Sr. Director, Patient Centered Outcomes Assessments (PCOA), Oncology & Therapeutics

The Role:

Moderna is seeking a Senior Director of Patient-Centered Outcomes Assessment (Sr. Dir, PCOA) to lead the design and development, strategy and measurement, and patient-centric evidence generation activities of Moderna’s mRNA technologies across Therapeutics & Oncology.  The Sr. Dir, PCOA has responsibility for the design, development, study conduct and analysis, reporting-- internally and externally-- (with health agencies), and publication of patient-centric Clinical Outcome Assessments (COA) studies.  In addition, the Sr. Dir, PCOA will provide consultation, guidance and input towards COA measurement strategies across all mRNA technologies in clinical trials or managed by clinical development.  Lastly, guide, consult and/or participate in patient-centric evidence generation activities (cross-sectional surveys, conjoint analyses, registries, etc) across the portfolio, where needed.

Specifically, Sr. Dir, PCOA will lead, guide and/or consult such activities for mRNA technologies focusing on Oncology (Onc), Rare Diseases (RD), Emerging (EM; such as cardiology, pulmonology) and Autoimmune (AI; such as graft vs. host disease).  The role will report to the Executive Director, Epidemiology, Oncology and Therapeutics.

The successful candidate is driven, curious, collaborative, with a bold ambition to contribute to ground-breaking drug development with potential to transform multiple diseases with high unmet medical need.  The candidate must have excellent oral and written communication skills, innovative approaches, and a collaborative mindset. The candidate will be charged with understanding the clinical development needs and opportunities to enhance drug development with the mRNA platform, and to build expertise where needed. The candidate must be able to guide teams on needs, but also lead PCOA development at a senior level on certain mRNA programs that require it, as capacity permits.

Here’s What You’ll Do:

• Accountable for establishing the vision, mission, standard operating procedures (SOPs) of the PCOA function with the Executive Director of Epidemiology

• Accountable for the leadership, design and development (or adaptation) of COAs including the conduct of qualitative and quantitative concept elicitation and cognitive debriefing and validation studies; including guiding qualitative and psychometric analysis plans, study reporting-- internally and externally-- with health agencies (briefing packages) and publications

• Responsible to review and support clinical development plans (CDPs) where COAs may be required for approval, regulatory label language/claims, but also to meet HTA body needs and/or to utilize innovative methodological approaches

• Leads or assists in scientific advice and interactions with regulatory agencies and HTA bodies for COA endpoints by preparing appropriate briefing documents and dossier.

• Consult and provide guidance and input towards COA measurement strategies across mRNA technologies in clinical trials or other studies (prospective observational studies, registries, etc) managed by clinical development across the product lifecycle

• Guide, consult and/or participate in patient-centric evidence generation studies such as non-interventional/observational validation studies, cross-sectional surveys, conjoint analyses, registries, etc) across the portfolio, where needed, especially when used to contextualize patient or product benefits, risk-benefit trade-offs, or the like for regulatory agencies.

• Design and execute literature reviews, gap analyses and/or concept mapping, as needed.

• Actively contribute to the development of Target Product Profiles, particularly in terms of demonstrating potential COA approval endpoints or claims and shaping post-approval measurement plans.

  • Builds the scientific case for COA endpoints for approval or labelling claims as needed and produce and/or provide COA evidence dossiers for regulatory filing.

• Guide and partner with cross-functional colleagues in clinical operations, clinical development, data management, patient advocacy and site experience (PASE), statistics, regulatory (and others where needed), on electronic solutions to minimize patient, site, investigator and sponsor burden and optimize costs, quality and efficiency of COA collection and measurement (linguistic translation, cultural adaptation, versioning, electronic vs. paper, etc).

• Serve as a key PCOA representative and partner with Clinical, Regulatory, Statistics, HEOR, Medical and Commercial in various forums- clinical development, operations meetings, etc.

• Develop collaborations with key external Patient Advocacy Associations, Academic institutions, PCOA research partners, psychometricians and clinical experts.

Here’s What Yo