Clinical Outcomes Director jobs in New Haven, CT

Overview

The Director, Health Economics & Outcomes Research (HEOR) will proactively help design and actively implement the integrated  HEOR strategies and tactics to support the clinical development and commercialization of barzolvolimab. The incumbent is expected to have the knowledge and skills to  design and execute a range of studies, health economics models and other HEOR activities including but not limited to comparative effectiveness studies, observational studies using real world data, patient reported outcomes, and economic/cost-effectiveness modeling for in-line and development compounds as required. The initial focus for this role will be on ensuring appropriate selection, validation, implementation, and analysis  of patient reported outcomes instruments in clinical trials for multiple indications  This person will also be responsible for leading the development of the Global Value Dossier (GVD) and Global Value Story (GVS); and working with key counterparts to localize and implement the strategy across different geographies.

The HEOR will report to the Executive Director of Medical Affairs Excellent interpersonal and communication skills will be necessary to support effective partnership with other key internal stakeholders from Clinical Science, Clinical Operations, Regulatory Affairs, New Product Development, and Marketing Demonstrated ability to effectively collaborate with external stakeholders including vendors and disease area/HEOR experts will also be required, with an EU and US focus. An innovative mindset, high attention to detail, data-driven problem solving attitude and a multi-stakeholder cross functional approach will be key.

Responsibilities

• Ensure that patient reported outcome tools selected for clinical development programs are appropriate to the indication, scientifically valid, and acceptable to health authorities. Develop and validate new tools if needed
• Provide HEOR expertise to the cross-functional team and ensuring that HEOR perspectives are represented in the strategic plans for assigned compound(s).
• Develop global HEOR tactics in alignment with key internal stakeholders that address data gaps for the product
• Lead and execute projects with external stakeholders & HEOR experts to ensure that Celldex sponsored HEOR initiatives are medically relevant, scientifically valid & clinically relevant and support the needs of regulators, patients, health care providers, payers and policy makers
• Develop and maintain product Global Value Dossiers (GVD) & Global Value Stories (GVS) to support local Health Technology Assessment (HTA) needs
• Lead the maintenance of a global HEOR repository with a library of tools and instruments that support data generation and HTA needs

Qualifications

• BA/BS degree or equivalent in a scientific or health care field required.  Advanced degree (MS, MPH, PhD, or PharmD) preferred.
• 6 years related experience in outcomes research including patient reported outcomes, health economics, or epidemiology
• Previous experience working on an innovative therapy in immunologic/inflammatory therapeutic areas advantageous
• Experience in understanding interface between clinical practice and outcomes research
• Experience in leveraging outcomes data in the appropriate clinical context
• Solid understanding of various HTA reimbursement and market access requirements and working understanding of industry and regulatory guidelines as they relate to HEOR and Medical Affairs
• Employs conceptual thinking and informational gathering in order to anticipate, identify, analyze and solve complex problems
• In-depth HEOR subject matter expert knowledge along with a broad knowledge of related disciplines (market access, clinical development, market research)
• Demonstrated strategic thinking and strong leadership skills
• A collaborative style of working and a strong sense of ethics, compliance and integrity
• Persuasive and effective presentation style with strong written and verbal communication skills
• Demonstrated problem solving and decision-making skills
• High attention to detail including proven ability to manage multiple, competing priorities

Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.