Assoc Dir Health Economics & Outcomes Research, Solid Tumors

About the role

Develop and implement global HEOR strategies and programs for our portfolio throughout the product's lifecycle, to inform and support clinical development and regulatory needs during early pipeline phase and ensuring optimal market access.

Collaborate with business partners to develop and support compelling product value propositions with aim to optimize future patient access.

Identify HEOR evidence requirements and gaps, and design, conduct, and deliver studies and tools to support relative value demonstration and product differentiation.

Leverage RWD analytic tools and collaborate with HEOR RWDnA and Epidemiology teams generating insights to inform development programs and key business questions.

Co-lead conduct of regulatory-grade real world evidence studies and provide education on emerging opportunities for employing RWE across the solid tumor portfolio.

Collaborate on conduct and communication of epidemiology and pharmacoepidemiology analyses and studies.

Provide relevant input into selection of patient population, comparators and endpoints within clinical trials to enable demonstration of robust incremental value over standard of care that can facilitate optimal future patient access.

Develop and implement Clinical Outcomes Assessment (COA) measurement strategies and plans in support of product labeling, patient access and product differentiation.

Develop and validate COA endpoints for integration in clinical studies.

Produce COA evidence dossiers for regulatory submissions.

Evaluate relevant payer and health technology assessment (HTA) decisions, collect feedback in advisory meetings and apply key learnings to pipeline products.

Maintain an up-to-date awareness of regulatory (e.g. FDA, EMA) and payer/HTA considerations that may impact planning for and implementation of HEOR programs.

Report, publish and disseminate HEOR data and study results in compliance with company, industry and regulatory requirements.

Responsibilities

• Develop and implement global HEOR strategies and programs for our portfolio throughout the product's lifecycle, to inform and support clinical development and regulatory needs during early pipeline phase and ensuring optimal market access.
• Collaborate with business partners to develop and support compelling product value propositions with aim to optimize future patient access.
• Identify HEOR evidence requirements and gaps, and design, conduct, and deliver studies and tools to support relative value demonstration and product differentiation.
• Leverage RWD analytic tools and collaborate with HEOR RWDnA and Epidemiology teams generating insights to inform development programs and key business questions.
• Co-lead conduct of regulatory-grade real world evidence studies and provide education on emerging opportunities for employing RWE across the solid tumor portfolio.
• Collaborate on conduct and communication of epidemiology and pharmacoepidemiology analyses and studies.
• Provide relevant input into selection of patient population, comparators and endpoints within clinical trials to enable demonstration of robust incremental value over standard of care that can facilitate optimal future patient access.
• Develop and implement Clinical Outcomes Assessment (COA) measurement strategies and plans in support of product labeling, patient access and product differentiation.
• Develop and validate COA endpoints for integration in clinical studies.
• Produce COA evidence dossiers for regulatory submissions.
• Evaluate relevant payer and health technology assessment (HTA) decisions, collect feedback in advisory meetings and apply key learnings to pipeline products.
• Maintain an up-to-date awareness of regulatory (e.g. FDA, EMA) and payer/HTA considerations that may impact planning for and implementation of HEOR programs.
• Report, publish and disseminate HEOR data and study results in compliance with company, industry and regulatory requirements.

Requirements

• An Advanced graduate degree (Ph.D., MS, or MD, PharmD., B.Pharm with Master’s degree) in HEOR-related field (e.g. pharmacoepidemiology, epidemiology, healthcare/data analytics, health economics, health services research, public health).
• 4+ years with PhD or 6+ years with MS in HEOR; at least 3 years of life science company or healthcare consulting experience is a plus.
• Strong technical expertise required in design and conduct of HEOR studies and models.
• Solid understanding of regulatory (e.g. FDA, EMA) and HTA considerations.
• Experience in design and implementation of patient experience data in clinical trials, including experience in instrument selection, analysis and reporting of data.
• Experience with Oncology is preferred.

Qualifications

• Advanced graduate degree (Ph.D., MS, or MD, PharmD., B.Pharm with Master’s degree) in HEOR-related field (e.g. pharmacoepidemiology, epidemiology, healthcare/data analytics, health economics, health services research, public health).
• 4+ years with PhD or 6+ years with MS in HEOR; at least 3 years of life science company or healthcare consulting experience is a plus.
• Strong technical expertise required in design and conduct of HEOR studies and models.
• Solid understanding of regulatory (e.g. FDA, EMA) and HTA considerations.
• Experience in design and implementation of patient experience data in clinical trials, including experience in instrument selection, analysis and reporting of data.
• Experience with Oncology is preferred.

Skills

• Strong technical expertise required in design and conduct of HEOR studies and models.
• Solid understanding of regulatory (e.g. FDA, EMA) and HTA considerations.
• Experience in design and implementation of patient experience data in clinical trials, including experience in instrument selection, analysis and reporting of data.
• Experience with Oncology is preferred.

Benefits

Not specified

Pay

$176,100.00 - $287,300.00 annually

Schedule

Onsite 4 days/week