Director, Value and Evidence

Rhythm Pharmaceuticals•Boston, MA

3d•Hybrid

About The Position

Rhythm seeks an experienced individual to join our Medical Affairs North America team as Director, Value & Evidence. This position will serve as a strategic bridge between clinical development, regulatory and commercial roles, responsible for generating high quality evidence to maximize the value proposition of our assets across multiple indications associated with rare neuroendocrine diseases. This role requires leading the design and execution of studies with a focus on Patient Reported Outcomes (PRO)/Clinical Outcomes Assessments (COA), real world evidence generation and health economics and value dissemination. This individual will collaborate across regional teams, delivering evidence and/or tools to optimize decision making, support access and reimbursement and inform medical and clinical research protocols. This position will report to the Head of Value & Evidence (V&E).

Requirements

10+ years of relevant education and experience, including time in the bio-pharmaceuticals industry, with majority of experience in PRO drug development, regulatory submissions and the commercialization process, including designing health economics and outcomes research and evidence generation independently/autonomously.
Advanced degree in epidemiology, health economics, pharmaceutical sciences, or related discipline (MS, MPH, PharmD, PhD) preferred.
Experience in rare diseases strongly preferred.
Knowledge of the drug development & commercialization process, HTA assessment methodologies, global reimbursement, US payers and regulatory requirements.
Experience in developing submissions to European-based HTA organizations.
Excellent communication, collaboration and influencing skills across internal and external stakeholders.
Well-organized with strong project management skills and ability to prioritize workload

Responsibilities

Demonstrate proven methodological and analytical expertise regarding the collection, analysis, and utilization of real-world data to provide high-quality project deliverables including abstracts, posters, and manuscripts.
Demonstrate proven expertise leading Health Economic and Outcomes Research (HEOR)/real world research in the forms of COA development and/or its validation, database analysis, observational research, PRO endpoint inclusion in product labeling and other types of HEOR research.
Proactively propose and prepare outcomes research protocols, statistical analysis plans (SAPs), and reports.
Drive longitudinal retrospective studies of existing databases to assess patient characteristics, treatment patterns, and associated clinical, economic and/or patient-reported outcomes.
Lead retrospective or prospective evaluations of disease natural history and treatment patterns, including drug utilization and adherence.
Drive cross-sectional surveys of patients, caregivers, health care providers/practitioners, and/or payers/health technology assessment authorities.
Lead clinical-economic models and assessments exploring burden of illness and/or comparative effectiveness.
Ensure findings are communicated effectively, and as appropriate in conference presentations, publications, dossiers and other means.
Create robust health technology assessment (HTA) tools to meet the evidentiary standards of regulators, HTA organizations, reimbursement authorities, third-party payers and other organizations that review evidence for formulary and access decision making.
Ensure and drive strategic alignment with internal teams including Medical Affairs, Market Access, Regulatory, Commercial, International and Clinical Development to incorporate strategic HEOR and COA needs at every stage of development program and throughout commercial availability.