Senior Director, Real-World Evidence Generation Lead

Nuvation Bio•Remote - Any State US, NY

31d

About The Position

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer. Nuvation Bio are seeking an experienced leader to lead the strategy, design, execution and delivery of real‑world evidence (RWE) programs to support clinical development, regulatory submissions, reimbursement, and lifecycle planning for oncology assets (solid tumor focus; NSCLC experience preferred). This role partners across clinical development, regulatory, HEOR, commercial and external stakeholders to generate high‑quality RWE that informs development decisions, label expansion, payer access and value communication. The ideal candidate will be a hands-on leader capable of managing multiple, ongoing projects. This position will serve as the central cross-functional partner for RWE activities, ensuring efforts are strategically aligned with Medical Affairs priorities.

Requirements

Advanced degree (PhD, MD, PharmD, DrPH, ScD) in epidemiology, biostatistics, oncology, public health or related field strongly preferred. Master’s degree (MPH, MS) with additional experience may be acceptable.
Senior Director level: typically 12+ years with demonstrated leadership of enterprise‑level RWE programs.
Proven track record designing and delivering observational studies and RWE that supported regulatory interactions, label decisions, market access/reimbursement and/or clinical development.
Deep knowledge of oncology clinical endpoints and treatment paradigms (NSCLC background preferred).
Strong familiarity with major RWD sources (EHR, oncology EHRs, claims, molecular/genomic registries, clinical registries) and data linkage approaches.
Hands‑on experience with advanced epidemiologic and causal inference methods; comfort partnering with quantitative teams (biostatistics, data science).
Experience managing vendors, CROs and multi‑disciplinary internal teams; demonstrated project and budget management skills.
Excellent written and oral communication; proven publication and conference presentation record preferred.
Ability to interact credibly with regulatory agencies, payers, KOLs and external collaborators.
Willingness to travel as needed.
Problem-Solver - As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
Emotional intelligence , curiosity, and a knack to figure out a way to build something better
Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.
Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.
Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.

Responsibilities

Develop and own the RWE generation strategy and roadmap for one or more oncology assets across development phases (IND → post‑marketing), aligned to clinical, regulatory and commercial objectives.
Design, prioritize and oversee observational studies, retrospective cohorts, pragmatic trials, external control arms, registries and database analyses using claims, EHR, oncology‑specific datasets, molecular/genomics registries and patient‑reported data.
Lead protocol and analysis plan development, provide scientific/epidemiologic oversight, ensure methodological rigor and appropriate use of real‑world endpoints (e.g., real-world PFS/OS, time to treatment discontinuation, etc.).
Manage end‑to‑end delivery of RWE projects: vendor selection/oversight (data vendors, CROs, analytics partners), timelines, budgets and quality/compliance (GCP/ICH, data privacy).
As appropriate, interface with regulatory agencies, payers and HTA bodies to align evidence generation and support submission packages; prepare briefing documents and participate in regulatory and payer meetings.
Collaborate with clinical development teams to integrate RWE approaches into protocol design (e.g., hybrid trials, external control arms) and to contextualize trial results.
Translate RWE findings into actionable insights—author scientific publications, conference abstracts, HEOR/payer dossiers and internal decision memos.
Champion best practices in RWE methods, causal inference, advanced analytics (propensity scores, weighting, instrumental variables), and emerging approaches (synthetic control arms, federated analyses).
Represent the company externally in scientific forums, collaborations, and consortia; foster partnerships with academia, data providers, and research networks.