Manager, Clinical Procurement and Outsourcing - Novato, CA | Biospace
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Manager, Clinical Procurement and Outsourcing

Ultragenyx Pharmaceutical Inc.

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Location:
Novato, CA
Posted Date:
8/10/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Operations, Manager,

Job Description


Why Join Us?

Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.

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

We are headquartered in Novato, CA, 25 miles north of San Francisco, and we also have an office in Brisbane, CA, 10 miles south of San Francisco.

Position Summary:

The Manager, Clinical Procurement and Outsourcing will be primarily responsible for leading the activities related to the outsourcing of clinical services to service providers for one or more clinical programs in various stages of development. The successful incumbent will work closely with various internal team members and vendors to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets.

Responsibilities, including but not limited to:
•   Manages the RFP and vendor bidding process for one or more clinical procurement categories for our clinical development programs
•   Develops and executes implementation plans to ensure sourcing benefits are fully realized
•   Conducts an ongoing analysis of vendor performance using metrics, expectation requirements and KPIs to ensure compliance of contracted services
•   Proactively identifies potential vendor issues/risks and recommends/implements solutions
•   Leads budget and contract negotiations with Clinical Development service providers including all initial contracts and any change orders
•   Serves as point of contact to the clinical development vendors in resolving contract scope and budget issues
•   Participates in the development, review and implementation of departmental SOPs and processes
•   Recommends and implements innovative process ideas and tools to impact clinical procurement and outsourcing
•   Collaborates with cross-functional groups to ensure the most optimal strategies and solutions are achieved in alignment with departmental objectives and achieving best value

Requirements


•   A Bachelor of Science degree
•   A minimum of 5 years of related clinical outsourcing experience with at least 3 years of vendor contract negotiation and oversight responsibilities
•   Strong knowledge with advanced concepts of clinical research and able to work effectively in a team/matrix environment
•   Strong knowledge and experience in clinical operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required
•   Demonstrated capability of managing multiple external vendors for multiple clinical trials simultaneously

Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.