The Senior Director of HEOR will design, develop, oversee and/or execute Global Health Economic and Outcomes Research (HEOR) and Market Access Strategic Plans in support of existing and new clinical applications in coordination with Global Commercial, Global Medical Affairs, Clinical Development, Regional Market Access and the US and International/Affiliates. This individual will be a subject matter expert (SME) in building and translating clinical validity and clinical utility into economic and societal value
These may include, but are not limited to:
- Develop, execute and modify the Global Market Access Plans to leverage and demonstrate value.
- Actively participate on Clinical Specialists, Medical and Governmental Affairs teams to fully understand and continually refine product outcomes and economic positioning; ensure the alignment of HEOR and overall payer strategies as well as ensure alignment of tactical plans with commercial and medical strategy; contribute to pre-approval clinical utility and post-marketing studies.
- Collaborate with the Clinical Development, Regulatory and the BUs to ensure appropriate and timely integration of all relevant HEOR and payer evidence into the clinical trials and regulatory submissions to maximize the US, EU and Emerging Markets labels and value evidence.
- Ensure that appropriate global quantitative research and health economic modeling are undertaken to develop an integrated global approach for maximizing Launch prices and early/sustained market access.
- Lead HEOR team as the company expands this capability
- Develop and execute a comprehensive and compelling HEOR publication plan as a part of the product publication strategy to appropriately disseminate to the value messages and evidence.
Required Skills & Experience
- M.D. with a minimum of 7 years’ relevant industry experience or PhD, PharmD, MS, MPH, or MBA with 10 years of relevant industry experience in pipeline and marketed products. Experience in diagnostics/ Medical Technology value demonstration is strongly preferred
- Demonstrated span of control across multiple therapeutic areas or multiple indications, oncology experience strongly preferred
- US and Global launch experience
- Experience in negotiating label claims with FDA and other regulators, as well as public and private payor experience
- Strong methodological, quantitative and analytical skills combined with a sound understanding of how to successfully apply health economic research principles to support the commercial enterprise; demonstrated ability to think strategically and make sound health economic and business decisions
- Strong project management skills with oversight experience in both internal and external projects are necessary. Demonstrated multitasking and time management skills and experience are absolutely essential in this area
- Demonstrated understanding and experience in diagnostics/ Health Technology product development and/or commercialization (may be concurrent with health economics research and strategy experience). Experience in HE/PRO (Health Economics/Patient Reported Outcomes), clinical trial protocol, CRF (Case Report Forms) development, and a good understanding of study designs that produce clinically and economically relevant value information in both a development and post-launch time period
- Demonstrated understanding of legal and regulatory issues impacting HEOR and PRO labeling and promotional claims
- Demonstrated understanding of the dynamics of the US and Ex-US health care systems and financing mechanisms. Experience in dealing with pricing, reimbursement and HTA (Health Technology Assessment) in US and major EU markets is a plus
- Strong and interpersonal skills with demonstrated ability in participating and leading cross-functional teams, excellent skills in leading without authority, and negotiating and managing through influence
- Executive level communication skills
- Demonstrated experience in medical/scientific writing, internal/external educational training of HE and HE tools, third party payor support and KOL development
- 20% travel domestically with the possibility of some international
Internal and External Relationships
This individual will interact internally with multiple functions including Global Medical Affairs, Clinical Development, Commercial and Market Access Teams. External relationships will include payors, KOLs, and physicians.
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