Associate Director, Disease Monitoring Programs – Metabolic

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🔥 12 minutes ago

🇺🇸 United States – Remote

💵 $187.3k - $231.3k / 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

• Process optimization and execution in providing real world evidence to key stakeholders including patients, providers, researchers, and patient advocacy groups • Ensure evidence strategy alignment throughout the development cycle for a program and across functions • Implement best practices for one or more assigned DMPs to monitor key deliverables (e.g. evidence generation, achievement of goals, financial health) • Provide input on the development of protocols, goals and endpoints tables, case report forms, IEPs, publications, Steering Committees and other relevant deliverables • Represent the DMP S&M function on the project teams, such as the Development Sub-Team, Core Teams (as applicable), etc • Train and mentor cross-functional personnel working on DMPs as needed

🎯 Requirements

• Bachelor degree or equivalent required (scientific or healthcare discipline preferred) • 7+ years of progressively challenging experience in clinical research and/or drug development • Critical thinking skills coupled with innovative approaches to problem solving • Comfortable managing and presenting to senior level stakeholders • Comprehensive understanding of high-quality data generation appropriate for regulatory, scientific, payer, physician and patient requirements to advance the understanding of rare diseases and their treatment/management • Ability to provide operational expertise to a clinical development program • Working knowledgeable of regulatory agency regulations and ICH GCP guidelines is required • Familiar with advanced concepts of clinical research (including complex study designs) and able to work effectively in a team/matrix environment • Strong strategic planning and decision-making skills • Ability to deal with time demands, incomplete information or unexpected events • Excellent written and verbal skills required. Must display strong analytical and problem solving skills. • Willing and able to travel domestically and internationally • Rare disease clinical trial experience desired

🏖️ 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