Director, Patient Reported Outcomes and Pipeline

Overview

The Director of Patient Reported Outcomes (PRO) and Pipeline will work with cross-functional partners including clinical development, biostatistics, market access, medical affairs, commercial, regulatory and others to align on the value hypotheses and value evidence needed in our clinical trials to optimally support Celldex products and their place in therapy. S/he will serve as a subject matter expert in PROs, and more broadly, clinical outcome assessments (COA) from analytic/psychometric and regulatory and health technology assessment (HTA) perspectives.

S/he will create early global value frameworks for products in the Celldex pipeline to build the foundation for the unmet needs and product value. S/he will engage with regulatory and HTA bodies as needed on the patient-centric endpoints included in the Celldex clinical development plan and optimize their inclusion in healthcare decision making.

• Build and lead patient-reported outcomes strategy and implementation for follow on indications for Celldex late-stage compounds in development as well as priority early pipeline candidates.
• Establish and standardize internal processes and framework for the evaluation and selection of PRO endpoints, operational aspects, endpoint hierarchy in clinical trials, regulatory engagement, analytic and publication strategy.
• Educate cross-functional partners on best practices, regulatory guidance and evaluation framework, and analytic/psychometric approaches.
• Conduct literature reviews, qualitative (and if needed quantitative) patient research to support PRO endpoint strategy.
• Collaborate with clinical development and clinical operations on the strategy on quality and comprehensiveness in PRO data collection and operational execution.
• Co-create regulatory engagement strategy with clinical development, regulatory affairs and biostatistics colleagues as appropriate and compile relevant information for briefing books, regulatory interactions and requests for information.
• Serve as HEOR lead on early asset teams and work with commercial pipeline leader and the program development strategy team and other internal stakeholders on target product profile development and refinement.
• Conduct horizon scanning and targeted literature searches to understand the treatment landscape and regulatory and HTA value assessments for other products used and approved in the health conditions of interest.

• Master s degree (MPH, MSc) or higher (PhD, Pharm
  
  D, SciD, MD) in relevant discipline (epidemiology, psychology, medicine, health economics, pharmacy, math, engineering, biostatistics, etc)
• Relevant coursework in biostatistics, observational research, psychometrics, health economics
• Data analysis skills and working knowledge of biostatistics required
• Psychometrics and qualitative research experience
• Strategic skills in mapping the value hypotheses for Celldex compounds vis-à-vis comparators for PRO and HEOR, market access perspectives
• Significant contributions to regulatory engagements for PROs, including authoring briefing books, presenting at meetings, and responding to requests for information.
• Collaboration and communication will be required both across internal and external colleagues both at the technical level as well as at a conceptual strategic level
• Minimum 7+ years biopharma experience in HEOR, PROs, epidemiology, clinical research, analytic or strategic healthcare consulting in HEOR/market access.

The expected base salary range for this position is $176,659 to $229,427.

We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.

Compensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page.

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