Associate Director – Global HEOR, Evidence Generation

This is a fully remote position, open to applicants in California.

📋 Description

• Provide assistance for regulatory and commercial evidence generation requirements as part of the Medical and Patient Affairs team.

• Aid in the HEOR and Evidence Generation Strategy for ETX101 and the Encoded pipeline.

• Contribute to the implementation of a comprehensive global value evidence package.

• Develop and execute solutions that enhance value and facilitate patient access discussions.

• Shape, align, and support the execution of global HEOR strategies aimed at product approval, clinical differentiation, and patient access.

• Keep abreast of global HTA requirements, significant ex-US HTA bodies, and the landscape of US payer and value assessments.

• Implement HEOR-related commercial strategies during asset launches.

• Collaborate with Clinical, Regulatory, Commercial, Medical Affairs, and Patient Advocacy teams.

• Maintain an up-to-date understanding of global regulatory guidelines, compliance policies, and MLR review processes.

• Spearhead global HEOR research initiatives, including literature reviews, natural history studies, disease burden assessments, observational research, COA/PRO, and health economic and epidemiological modeling.

• Conduct systematic landscape assessments and identify data gaps.

• Manage research planning, budgeting, execution, dissemination, relationships with external vendors, and scientific partnerships.

• Ensure scientific rigor is upheld across proposals, protocols, and statistical analysis plans.

• Create best practices, governance frameworks, and educational resources to enhance HEOR capabilities.

• Advocate for the HEOR and payer perspective throughout the organization.

⛳️ Requirements

• A Master’s degree (MS, MPH), MD, PharmD, or PhD in Health Economics and Outcomes Research (HEOR), Epidemiology, Biostatistics, Public Health, Psychology, or a related quantitative/scientific discipline.

• At least 5 years of pertinent experience in the pharmaceutical industry or specialized consulting.

• A proven history in study design and execution pertaining to observational research, Patient Experience Data (PED), Clinical Outcome Assessments (COA/PRO) development, psychometric validation, and health economic modeling.

• Demonstrated capability to lead HEOR research from initial conceptualization and protocol development through to peer-reviewed publication and defense before global health authorities.

• Direct experience in preparing and delivering HEOR components for global regulatory submissions and Health Technology Assessment (HTA) processes.

• Exceptional project management skills, with experience in managing multiple complex projects, budgets, and relationships with external vendors in dynamic global matrix environments.

• Strong working knowledge of pharmaceutical compliance frameworks, legal/regulatory review processes, and clinical trial designs.

• Outstanding interpersonal and communication skills, with the ability to influence, collaborate, and align various internal and external stakeholders.

• Capability to quickly synthesize complex data to address strategic business inquiries and establish cross-functional HEOR best practices.

• Willingness to travel both domestically and internationally as required.

• Preferred: PhD in HEOR or a related scientific field.

• Preferred: experience in rare genetic disorders, neurology, epilepsy, neurodevelopmental disorders, pain, gene therapies, or cell therapies.

• Preferred: experience in supporting late-stage development, pre-launch commercialization, and global launch execution.

🏝️ Benefits

• Comprehensive benefits package, including competitive employer premium contributions.

• Meaningful stock option grants.

• PTO, sick time, and holiday pay.

• Generous Parental Leave program.

• Pre-tax medical and dependent care programs.

• Short-term Disability (STD), Long-term Disability (LTD), Life insurance, and Accidental Death & Dismemberment (AD&D).

• Opportunities for professional development.

• Team-building events.

• Fully stocked micro-kitchen.

• Fitness center available at the South San Francisco location.