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Associate Director, CMC Program Management

Associate Director, CMC Program Management

Ultragenyx PharmaceuticalSan Francisco, CA, US
16 hours ago
Job type
  • Full-time
Job description

Associate Director, CMC Program Management

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.

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's CMC subteam to develop, maintain and execute the CMC strategy. The number of programs will depend on stage and scope of the programs.
  • Lead and develop the cross-functional integrated CMC plan including realistic but aggressive timelines, budget and resource planning, risk assessment and mitigation / contingency planning.
  • 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.
  • Responsible for monitoring and tracking the CMC plan against approved timelines and milestones and ensures adherence to agreed-upon team objectives and deliverables.
  • Manages prioritization of CMC subteam activities to enhance program value.
  • Acts as spokesperson for the CMC plan and may represent the CMC plan internally and externally.
  • 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.
  • Responsible for comprehensiveness and quality of CMC subteam information in the internal systems, databases, and communications to Senior Management and program team.
  • Expected to identify bottlenecks, surface issues, and proactively drive for their resolution.
  • Lead ad-hoc cross-functional task forces as needed aiming at issue resolution, scenario planning, and / or mitigation / contingency planning.
  • Consistently and effectively manage through ambiguity and abstract ideas or situations across functional areas
  • Ensure effective, proactive, and open communications, horizontally and vertically, to achieve transparency and clarity of CMC subteam goals, progress and issues.
  • Develop CMC PM departmental processes, procedures, and tools to improve CMC PM capability and portfolio management.
  • May support / lead / drive corporate policies and process improvements and ensure consistent implementation.
  • May supervise PCs / PMs / Sr PMs

Requirements :

  • Required advanced degree with minimum 8 years of industry experience.
  • 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.
  • Cross-functional team and relationship building skills.
  • 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.
  • 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.
  • Ability to critically and objectively interpret and evaluate scientific and competitive, business-related information.
  • Exercise latitude in determining objectives and approaches critical to CMC subteam
  • Must possess solid leadership skills including the ability to influence others in sensitive complex situations while maintaining positive relationships
  • 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
  • Strong verbal and written communications
  • The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location. This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.

    Pay Range $188,600 - $233,000 USD

    Full Time employees across the globe enjoy a range of benefits, including, but not limited to : 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. Benefits vary by region and country.

    Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity / expression, national origin / ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and / or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.

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