Sr. Director, Integrated Evidence Generation Lead

Who we are...

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 responsible for providing scientific leadership for all evidence generation led by Medical Affairs, including but not limited to Real-World Evidence, Expanded Access Programs, external research, and non-interventional trials that contribute to a unified, cross-functional integrated evidence generation plan (IEGP) that supports HCPs, regulators, and payers throughout a product’s lifecycle.

This role will contribute to the product’s medical strategy and provide expertise in the design, execution and delivery of evidence generation, including the coordination and optimization of other data sources (internal and external) 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, Commercial, Market Access/Health Economics, Regulatory and external stakeholders to generate high‑quality data to inform 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 evidence generation activities. Successful partnership with Medical Affairs Asset Strategy Leads is required to ensure efforts are strategically aligned to product strategies and business needs.

Evidence Generation Strategy

• Partner with Medical Strategy Asset Leads to develop and maintain integrated Evidence Generation Plans (IEGPs) across the oncology portfolio, ensuring alignment with lifecycle management objectives.
  • Identify and prioritize evidence gaps across clinical, economic, and real-world settings to inform evidence generation investments.
  • Partner with Clinical Development, Commercial, and Market Access to align evidence strategies with product differentiation and value demonstration goals.
  • Translate strategic business and scientific objectives into actionable evidence-generation initiatives.

Matrix Leadership & Cross-Functional Collaboration

• Serve as a matrix leader across internal functions including:
  • Medical Affairs
  • Clinical Development / Clinical Operations
  • Biostatistics / Data Science
  • Market Access / Health Economics
  • Commercial / Marketing
  • Legal / Compliance
  • Alliance / Business Development
• In partnership with Medical Strategy Leads, facilitate governance, prioritization, and decision-making forums for evidence generation programs that address identified data gaps.
• Drive alignment across internal stakeholders and external partners on study priorities, timelines, and deliverables.
• Design, prioritize and oversee observational studies to address strategic data gaps, including 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.).
• Demonstrated experience overseeing Early Access Programs (EAPs), including cross-functional coordination, regulatory and compliance oversight, investigator/site engagement, operational execution, and management of compassionate use or expanded access activities for investigational therapies.
• Proven ability to lead and manage Investigator‑Sponsored Research (ISR) programs, including ownership of governance processes, policies and procedures, review committee coordination, proposal evaluation, budget and contract oversight, compliance monitoring, and cross-functional stakeholder…