Clinical Outsourcing Manager/Senior Clinical Outsourcing Manager

Location: South San Francisco, CA
Position type: Full-time
 

Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a biotechnology company discovers and develops innovative therapeutics to improve the lives of patients with serious diseases.  Five Prime's comprehensive discovery platform, which encompasses virtually every medically relevant extracellular protein, positions it to explore pathways in cancer, inflammation and their intersection in immuno-oncology, an area with significant therapeutic potential and a growing focus of the company's R&D activities. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and late preclinical development. For more information, please visit www.fiveprime.com.

The Position

Five Prime is seeking a results-driven Manager or Senior Manager, Clinical Outsourcing to oversee key activities related to the outsourcing of clinical trials with an emphasis on service provider selection, contract negotiation, financial and relationship management of clinical service providers across multiple global clinical development studies and programs. This position will report into Director of Clinical Business Operations.

Responsibilities include but are not limited to the following:

  • Manage the clinical outsourcing activities within the Clinical Operations group as well as for serving as a working clinical outsourcing manager.
  • Partner with study execution team (SET) lead and team members to determine what service providers are needed and creating specifications for work to be outsourced; identifying potential service providers based on capabilities, capacity, strategic fit, expertise, quality, performance and price.
  • Independently manage the request for proposal (RFP) process (including service provider evaluation and selection) for clinical service provider (e.g. CROs, central labs, imaging service providers, PRO vendors, specialty labs, and other clinical vendors) needs for FivePrime clinical studies across all phases. This includes driving timelines for the timely selection of service providers and leading the SETs through the process of reviewing and analyzing service provider proposals, including budgets, bids, and outsourcing models to optimize service provider selection.
  • Manage review and negotiation of contract business terms in partnership with Legal, Finance and other internal stakeholders as needed to ensure the timely execution of agreements.
  • Lead financial negotiations with external clinical service providers including analysis of detailed scopes of work, exhibits, payment terms and schedules, and significant budgets.
  • Lead FivePrime negotiations on master service agreements and rate cards, if warranted, for assigned programs.
  • Serve as primary point of contact to the CROs and clinical service providers to resolve contract scope and financial matters for assigned programs.
  • Ensure timely development of costs estimates for changes in scope of work, negotiating and timely implementing change orders in partnership with SET leads and/or team members.
  • Partner with SET leads and/or team members to manage service provider relationships and to oversee service provider performance (including financial relationship management) to ensure compliance against contracted services for outsourced work and managing or escalating issues as appropriate.
  • Participate in internal study team meetings as well as teleconferences with service providers and study personnel when applicable.
  • Implement, track and review key performance indicators for service provider contracting and perform quality control on those metrics to ensure accuracy, and present those metrics to management.
  • Ensure that all negotiations and contracting are conducted in compliance with FivePrime policies and legal requirements.
  • Optimize outsourcing contracting processes and relationship management with clinical service providers by developing and implementing clinical outsourcing best practices, standards, processes, policies, and associated documents.
  • Stay abreast of industry developments in the Clinical Outsourcing Management field and apply to appropriate systems or processes.
  • Partner with management to develop short- and long-term resource allocation plans and contribute to functional budget. 

Education and Experience

  • B.S. or B.A. required, MBA, M.S. or M.A. preferred
  • 7+ (manager) /10+ years’ (senior manager) experience in clinical outsourcing management at a biotechnology company or CRO, oncology experience preferred
  • Proven expertise and experience in contract negotiation and management (budgets and business terms and conditions) for clinical service providers (CROs and other key clinical service providers) required
  • Proven ability to analyze and synthesize information to understand issues, identify options and support sound decision making
  • Professional attitude and excellent interpersonal skills; proven ability to build and maintain collaborative, effective internal and external relationships
  • Excellent analytical, negotiation and business communication skills
  • Ability to work with cross functional teams and facilitate communication with internal/external stakeholders. Ability to work with people across varying levels of responsibility within FivePrime and with service providers.
  • Demonstrated ability to work independently to prioritize and manage complex projects with multiple priorities in a fast paced, team-based environment
  • Attention to detail
  • Proficient with word processing, spreadsheet and database software, and clinical and financial systems.
  • Sound background in financial/controlling issues

Please upload your cover letter and resume.

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