Clinical Outsourcing Manager
- 111 Oyster Point Blvd, South San Francisco, CA 94080, USA
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a publicly traded, clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to improve the lives of patients with serious diseases.
We have an industry-leading and differentiated drug discovery platform. Our comprehensive proprietary libraries of the extracellular proteome, differentiated screening capabilities and protein therapeutic generation and engineering capabilities comprise a unique and powerful IND engine that will continue to generate important development programs. This uniquely positions us to discover novel pathways and targets in immuno-oncology.
Our success with our drug discovery platform has led to a pipeline that is on track to more than double to five development programs in clinical trials across multiple indications in 2018. We also have several undisclosed research programs at different points of the target validation and molecule generation phases that have the potential to yield our next wave of development-stage therapeutic biologics. And we continue to fuel this process at the earliest stages with new screens planned this year.
FivePrime is committed to innovation and outstanding science, values that are reflected in our people and our products. Discover more about FivePrime at www.fiveprime.com.
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 Senior Director of Clinical Operations.
Responsibilities include but are not limited to the following:
- Manage the clinical outsourcing activities within the Clinical Development group
- 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 Five Prime 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 Five Prime 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 Five Prime 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 the functional budget.
- 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 Five Prime 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
At FivePrime, we believe a diverse workforce drives our success as a company. We are always working to create an environment where different backgrounds and viewpoints are valued and celebrated.
FivePrime is an equal opportunity employer. FivePrime makes employment decisions, including in recruitment and selection, without consideration of race, color, national origin, religion, sex, gender, gender identity or expression, sexual orientation, age, veteran status or disability.Please call or reply with any comments.
Five Prime acknowledges that providers may be a valuable resource for identifying and recruiting candidates for employment. However, we require that all recruiters engage directly with Five Prime’s Talent Acquisition Team and comply with Five Prime’s requirements prior to transmitting any resumes/CVs or introducing any candidates to Five Prime. Five Prime’s Talent Acquisition Team is the only function within the Company that can enter into contractual relationships with external recruiters and recruiting agencies. As such, all unsolicited resumes, CVs, anonymous profiles, or candidate information you may submit to employees of Five Prime will become property of Five Prime and Five Prime will have no obligation to pay you or anyone else for the use of such information, including any finder’s, placement, introduction or placement fee.