Associate Director, CMC Program Management

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

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

This position will report to the Executive Director of Program and Portfolio Management and will be responsible for managing two or more program specific CMC subteams depending on the stage and scope of a program from Phase 3 through launch and commercialization stages.  In addition, this individual will actively support development of the CMC PM capability and tools/process across the portfolio. 

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:

1. Support the program’s CMC subteam to develop, maintain and execute the CMC strategy. The number of programs will depend on stage and scope of the programs. 
2. Lead and develop the cross-functional integrated CMC plan including realistic but aggressive timelines, budget and resource planning, risk assessment and mitigation/contingency planning. 
3. Ensure cross-functional alignment and organizational support for the execution of the CMC plan by facilitating internal and external stakeholder meetings.  Driving the team toward ‘out-of-box” thinking and creative issue resolution. 
4. Responsible for monitoring and tracking the CMC plan against approved timelines and milestones and ensures adherence to agreed-upon team objectives and deliverables. 
5. Manages prioritization of CMC subteam activities to enhance program value. 
6. Acts as spokesperson for the CMC plan and may represent the CMC plan internally and externally. 
7. Communicate and collaborate effectively with Program Manager and other functional PMs to ensure integration and delivery of CMC deliverables with the rest of the program. 
8. Responsible for comprehensiveness and quality of CMC subteam information in the internal systems, databases, and communications to Senior Management and program team. 
9. Expected to identify bottlenecks, surface issues, and proactively drive for their resolution. 
10. Lead ad-hoc cross-functional task forces as needed aiming at issue resolution, scenario planning, and/or mitigation/contingency planning. 
11. Consistently and effectively manage through ambiguity and abstract ideas or situations across functional areas 
12. Ensure effective, proactive, and open communications, horizontally and vertically, to achieve transparency and clarity of CMC subteam goals, progress and issues. 
13. Develop CMC PM departmental processes, procedures, and tools to improve CMC PM capability and portfolio management. 
14. May support/lead/drive corporate policies and process improvements and ensure consistent implementation. 
15. May supervise PCs/PMs/Sr PMs 

Requirements:

1. Required advanced degree with minimum 8 years of industry experience. 
2. Minimum 5 years of multi-/ cross-functional leadership experience in CMC late-stage development and commercialization of products.  Experience with biologics and /or gene therapy preferred.  Experience working in genetic, rare diseases preferred. 
3. Cross-functional team and relationship building skills. 
4. Advanced level of science and CMC acumen.  In-depth knowledge of CMC needs for preclinical, clinical, regulatory, and commercial functions, as well as business strategy and business requirements. 
5. Outstanding Project and Program Management skills, including expertise in designing, developing, and managing CMC project schedules, and experience delivering on CMC financial, resource, and risk management. 
6. Ability to critically and objectively interpret and evaluate scientific and competitive, business-related information. 
7. Exercise latitude in determining objectives and approaches critical to CMC subteam 
8. Must possess solid leadership skills including the ability to influence others in sensitive complex situations while maintaining positive relationships 
9. 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 
10. Strong verbal and written communications 

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