Senior Director, Patient Reported Outcomes

Revolution Medicines•Redwood City, CA

13d•$236,000 - $295,000•Onsite

About The Position

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: The Senior Director, Patient Reported Outcomes is responsible for leading the strategy and execution of Patient Reported Outcomes (PROs) strategies, plans and activities related to all Revolution medicines assets. This role shapes the vision for integrating PROs into clinical development, regulatory submissions, medical affairs, and global market access strategies. Operating across functions and geographies, this leader influences senior internal stakeholders and external bodies to drive scalable patient-centered solutions that accelerate access and demonstrate treatment value.. Reporting to the Executive Director, Payer & HTA Strategy, the Senior Director of PROs will sit on their leadership team and provide input into the broader remit of the group. This is an exceptional opportunity to contribute to the advancement of healthcare by providing evidence that can shape the future of patient care in Oncology.

Requirements

Candidates are required to have a Ph.D. or equivalent degree in a relevant discipline (e.g., psychology, psychometrics, outcomes research, public health) or those who possess a clinical doctorate (M.D., Pharm.D.) coupled with a master’s degree.
The candidate should possess a minimum of 13 years of related experience, including a minimum of 6 years of leadership in the pharmaceutical industry, regulatory or CRO space.
Strong ability to work effectively across broad matrix teams and the ability to influence and align with Senior Leadership.
Experience with the application of PRO measures in hematology and oncology areas.
Experience conducting observational research involving PRO data collection and the interpretation and communication of results to key stakeholders.
Experienced with PRO requirements for regulatory and HTA/reimbursement agencies, including deep working understanding of the FDA Patient-Reported Outcomes Guidance.
Knowledge of development and validation of COA measures.
Understanding of health care markets and regulatory and reimbursement decision making, especially in relation to the global use of PRO data.
Be abreast of rapidly changing methodological and regulatory environment.
Strong analytical and synthesis skills.
Demonstrated ability to understand and communicate with matrix teams.

Nice To Haves

Knowledge of the drug development process within hematology/oncology preferred.

Responsibilities

Defines strategic execution roadmap and develop metrics to assess impact of PROs on business value and patient outcomes
Will work across internal stakeholders, Rev Med leadership and external groups to drive patient centered solutions.
Maximizes the impact of evidence of treatment benefit by providing input to briefing packages, publication strategies, and market access strategy.
Be a ambassador and promotes the importance of PROs’ role to quantitative and qualitative COA across senior leadership.
Leads PRO/COA governance structure and align cross-functional stakeholders across development, medical, commercial, and access functions.
Leads the preparation of relevant sections of documents and communications for regulatory agency meetings, support and/or participate in said meetings at regulatory agencies, and provide robust evidence in support of submission activities.
Oversees the dissemination of results from clinical trials as well as PRO development and validation studies that are aligned with publication strategy.
Participates in global external collaborations regarding policies, standards, and use of measures (e.g., PRO Consortium, BIO PFDD Task Force, EuroQol Group, ISPOR working groups).
Participates in creating and delivering education on measures for internal business partners.
Guides operations staff in securing licenses and commissioning translations/adaptations for instruments in a timely manner.