Principal Scientist (Director) - Outcomes Research, Oncology Assets

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 pipeline products 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 oncology 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

Minimum: Master's degree in relevant discipline (health services research, outcomes research, epidemiology, public health, health economics, pharmacoeconomics, pharmacy administration). 8 or more years of experience post degree. Experience in the designated Therapeutic Area.

Preferred: Doctoral degree (PhD, MD, DrPH, ScD, PharmD) in relevant discipline (health services research, outcomes research, epidemiology, public health, health economics, pharmacoeconomics, pharmacy administration). 6 or more years of experience post degree. Experience with a product launch or indication launch.