Associate Director, Program Management, CMC

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

Ultragenyx is looking for an Associate Director with a passion and creativity to develop great medicines for rare and ultra-rare diseases. You will be a self-starter with excellent project management skills and the ability to build strong rapport across functions. You will be ready for a career defining experience and have the passion to drive several therapeutics for devastating diseases to final approval and launch.

You will report to the Director of Program and Portfolio Management and will be responsible for managing one or more programs depending on the stage and scope of a program within transitional research through commercialization stages.  In addition, this individual will actively support development of the department and tools/process across the portfolio.

We will assess your level based on your experience before moving forward with full panel interviews.

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

• Support the program team to develop, maintain and execute the CMC strategy for multiple research and development programs. The number of programs will depend on stage and scope of the programs.
• Directs and controls multiple CMC subteams that are cross-functional.
• Design, develop and manage project schedules for CMC subteams
• Lead and develops the cross-functional plans together including realistic but aggressive timelines, budget and resources planning, risk assessment and contingency planning.
• Ensures cross-functional alignment and organizational support for the execution of the program plan by facilitating internal and external stakeholder meetings.  Driving the team to ‘out-of-box” thinking and creative issue resolution.
• Lead and drives objective setting process for programs.
• Responsible for monitoring and tracking the project against approved timelines and milestones and ensures adherence to agreed-upon team objectives and deliverables.
• Manages prioritization of project team activities to enhance program value.
• Acts as spokesperson for the program and may represent program internally and externally.
• Responsible for comprehensiveness and quality of program information in the internal systems, databases, and communication to Senior Management and program team
• Expected to identify bottlenecks, surface issues, and proactively drive for their resolution. Leads contingency planning efforts.
• Conducts thorough assessment of intangible variables, fundamental issues, providing strategy and directions for multiple programs and/or initiatives
• Leads ad-hoc cross-functional task forces as needed aiming at issue resolution.
• Consistently works with abstract ideas or situations across functional areas
• Ensures effective, proactive, and open communications, horizontally and vertically, to achieve transparency and clarity of program goals, progress and issues.
• Develop departmental processes, procedures, and tools to improve departmental functioning and portfolio management.
• Supports/leads/drives corporate policies and process improvements and ensures consistent implementation.
• May be supervising PCs/PMs/Sr PMs
• Managing a portfolio of programs and/or initiatives

Requirements:

• Required advanced degree with minimum 8 years of industry experience
• At least 5+ years equivalent multi-/ cross-functional leadership experience in CMC late-stage development and commercialization of products. Experience with biologics and /or gene therapy preferred.
• Advanced level of science and clinical acumen.  Experience working in genetic, rare diseases preferred.
• Cross-functional team and relationship enhancing skills
• Previous work and leadership experience in international and multidisciplinary drug development teams and broad operational experience with an experienced understanding of drug development process
• In-depth knowledge of CMC needs for preclinical, clinical, regulatory, and commercial functions, as well as business strategy and business requirements.
• Outstanding Project Management skills, including expertise in designing, developing, and managing project schedules and resource management.
• Understands financial aspects, including knowledge of resource planning (headcount and budget) and management
• Ability to critically and objective interpret and evaluate scientific and competitive, business-related information.
• Exercise wide latitude in determining objectives and approaches critical to program/organization; requires minimal program strategic direction needed from Vice President
• Strong interpersonal, communication, and negotiation skills for bridging between scientific and business participants, for negotiating timelines and for effective collaboration, with internal and external executive-level management #LI-CS1 #LI-Hybrid