Principal Scientist, (Director) – Outcomes Research Full-time

Principal Scientist/Director

Under the guidance of a senior leader, a Principal Scientist/Director has primary responsibility for developing value evidence strategies, and planning/managing real world and economic evidence activities for in-line and pipeline products to meet the value evidence needs of clinicians, payers, policymakers, 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, healthcare 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 US 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 health technology assessment (HTA) agencies, reimbursement decision makers and national immunization technical advisory groups.

Depending on role, leads or participates in value evidence teams and develop or contribute to value evidence strategies for in-line and pipeline products. Obtains senior management approval of evidence generation plans. Provides outcomes research leadership on cross-functional regional and global teams

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, 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 to ensure study conduct is aligned with company Policies and SOPs and world-wide regulations and standards, including Good Pharmacoepidemiology Practice (GPP) for applicable work.

Develops American Managed Care Pharmacy (AMCP) dossiers for US 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, 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

Minimum: Master's degree (MSc, MPH) in relevant discipline (health services research, outcomes research, epidemiology, public health, health economics, Pharmacoeconomics, pharmacy administration)

4 or more years post degree work experience

Preferred: Doctoral degree (PhD, DrPH, ScD, PharmD) in relevant discipline (health services research, outcomes research, epidemiology, public health, health economics, Pharmacoeconomics, pharmacy administration)

Required Skills: Accountability, Biostatistics, Clinical Development, Clinical Outcomes, Data Management, Health Economics, Health Technology Assessment (HTA), Marketing Strategies, Neuroanatomy, Outcomes Research, Pathophysiology, Pharmacotherapy, Pharmacovigilance, Product Development, Project Reviews, Researching, Scientific Research, Stakeholder Relationship Management, Strategic Planning