Sr. Director, Integrated Evidence Generation Lead

Responsibilities:
- Develop and maintain integrated Evidence Generation Plans (IEGPs) across the oncology portfolio aligned to lifecycle management objectives.
- Identify/prioritize evidence gaps across clinical, economic, and real-world settings; translate objectives into evidence-generation initiatives.
- Partner with Clinical Development, Commercial, and Market Access to align evidence strategy with product differentiation and value demonstration goals.
- Serve as a matrix leader across Medical Affairs, Clinical Development/Operations, Biostatistics/Data Science, Market Access/Health Economics, Commercial/Marketing, Legal/Compliance, and Alliance/Business Development; facilitate governance and decision forums.
- Drive study alignment (priorities, timelines, deliverables) with internal and external partners.
- Design and oversee observational studies (retrospective cohorts, pragmatic trials, external controls, registries, claims/EHR/oncology datasets, molecular/genomics registries, patient-reported data).
- Lead protocol and analysis plan development; provide scientific/epidemiologic oversight; ensure rigor and appropriate use of real-world endpoints (e.g., real-world PFS/OS).
- Oversee Early Access Programs (EAPs) and manage compassionate/expanded access activities.
- Lead Investigator-Sponsored Research (ISR) programs (governance, review committee coordination, proposal evaluation, budgets/contracts, compliance).
- Manage end-to-end delivery (vendor/CRO/analytics oversight, timelines, budgets, GCP/ICH, data privacy).
- Interface with regulators, payers, and HTA bodies; prepare briefing documents; participate in meetings.
- Represent the company externally in scientific forums and collaborations.

Qualifications (Required/Preferred):
- Advanced degree (PhD/MD/PharmD/DrPH/ScD) preferred in epidemiology, biostatistics, oncology, public health, or related; MPH/MS acceptable with additional experience.
- Director: 8–12 years evidence generation/epidemiology/outcomes/HEOR with 5+ years in oncology; Senior Director: 12+ years with leadership of enterprise-level RWE programs.
- Proven track record designing/delivering RWE/observational studies supporting regulatory, label, market access/reimbursement, and/or clinical development (pre/post-approval).
- Deep oncology endpoint/treatment paradigm knowledge (NSCLC preferred).
- Familiarity with major RWD sources (EHR/oncology EHR, claims, molecular/genomic/clinical registries) and data linkage.
- Hands-on advanced epidemiologic/causal inference experience; comfort partnering with quantitative teams.
- Vendor/CRO and multi-disciplinary team management; strong project and budget management.
- Strong written/oral communication; publication/conference record preferred.
- Ability to interact with regulators, payers, KOLs, and external collaborators; travel as needed.

Benefits:
- Competitive base salary, bonus, and equity plans; unlimited vacation and 10 sick days annually; medical, dental, vision; 401(k) with company matching.

Application instructions:
- Not specified in the provided text.