Senior Director, Evidence Generation

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $254.2k - $314k / year

⏰ Full Time

🟠 Senior

👔 Director

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Ultragenyx

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2010

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Ultragenyx is a biopharmaceutical company dedicated to transforming the lives of individuals with rare and ultrarare genetic diseases. The company focuses on developing and delivering treatments for conditions where no current therapies exist, utilizing a variety of drug modalities tailored to each disease. Ultragenyx boasts a robust and diverse clinical pipeline, with therapies in development for genetic diseases such as Wilson Disease, osteogenesis imperfecta, and Angelman Syndrome. With a passionate team and a commitment to patient advocacy, Ultragenyx aims to lead the way in pioneering therapies that significantly impact rare disease communities.

📋 Description

• Define and lead the framework, standards, and operating model for integrated evidence generation, including processes and cross-functional ways of working, to enable consistent, high-quality development and execution of Integrated Evidence Plans (IEPs) across programs • Partner with Global Medical Leads and cross-functional teams to support development of IEPs and align on medical evidence generation approaches • Translate IEP priorities into execution-ready evidence generation plans, including study concepts, protocols, data sourcing strategies, analytical approaches, and input into Disease Monitoring Programs (DMPs) • Lead and coordinate evidence generation activities (e.g., RWE studies, registries, chart review studies, natural history studies) and contribute to DMP strategy and design, in collaboration with cross-functional stakeholders, clarifying roles and responsibilities for execution as operating models evolve • Serve as an internal subject matter expert on real-world data (RWD) and real-world evidence (RWE), providing strategic guidance on data source selection, methodological approaches, and application of RWD/RWE to inform evidence generation and decision-making • Establish and advance structured data planning approaches and enable selection of fit-for-purpose data sources (e.g., EMR, claims, registries, PROs, and DMP-derived data), ensuring consistency, quality, and utility of data across programs • Lead and guide the analysis, interpretation, and dissemination of data generated from prioritized evidence generation activities, including DMP outputs, to support publications, scientific communications, and post-marketing and real-world evidence activities supporting regulatory, payer, and clinical decision-making • Implement and evolve enterprise-level processes and KPIs to support prioritization, tracking, and delivery of evidence generation activities, and partner cross-functionally (Clinical, HEOR, Regulatory, Market Access) and with external researchers and academic partners to ensure alignment with IEP priorities and evidence generation objectives; participate as a subject matter expert in IST/IIR/CR review processes

🎯 Requirements

• Advanced degree (PhD, PharmD, or equivalent) • 12+ years of experience in Medical Affairs, Clinical Development, Epidemiology, HEOR, or Evidence Generation • Proven experience designing and executing real-world evidence, observational studies, registries, or non-interventional research • Deep expertise in integrated evidence planning and evidence generation strategy • Strong background in rare diseases or small population research preferred • Demonstrated leadership of cross-functional global teams • Experience establishing governance models, operating frameworks, and scalable processes • Expertise in externally sponsored research (ISR/IIR/CR) programs and partnerships • Strong analytical, strategic thinking, and scientific communication skills • Experience aligning evidence generation with medical affairs, regulatory, HTA, and market access needs

🏖️ Benefits

• Generous vacation time and public holidays observed by the company • Volunteer days • Long term incentive and Employee stock purchase plans or equivalent offerings • Employee wellbeing benefits • Fitness reimbursement • Tuition sponsoring • Professional development plans