Senior Clinical Program Manager/Associate Director, Clinical Operations

Ultragenyx Pharmaceuticals Novato , CA 94998

Posted 5 months ago

Why Join Us?

Be a hero for our rare disease patients

Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.

Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best because we never lose sight of our mission to make a difference in our patients' lives.

Come join our team during this exciting time of growth and opportunities!

Position Summary:

The Senior Clinical Program Manager (Sr. CPM)/Associate Director, Clinical Operations is accountable for the operational strategic planning, oversight and delivery for one or more assigned clinical programs. The Senior CPM/Associate Director is accountable for the line management of Clinical Operations staff, including development, coaching, talent planning and performance management. The Senior CPM/Associate Director also participates in functional governance, including resourcing and staffing. The core duties and responsibilities of the Senior CPM/Associate Director include, but are not limited to:

Responsibilities:

  • Lead the operational strategy and functional management for one or more clinical trial programs, in accordance with the Clinical Development Plans and program plans

  • Develop the study project plan, including timeline, metrics, budget, and resources

  • Lead the Clinical Operations team to ensure effective development, implementation and execution of clinical trials within agreed timelines, resources and budgets

  • Provide input on the development of protocols, Case Report Forms, Clinical Study Reports, and regulatory submissions, as appropriate

  • Participate in and/or facilitate CRO/vendor selection process for outsourced activities

  • Oversee CRO interactions, including sponsor oversight of operational functional activities, such as study management, training and monitoring

  • Represent Clinical Operations on the Development Sub-team

  • Identify program risks, develop and implement mitigation strategies for assigned programs

  • Prepare metrics and updates for management

  • Manage and mentor Clinical Operations staff

  • Ensure employees and contractors are appropriately trained to comply with company and regulatory standards

  • Participate in the development and implementation of corporate and department organizational goals

  • Participate in and/or lead working groups or initiatives, as required

  • Bachelor degree or equivalent required (scientific or healthcare discipline preferred)

  • 12+ years of progressively more challenging experience in clinical and drug development, including 5+ years of clinical trial management experience

  • 4+ years of experience in a supervisory role

  • Demonstrated ability to lead a development program and study teams

  • Working knowledgeable of FDA regulations and ICH GCP guidelines is required

  • Experience with international trials

  • Rare disease clinical trial experience desired

  • Ability to provide scientific and clinical expertise to a clinical development program

  • Working knowledge of FDA 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

  • Must have the ability to build and maintain positive relationships with management, peers, and direct reports

  • Excellent written and verbal skills required. Must display strong analytical and problem solving skills

  • Willing to travel domestically and internationally

#LI-TK1

Ultragenyx Pharmaceutical Inc. is an equal opportunity employer. We understand that diversity of thought, culture and background will help us do the best for our patients. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.


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Senior Clinical Program Manager/Associate Director, Clinical Operations

Ultragenyx Pharmaceuticals