Job Description
What you'll be doing 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.
You will be responsible for...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 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).
- 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.
- Represent the company externally in scientific forums, collaborations, and consortia; foster partnerships with academia, data providers, and research networks.
What Knowledge & Experience you'll bring to us...- 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 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.
Behavioral skills to be successful...- 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.
What we have for you! - Competitive Base Salary, Bonus, and Equity Plans
- Unlimited Vacation and 10 Sick Days Annually
- Excellent Medical, Dental, and Vision Coverage
- 401K with Company Matching
- and much more!
The base pay offered will take into account internal equity and also may vary depending on the candidate's job-related knowledge, skills, experience, and location among other factors. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.
DisclaimerThis job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts management's right to assign or reassign duties and responsibilities to this job at any time.
Note to all external Recruiters & Staffing AgenciesAll of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.
