Clinical Trial Manager - Regional Lead
- 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.
We are seeking a highly motivated individual to join the Clinical Operations group. This position is responsible for leading the cross-functional study execution team (SET) and is accountable for managing the full scope of clinical trial(s), coordinating cross-functional team and vendor efforts, and ensuring the clinical trial(s) is initiated efficiently and completed on time, within budget and in compliance with SOPs, regulations, ICH/GCP guidelines, and in accordance with the Clinical Development Plan (CDP).
- Support cross-functional Study Execution Team(s) (SET) to ensure Five Prime clinical trials are initiated efficiently and completed on time
- Provide operational expertise and partner with the SET and SET lead to ensure that scientific objectives of the clinical studies are met and are within budget
- Provide input/ guidance to team on the day-to-day operational implementation activities of Phase 3 clinical study and extended access study
- Proactively identify study-specific risks and implement solutions. Effectively communicate study status, risks, and changes that may impact quality, timelines, and cost to internal and external stakeholders
- Ensure finalization of project and study related documents including protocols, IBs, informed consent forms, annual reports, and clinical study reports
- Develop and implement study management plans and vendor oversight plans. Provide direction to and oversight of CROs and vendors to ensure delivery against scope of work, KPIs, KRIs, and study management plans
- Manage study CROs and vendors (e.g., IxRS, Central and Specialty labs), including negotiation of scope of work and budgets
- Partner with SET, SET Lead and program lead on identified potential site issues. Follow-up accordingly
- Assist investigator meeting planning and execution
- Design training and deliver training to sites, vendors and internal staff on study protocol and processes.
- Develop metrics to measure training effectiveness and provide continuous improvement.
- Disseminate findings to study team and external partners, accordingly
- Work with external partners and sites to ensure that clinical data from a variety of sources is appropriately captured, monitored, source-verified, edit-checked, reconciled, and of high quality to meet trial’s objective
- Manage study budget and review of vendor invoices against scope of work. Partner closely with the study and program lead to ensure accurate accruing of study costs and forecasting of study budget. Foresee and communicate contracting/scope changes to study and program lead accordingly.
- Partner with Contracts department on the development of site budget and CTA templates.
- Lead budget negotiations with sites based on defined parameters and fair market value.
- Partner with Data Management to design and develop of eCRFs, monitoring conventions, and edit checks. Oversee implementation of study systems (e.g., CTMS, eTMF, eCOA, IxRS)
- Partner with Clinical Supply to forecast IMP and determine clinical trial supplies required for trial execution
- Participate in and may lead department process improvement initiatives and system implementation
- Other projects when assigned
- BS/BA in Life Science or related discipline
- 4+ years of experience in clinical and drug development
- Global clinical trial and CRO management experience in Phase 3 oncology is preferred
- Experience managing global sites is preferred - Asian & European site management experience desired
- Proven ability to successfully plan, implement, and manage global clinical trials independently
- Ability to manage cross-functional clinical study teams to high performance
- Proven ability to effectively manage CROs and clinical study vendors
- Ability to negotiate with vendors and teams
- Strategic thinking skills
- Agility and flexibility
- Strong working knowledge of FDA & ICH/GCP regulations and guidelines
- Highly effective interpersonal, written communication and presentation skills
- Excellent judgement and decision-making skills
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.