Outcomes:
The VEO vision is that GSK commercialises medicines of value to internal and external stakeholders. We drive the definition and demonstration of value for GSK medicines, optimising patient benefit and access. We have a particular focus on Real World Evidence (RWE) and believe that GSK will lead the industry in the generation of impactful RWE.
Role supporting Specialty assets:
The VEO Director will be responsible for the process of planning, generating and delivering health outcomes and economic evidence across the different stages of drug development to demonstrate the value of our medicines to payers, regulators, healthcare providers, and patients. The global Value Evidence Director will sit in the VEO group, reporting to the Value Evidence Leader, and support specific assets in the Specialty area within development or research.
The Specialty area is an exciting place with pipeline assets across many disease areas and also includes Benlysta a key launched asset for Lupus. With a recent successful study in Lupus Nephritis, a combination study reading out in the coming year, as well as a reimbursement submission currently ongoing in China, there is a need for a Value Evidence Director to drive forward further plan for Benlysta. Focussing on a disease of unmet need, this role allows the successful candidate to support value of an innovative therapy as it reaches a key stage of its life cycle
VEO directors are critical to assessing the value evidence requirements of our launched and pipeline assets through stakeholder insights and implementing tactics to address these. The successful candidate will work closely with asset teams to address strategic questions. For example, what is the level of unmet need, how do our assets address this versus competitors, what is the key evidence required to address market access challenges at launch and beyond?
VEO input into the Integrated Evidence Plan (IEP) in select pipeline assets/indications
VEO Projects supporting the IEP, bringing required technical knowledge and ensuring high quality of deliverables
Specific sub-teams, projects, or external collaborations as identified through interactions with VET (Value Evidence Team) including health outcomes, epidemiology, statistics, clinical, medical affairs and potentially lead the VET.
Transparency of evidence generation activities within the Franchise markets to the IET.
At direction of Head, TA lead or Sr. Director, VEL, support external collaborations and scientific evidence requirements with reimbursement bodies and decision makers (eg formal scientific advice).
The role(s) will involve working closely with many stakeholders including Early/Medicine Development Leaders, Global Commercial Leads, Physician Leads, RWE and Epidemiology, Patient Focussed Outcomes, Patients in Partnership team, Market Access, Clinical Scientists etc. Areas for partnership will include
o Clinical trial design in alignment with stakeholder insights and the IEP.
o Working with LOC colleagues to ensure local evidence generation needs are met in line with the medicine strategy
o Working with commercial, market access and patients in partnership and other colleagues to gain insights into evidence generation requirements
o Working with teams to drive the medicine strategy and prepare for internal governance reviews
Key evidence supporting internal governance reviews and reimbursement submissions
The Value Evidence and Outcomes specific activities as defined in the IEP (Patient Reported Outcomes strategy, economic modelling, real world evidence, indirect comparisons, etc) ensuring the scientific robustness of the study protocol, study execution, analyses, and reporting.
The Value Evidence and Outcomes materials to inform internal governance decision making or support Franchise LOCs' reimbursement activities depending on stage of development.
Value Evidence and Outcomes input to regulatory documents with accuracy and scientific integrity.
Compliance with necessary regulations for quality and disclosure.
Basic Qualifications and Experience:
Masters degree or higher in Health outcomes, patient reported outcomes, health economics, epidemiology, pharmacy, health or life sciences.
Significant experience in health outcomes or an aligned discipline/function
Pharmaceutical experience that includes: Drug development and/or and launch experience in support of value evidence generation
Leadership, networking, communication and influencing skills to work effectively in a complex Matrix environment.
Self-motivated ownership and accountability for projects, move them forward, and deliver with minimal supervision
Strong technical knowledge in key areas including economic modelling and observational studies
Exceptional written and verbal communication skills.
Strong critical thinking strategically and tactically
Role requires the incumbent to have the credibility to bring a depth and breadth of experience to address external environmental challenges and develop value evidence generation strategies that will meet decision makers needs
Preferred Qualifications and Experience
Doctorate level (eg PhD, Pharm D) or higher level degree with commensurate industry and business qualification
Experience in Respiratory desirable by not mandatory
Global R&D and/or LOC experience
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