Role Summary
The Principal Scientist/Director, Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes Global Medical and Scientific Affairs as well as Outcomes Research.
Under the guidance of a senior leader, this position supports value evidence outcomes research plans and real-world evidence activities for in-line and pipeline products in prostate and kidney cancers to meet the value evidence needs of clinicians, payers, policymakers, health technology assessment (HTA)/reimbursement agencies and health systems globally.
Types of studies executed include prospective and retrospective observational studies to characterize disease burden and epidemiology, treatment patterns, health-care resource utilization and costs, physician and patient satisfaction surveys, clinical and patient-reported outcomes assessments, systematic reviews and meta-analyses, and economic modelling. Key responsibilities also include development of American Managed Care Pharmacy (AMCP) dossiers for U.S. payers and Global Value Dossiers for use by local subsidiaries in their HTA submissions.
The incumbent is expected to contribute to product development and marketing strategies throughout the lifecycle to ensure that product value is defined and developed to achieve optimal market/patient access and reimbursement. The incumbent is expected to work cross-functionally with clinical development, medical affairs, biostatistics, market access, commercial, and country affiliates and may have direct interactions with HTA agencies, reimbursement decision makers, and national immunization technical advisory groups.
Responsibilities and Primary Activities
•Partners with Medical Affairs counterparts to develop, execute and deliver on the Value and Implementation (V&I) plan.
•Helps achieve / sustain reimbursement and market access for the program and indications under their responsibility.
•Critically assesses drivers and barriers to reimbursement and market access, and provides input into clinical, regulatory, payer/access, marketing and evidence generation strategies and programs.
•In collaboration with internal teams and external partners, designs studies; authors study protocols; and develops measurement questionnaires, case report forms, data analysis plans, final study reports, scientific presentations, and publications.
•Responsible for study-related contracting, budgets, and vendor/partner management and ensures study conduct is aligned with company Policies and standard operating procedures (SOPs) and world-wide regulations and standards, including Good Pharmacoepidemiology Practice (GPP) for applicable work.
•Develops American Managed Care Pharmacy (AMCP) dossiers for U.S. payers and Global Value Dossiers.
•Develops supplementary clinical data package in close partnership with markets and HTA statistics group for submission to HTA agencies.
•Supports country affiliates to understand local evidence generation needs, adapts health economic evaluations, and customizes outcomes research documents, such as protocols and reimbursement dossiers, according to local requirements.
•Works closely with cross-functional teams to effectively communicate outcomes research and health economic modelling data internally and to external stakeholders.
•Maintains awareness of new scientific and methodological developments within therapeutic area.
•Builds relationships with scientific experts worldwide.
•Presents outcomes research data at national and international congresses and publishes articles in scientific journals.
Required Qualifications, Skills and Experience
•Doctoral degree (PhD, MD, DrPH, ScD, or PharmD with fellowship in relevant discipline (Health services research, Outcomes research, Epidemiology, Public health, Health economics, Pharmacoeconomics, Pharmacy administration))
•Four or more years of experience post-doctoral degree or 7+ years of experience post master's degree in life science industry conducting NIR and generating Value Evidence
•Oncology experience
The following skills and knowledge are needed to be successful in this role:
•Decision making: Identifying and understanding problems and opportunities by gathering, analyzing and interpreting quantitative and qualitative information; choosing the best course of action by establishing clear decision criteria, generating and evaluating alternatives, and making timely decisions; taking action that is consistent with available facts and constraints and optimizes probable consequences.
•Emotional intelligence: Meeting the personal needs of individuals to build trust, encourage two-way communication and strengthen relationships. Ability to work with difficult stakeholders while achieving business results.
•Networking and partnerships: Building partnerships; developing and leveraging relationships within and across work groups to achieve results.
•Innovation: Creating novel solutions with measurable value for existing and potential customers (internal or external); experimenting with new ways to solve work problems and seize opportunities that result in unique and differentiated solutions.
•Knowledge of evolving payer and reimbursement environment: Educate the asset teams on impact of US Value Assessment and other key market HTA requirements on the asset and possible mitigation strategies.
Required Skills: Data Analysis, Data Management, Emotional Intelligence, Evidence Gathering, Health Economics, Market Assessments, Market Opportunity Analysis, Observational Studies, Outcomes Research, Pharmacoeconomics, Product Management Strategy, Qualitative Analysis, Researching, Research Reporting, Stakeholder Negotiations, Stakeholder Relationship Management, Strategic Planning, Study Design, Value Propositions, Values Assessment
Preferred Skills: Real World Evidence (RWE)
Additional Information
•Primary location: USA - Pennsylvania - North Wales (Upper Gwynedd)
•Salary range for the primary location: $190,800.00 - $300,300.00 (reflects the Company's reasonable expectation of base salary at time of posting; actual placement depends on education, qualifications, certifications, experience, skills, geographic location, government requirements, and business needs). Eligible for annual bonus and long-term incentive, if applicable.
•Comprehensive benefits package: medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days.
•Employee Status: Regular
•Relocation: Domestic
•VISA Sponsorship: Yes
•Travel Requirements: No Travel Required
•Flexible Work Arrangements: Hybrid
•Shift: 1st - Day
•Valid Driving License: No
