Senior Director, Clinical Sciences
- 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.
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.
The Medical Director will report to the Vice President of Clinical Development and matrix with members of the project team to assist in establishing the clinical development strategy for one or more compounds: from the pre-IND setting to pivotal trials and registration. Key aspects of the development strategy include study design, tissue sample collection, input to biomarker strategies, and integration of “personalized medicine” into the clinical development plan. The position is accountable for medical monitoring, patient safety and provision of medical guidance during the design, execution, and reporting of clinical studies and registration with health authorities.
Technical responsibilities required, but not limited to:
Lead the formulation of clinical development plans, including selection of the proof of concept indications for specific projects.
In collaboration with appropriate team members (e.g., clinical pharmacology, statistics, translational medicine, research), be responsible for the design of protocols and conduct of data review, analysis and interpretation.
Function in the role of medical monitor.
Ensure the medical and scientific quality of clinical trial protocols, case report forms, data and data listings, and clinical trial reports.
Be accountable for safety across relevant studies, including regular review of safety data (including but not limited to SAEs) and response to safety issues.
Work closely with CRO, Clinical Operations and investigators/investigative sites to ensure data quality and patient safety.
Maintain working knowledge of GCPs and regulatory requirements relating to clinical development and safety compliance with ethical, legal and regulatory standards.
Participate in proposal generation, feasibility assessments, and review of proposals/contracts for medical services.
Participate in the development and delivery of protocol training for investigator site and FivePrime staff.
In conjunction with the CMO and Research group, prepare strategy presentations, present and discuss data at relevant team, governance, executive committee, external consultant, OL, and regulatory meetings.
Author clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR).
Participate in preparation for and conduct of meetings with healthcare authorities.
Contribute to the overall strategy and preparation of documents to secure approval of drugs, e.g., BLAs/NDAs/MAAs.
Lead or assist in preparation of manuscripts, abstracts and meeting presentations.
In conjunction with Clinical Science and Operations, be responsible for the on-time and within-budget execution of protocols.
Other projects as needed
Requires MD with a minimum of 3-5 years of demonstrated knowledge and experience in clinical research, preferably in an industry setting.
Strong basic science knowledge to enable proof-of-concept and PD biomarker design and interpretation.
Oncology fellowship training and active board certification within the last 5 years.
Understanding of related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).
Demonstrated scientific productivity (publications, abstracts, etc.).
Scientific writing skills and good communication skills.
Flexibility to work with colleagues in a matrixed setting.
Able to engage in work-related travel approximately 20%.
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.
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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.