Description
Summary
The Health Economics & Outcomes Research (HEOR) Associate Director supports asset-specific payer evidence strategies, including patient-relevant outcomes strategy, to generate differentiated evidence, strengthen the payer value proposition, and optimize access for BioMarin assets across a specific therapeutic area of interest. This role contributes to shaping patient-relevant outcomes requirements within the clinical programs, helping ensure alignment with Regulatory, HTA and access needs. In partnership with internal cross-functional and external stakeholders, the Associate Director supports the design and execution of patient-relevant outcomes research initiatives.
The Associate Director builds effective working relationships with cross-functional partners across Value & Access, Commercial, Medical Affairs, Clinical Development, Regulatory Affairs and Patient Advocacy, while supporting engagement with external stakeholders including HTA agencies, payers and patient organizations. This role requires solid expertise in patient-relevant outcomes research and a strong understanding of market access, value and HTA frameworks.
The position reports to the Senior Director, HEOR within the Global HEOR team which sits within the Pricing Access Value & Evidence (PAVE) organization.
Description
• Lead the development, execution and communication of payer evidence strategies aligned with brand and Value & Access priorities for early-stage pipeline assets
• Collaborate closely with Value & Access, Commercial, Medical Affairs, Clinical Development & Regulatory Affairs & Patient Advocacy organizations
• Contribute to organizational understanding of payer and HTA requirements related to patient-relevant outcomes and health utility measurement
• Support the strategic assessment of patient-relevant outcomes requirements for HTA and access to support differentiation and value demonstration
• Ensure payer evidence requirements are incorporated into clinical development plans to enable optimal patient access
• Lead the development of cross-functionally aligned, asset-specific patient-relevant outcomes strategies informed by disease conceptual models
• Support patient-relevant endpoint planning and assist with implementation within clinical trials
• Lead early Joint Clinical Assessment (JCA) strategy development, including assessment of access implications and trade-offs across markets
• Assess payer evidence gaps and inform future integrated evidence planning for early-stage pipeline assets
• Manage and partner with external partners in the execution of asset-level patient-relevant outcomes strategies, including PRO development and validation, health state valuation studies (time trade-off or standard gamble), and patient preference research, as appropriate
• Support scientific interactions with HTA agencies, particularly scientific advice (e.g., EU HTA JSC, NICE, CADTH), including preparation of briefing materials and evidence packages related to PRO endpoints, MCIDs, etc
• Support scientific interactions with regulatory agencies and patient advocacy organizations
• In partnership with the Integrated Evidence Teams (IET), lead the exploration, analysis and interpretation of patient-relevant outcomes data from clinical trials to generate insights, and strengthen value propositions for HTA, payer and other stakeholders
• Shape strategic scientific communication plans, and support presentation and publication of research in peer-reviewed journals
• Support the assessment of business development opportunities against payer and HTA requirements to identify risks, evidence gaps, and access considerations
Education & Experience
• 7+ years of Pharma Industry experience with 4+ years of experience in HEOR roles in pharmaceutical companies or consulting, and at least 2 years of direct experience with patient-relevant outcomes research
• Advanced degree in health economics, outcomes research, epidemiology, public health, health services research, pharmacy, or a related scientific discipline
• Strong understanding of market access, value and global HTA frameworks
• Experience supporting the development and execution of patient-relevant outcomes strategies to meet payer and HTA requirements
• Prior experience contributing to the evaluation, development, and validation of PRO measures to support regulatory, payer, and HTA decision making
• Experience supporting HTA submissions, value dossiers, and patient-relevant briefing books
• Ability to collaborate and build alignment across cross-functional stakeholders, including Value & Access, Commercial, Medical Affairs, Clinical Development & Regulatory Affairs
• Ability to manage multiple initiatives and effectively prioritize in a dynamic, fast-paced environment
• Developing expertise within the patient-reported outcomes field, with a growing professional network
• Experience supporting engagement with external stakeholders, including HTA agencies, payers, health economists, clinical experts, and patient advocacy organizations
• Rare disease experience preferred
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
