Senior Manager, Clinical Procurement and Outsourcing - Brisbane , California, United States, 94005
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!
ultrainnovative - Tackle rare and dynamic challenges
The Sr. Manager, Clinical Procurement and Outsourcing will be primarily responsible for leading the activities related to the outsourcing of clinical services to Clinical Research Organizations (CROs) and other 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:
* Manage the RFP process, including vendor identification, bid comparison analysis, bid defense, and contract negotiation and finalization for Clinical Development
* Lead budget and contract negotiations with Clinical Development service providers including all initial contracts and any change orders
* Negotiate final scopes of work, budget, and payment schedules with input from functional stakeholders for clinical study service providers
* Coordinate contract terms/conditions review, approval and signature process with external parties and internal stakeholders and act as central point of contact through approvals and execution
* Negotiate and execute new MSAs as needed. Maintain and manage existing MSAs, including amending agreements in relation to new business needs or changes in circumstances
* Serve as primary point of contact for CROs and clinical development vendors in resolving contract scope and budget issues and managing and work with other team members to escalate issues accordingly
* Contribute to development of process development/improvement, and implementation of processes and tools related to outsourcing activities
* Liaise with internal colleagues on budget related questions as they apply to clinical contracts, participate in monthly/quarterly accrual process and provide budget information for financial planning and forecasting
* Participate in study management meeting for assigned categories
* Track negotiated cost savings and cost avoidances achieved
* Collaborate with cross-functional groups to ensure the most optimal strategies and solutions are achieved in alignment with departmental objective to achieve best value
* Conducts an ongoing analysis of vendor performance using metrics, expectation requirements and KPIs to ensure compliance of contracted services
Technical Requirements & Skills:
* A Bachelor of Science degree preferred
* A minimum of 8 years of related clinical outsourcing experience with at least 5 years of CRO and 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
* Ability to deal with time demands, incomplete information or unexpected events
* Must be innovative, driven and effective with a "can do" attitude
* Must possess excellent interpersonal skills
* Must have the ability to build and maintain positive relationships with management, peers, and cross functional colleagues
* Excellent written and verbal skills required. Must display strong analytical and problem solving skills. Attention to detail required.
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: .