Associate Director, Clinical Programming
- 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 positions us to discover novel pathways and targets in immuno-oncology and will continue to generate important development programs. 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.
Five Prime is committed to innovation and outstanding science to develop effective new drugs for the treatment of severe diseases. We value our culture of openness, collaboration and productivity.
The company is in a strong financial position and has an effective executive team and Board of Directors. Discover more about FivePrime at www.fiveprime.com
We are seeking a highly motivated individual to join the Five Prime Therapeutics Inc. Clinical Data Management group. This position will be responsible for developing program specifications, programming listings and reports, developing and maintaining a library of clinical programs, and providing other clinical programming support across Clinical Development projects. This position will report into the Director of Clinical Data Management and Clinical Programming.
- Manage clinical programming timelines to coordinate and synchronize deliverables with overall study timelines/milestones
- Generate and distribute outputs to summarize clinical data management metrics, patient profiles, SAS data listings and reports across multiple studies/clinical programs
- Provide clinical programming support to the Clinical Development department in support of corporate goals and study objectives. Collaborate with business stakeholders
- Develop a standard library of data listings and corresponding specifications to support data quality review
- Contribute to the development of data standards in compliance with CDISC (CDASH/SDTM), and corresponding standard edit checks and data review listings.
- Review and contribute to the development of data transfer specifications
- Review clinical data transfers for consistency with available specifications and/or data transfer plans
- Generate reconciliation programs to ensure consistency between clinical data and external databases
- Proactively identify potential study issues/risks and implement solutions
- Participate in eCRF design/setup to ensure consistent data standard implementation
- Contribute to the development of SOPs and other department and/or cross-functional initiatives
- Contribute to decisions regarding the technical infrastructure of data management; collaborate with IT to ensure local IT infrastructure meets clinical data management needs and global standards
- Review clinical programing outputs generated at CRO or in-house for accuracy against specifications
- Develop and implement strategy for the improvement of productivity, e.g. programmatic efficiencies, and standardization of study builds, database setups and programming activities
- Manage and work directly with CROs used for clinical programming; provide guidance and monitor the progress of clinical programming activities with CROs and other vendors.
- Review and/or creation of SDTM specifications, annotated CRFs and datasets
- May mentor, recruit and/or manage additional clinical programming staff
- Bachelor degree in Life Science, Computer Science, or Mathematics
- Minimum of 10 years of clinical data management, electronic data capture (EDC), and clinical programming experience in the pharmaceutical/biotechnology or CRO industry.
- Solid experience with SAS programming
- Prior oncology experience strongly preferred
- Effective team player and ability to collaborate with cross-functional business stakeholders
- Ability to think strategically and offer unique programmatic solutions
- Demonstrated ability to work independently and manage complex projects with multiple priorities in a fast paced, team-based environment
- Excellent working knowledge of FDA & ICH/GCP regulations and guidelines
- Excellent working knowledge of CDISC standards (CDASH and SDTM) and CDM Best Practices
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.