Director, Molecular Diagnostics Program

Why Join Us?   Be a hero for our rare disease patients   At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.    Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.   If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultraimpact – Make a difference for those who need it most

The Molecular Diagnostics Programs - Director will develop and manage diagnostic programs in support of timely and accurate diagnosis of rare disease patients. This is key role in Global Medical Affairs that contributes to the strategic vision and objectives of the team. The Director, Molecular Diagnostics Programs requires the integration of technical, genetic, and diagnostic expertise with program data to recognize and communicate program and scientific insights. The Director collaborates internally with Medical Affairs, Publications, Bioinformatics, Commercial, Regulatory, Legal, and other business functions for program execution. Successful candidates have a history of effective collaboration with cross functional teams in a matrix environment, engagement with external stakeholders and clinicians regarding diagnostic testing, experience with molecular, biochemical, or diagnostic commercial test development.

Work Model: 

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

 

Responsibilities:

• Provide Molecular Diagnostics Programs testing solutions for franchise and pipeline programs and patients.
• Drive for clarity on testing program requirements and anticipate the needs of medical and commercial teams, drawing on expertise in diagnostic, molecular, and/or biochemical laboratory testing
• Support global operational planning and execution for clinical laboratory testing programs based on experience testing program launches and by partnering with internal and external scientific, laboratory, and clinical director experts to inform patient diagnosis needs and program success
• Lead cross-functional marketed-product stage diagnostic testing program workstreams for one or more program and in two or more geographies
• Monitor and report on molecular diagnostics program status to the business
• Develop internally and/or externally facing laboratory testing program-associated materials, maintain medical and compliance review of such materials
• Support development and maintenance of gene locus-specific databases in partnership with internal teams and external submitters
• Analyze sponsored diagnostic program data, develop program summaries, and suggest program insights for internal and external publication and scientific exchange
• Provide subject matter expertise through training on molecular diagnostics programs as well as reviews of relevant program materials
• Uses diagnostic acumen and understanding of Ultragenyx priorities to identify strategic needs in rare disease diagnosis among commercial clinical laboratory offerings, working seamlessly with internal & external partners to co-develop and implement program-specific solutions

Requirements:

• Master’s or PhD in: genetics, biochemistry, genetic counseling, molecular biology or related field and >10 years industry experience
• Experienced in commercial genetic, biochemical, and/or other diagnostic assay development and testing program operational execution
• Demonstrated ability to successfully manage competing priorities & deliverables in a fast-paced, dead-line oriented environment
• Superior organizational, problem solving, and analytical skills
• Able to build