Sr. Director, Integrated Evidence Generation Lead

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.

About the role

We are seeking an experienced leader responsible for providing scientific leadership for all evidence generation led by Medical Affairs, including Real-World Evidence, Expanded Access Programs, external research, and non-interventional trials. This role contributes to a unified, cross-functional integrated evidence generation plan (IEGP) that supports healthcare professionals, regulators, and payers throughout a product’s lifecycle. The position will shape the product’s medical strategy and provide expertise in the design, execution, and delivery of evidence generation, coordinating internal and external data sources to support clinical development, regulatory submissions, reimbursement, and lifecycle planning for oncology assets (solid tumor focus; NSCLC experience preferred).

Responsibilities

• 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.
• 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, and Alliance/Business Development.
• 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, and ensure methodological rigor and appropriate use of real-world endpoints (e.g., real-world PFS/OS, time to treatment discontinuation).
• Oversee 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.
• Lead and manage Investigator-Sponsored Research (ISR) programs, including governance processes, policies and procedures, review committee coordination, proposal evaluation, budget and contract oversight, compliance monitoring, and cross-functional stakeholder engagement.
• Manage end-to-end delivery of projects: vendor selection/oversight (data vendors, CROs, analytics partners), timelines, budgets, and quality/compliance (GCP/ICH, data privacy).
• 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 contextualize trial results.
• Represent the company externally in scientific forums, collaborations, and consortia; foster partnerships with academia, data providers, and research networks.

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.
• Director level: minimum 8–12 years of relevant experience in evidence generation, epidemiology, outcomes research, or HEOR with at least 5 years in oncology. 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 (pre- and post-approval).
• 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.

Skills

• Problem-Solver: Action-oriented self-starter eager to apply expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
• Personable: Establishes and nurtures highly effective relationships with colleagues and key stakeholders to support and advance project goals.
• Credible: Thorough understanding of clinical methodologies and sound analytical support; quickly establishes credibility as a reliable resource.
• Emotional Intelligence, Curiosity, and Innovation: Knack for building something better through adaptability and creative problem-solving.
• Communication: Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. Strong presenter and effective communicator with the ability to influence stakeholders.
• Accountability: Acts with a clear sense of ownership, holding yourself and others accountable to execute all tasks with high quality and integrity.
• Adaptability: Manages ambiguity well, embraces change, and reassesses priorities to align with evolving organizational goals.

Benefits

• Competitive base salary, bonus, and equity plans.
• Unlimited vacation and 10 sick days annually.
• Excellent medical, dental, and vision coverage.
• 401K with company matching.

Pay

The base pay offered will take into account internal equity and may vary depending on the candidate’s job-related knowledge, skills, experience, and location. Full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) as part of the compensation package.