Director, Real World Value and Evidence – Milvexian
About The Position
This role will report to the Therapeutic Area Lead Milvexian and is a member of the Milvexian Medical Affairs Team. In this position, the Director, Real World Value & Evidence (RWV&E) will be responsible for leading lifecycle medical adoption and market access scientific strategies, evidence generation, and dissemination plans for Milvexian including multiple indications. The Director will ensure real world evidence generation strategy and market access scientific support requirements are understood and built-in to the US business plans with value propositions that reflect the needs of key payer stakeholders and lead scientific strategic planning for RWE activities to enable medical adoption and market access. RWE activities this role is held accountable for include but are not limited to: formulating key research questions addressing key stakeholder needs, identifying key analytical questions to shape market access strategy, designing and conducting studies, planning and conducting market access analytics, managing publications, developing communication materials for external stakeholders (e.g., Evidence & Access decks) and internal stakeholders demonstrating impact, and partnering with internal stakeholders such as V&E FIELD to ensure effective and compliant communication to payer customers. The role ensures projects are aligned to the Integrated Evidence Generation Plan (IEGP) and business needs and executed on time. The Director will collaborate with internal and external experts to prioritize and generate rigorous scientific data, and develop dissemination plans to support the product’s IEGP. They will ensure compliance with regulatory, legal and commercial regulations (for example Contract Pricing Committee, Copy Approval Committee) in conducting research and dissemination of scientific information. The Director will collaborate with cross-functional business partners on scientific strategies to support medical adoption and market access for our products. They will directly initiate and manage research studies and other related projects. The Director will serve as subject matter, and functional area expert in responding to U.S-focused Health Technology/Value Assessments of our products by external organizations. They will ensure quality of design, execution, and publication of real-world evidence studies, and quality of models & tools developed for business partners. The Director will develop annual business plan budget, present to appropriate levels of management for approval, and manage budgeted funds appropriately. They will ensure quality in internal / external communications including publications, training support of RWE studies, and models and/or tools developed to support the product. The Director will serve as a leader on assigned cross-functional franchise teams, with internal partners such as RWE colleagues, Marketing, Medical Affairs, Strategic Customer Group, Global Commercial Strategy Organization, Epidemiology, Government Affairs and Policy, other J&J Operating Companies as needed.
Requirements
- A minimum of a Master’s degree in Public Health, Health Services Research, Economics, Epidemiology, Pharmacy, Health Policy, or a related discipline is required.
- A minimum of 6 or more years of relevant research experience.
- Expertise in healthcare industry, clinical knowledge or practice across multiple therapeutic areas, medical reimbursement, technical expertise in economic evaluations or patient reported outcomes, including data analysis and statistics.
- Excellent in leadership skills, collaboration, influencing and communication (both written and presentation).
- Serve as a leader on the assigned cross-functional franchise teams pertaining to observational data or research, market access scientific strategy, payer insights/ data needs, etc.
- Experience in communicating technical data both internally and externally to non-technical audiences.
- Independent high-level planning and execution of research strategies.
- Solid experience in conducting Real World Evidence studies applying health economics, patient-reported outcomes, retrospective data analyses, epidemiology or health services research.
- Firm understanding of drug development process including health economic inputs needed to support the value proposition.
- Firm understanding of regulatory standards for approval and communication of data.
- Firm understanding of United States health care systems and customers; specifically understanding unique business models and perspectives.
- Firm understanding of the uses of evidence-based medicine and comparative effectiveness analyses for health policy decision-making.
- Up to 20% travel required mostly national with occasional international travel.
Nice To Haves
- A Doctorate or other advanced degree is preferred.
- Experience in developing and gaining management approval for value-based scientific strategies and tactics to meet both commercial and scientific objectives for a given product or therapeutic area.
- Experience with cardiovascular or anticoagulation disease area research
- Experience with population health or implementation science.
Responsibilities
- Ensure real world evidence generation strategy and market access scientific support requirements are understood and built-in to the US business plans with value propositions that reflect the needs of key payer stakeholders and lead scientific strategic planning for RWE activities to enable medical adoption and market access.
- Formulate key research questions addressing key stakeholder needs, identify key analytical questions to shape market access strategy, design and conduct studies, plan and conduct market access analytics, manage publications, develop communication materials for external stakeholders (e.g., Evidence & Access decks) and internal stakeholders demonstrating impact, and partner with internal stakeholders such as V&E FIELD to ensure effective and compliant communication to payer customers.
- Ensure projects are aligned to the Integrated Evidence Generation Plan (IEGP) and business needs and executed on time.
- Collaborate with internal and external experts to prioritize and generate rigorous scientific data, and develop dissemination plans to support the product’s IEGP.
- Ensure compliance with regulatory, legal and commercial regulations (for example Contract Pricing Committee, Copy Approval Committee) in conducting research and dissemination of scientific information.
- Collaborate with cross-functional business partners on scientific strategies to support medical adoption and market access for our products.
- Directly initiate and manage research studies and other related projects.
- Serve as subject matter, and functional area expert in responding to U.S-focused Health Technology/Value Assessments of our products by external organizations.
- Ensure quality of design, execution, and publication of real-world evidence studies, and quality of models & tools developed for business partners.
- Develop annual business plan budget, present to appropriate levels of management for approval, and manage budgeted funds appropriately.
- Ensure quality in internal / external communications including publications, training support of RWE studies, and models and/or tools developed to support the product.
- Serve as a leader on assigned cross-functional franchise teams, with internal partners such as RWE colleagues, Marketing, Medical Affairs, Strategic Customer Group, Global Commercial Strategy Organization, Epidemiology, Government Affairs and Policy, other J&J Operating Companies as needed.
Benefits
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Director
