Senior Director, Biometrics
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics. FivePrime has a differentiated discovery platform and capabilities that is fueling a growing portfolio of development candidates.
Our pipeline includes:
- Cabiralizumab (FPA008), an anti-CSF-1R antibody currently in development in a Phase 2 trial in pigmented villonodular synovitis (PVNS) and a Phase 2 trial in second-line pancreatic cancer
- Bemarituzumab (FPA144), an anti-FGFR2b antibody currently in a Phase 1/3 clinical trial in FGFR2b over-expressing gastric cancer
- FPA150, an anti-B7H4 antibody will enter Phase 1 clinical development in the first half of 2018
- FPT155, a CD80 fusion protein, which is in IND-enabling studies
We have entered into strategic discovery and development collaborations with leading pharmaceutical and biotech companies, including Bristol-Myers Squibb, GSK, UCB and Zai Labs.
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.
Reporting to the Chief Medical Officer, this position will be responsible for providing strategic input as it relates to program and portfolio decisions and will contribute significantly to the development and success of the Clinical Development team including enhanced use of innovative or novel trial designs or endpoints. This position will require hands-on application while building and developing the Biometrics team.
This individual will oversee the Biometrics function, ensure systems, capabilities and resources are in place that optimizes the design, conduct, analysis and interpretation of clinical and nonclinical data for each program. In addition, this individual will be accountable for overall management of the function such as planning and oversight of the budget, building a world class team and identifying technology needs or other gaps. Partner with other functional leaders from Clinical Science, Drug Safety, Regulatory Affairs, Research and others in support of the project teams and of the organization.
- Grow and develop a team, at a minimum consisting of biostatistics, clinical and statistical programming and clinical data management groups.
- Lead the Biometrics function with clarity of vision and purpose; provide leadership and oversight for all aspects of the function; facilitate knowledge sharing and creation, lead to best practice and improve overall quality and processes.
- Ensure that program development teams obtain sufficient strategic input and technical expertise on statistical methodologies for clinical and clinical pharmacology studies.
- Plan and execute a resource plan that supports the business; identify technology needs or other gaps; identify and communicate risks to the business and develop solution oriented approaches to address or mitigate risk; trouble-shoot responsibility by resolving critical issues that impact optimal functioning of the biometrics function.
- Ensure that we credibly communicate clinical trial data internally and to Health Authorities, the academic community, and healthcare providers, as appropriate. Ensure that the interpretation of data obtained from our trials, from trials conducted by our collaboration partners, CROs and competitive data is accurate, scientifically sound and credible.
- Provide strategic guidance to ensure high quality preparation of Regulatory Authority documents (clinical study reports, submissions, clinical protocols, safety reports, etc.).
- Oversee the continued optimization of a state-of-the-art, best practice systems for data management and programming.
- Lead change in the organization to continuously adapt to a dynamic and high growth environment; learn from and reflect on experiences and integrate and apply learning to enhance organizational performance.
- Participate in regular meetings of the Clinical Development Leadership Team, program and governance committees, in regular senior management meetings at the organizational level, and will contribute to initiatives of importance to Five Prime.
- Develop strong and collaborative work relationships with key business stakeholders (e.g. Project Team leaders, Asset Team Leaders, functional heads within Clinical Development, Research and others).
- Mentor and coach direct reports to maximize their potentials
- Other projects/ duties as needed.
- Ph D. in statistics or biostatistics required with minimum of 15+ years of experience in the pharmaceutical or biotechnology industry
- Prior management experience required
- Leadership experience with proven capability as a successful leader in a strategic multifunctional environment, highly skilled in leading change and people agility
- Strong business acumen and critical thinking
- Extensive knowledge of clinical trial development and statistical methodology related to trial design and conduct of clinical studies is required; experience in oncology is required
- Good knowledge of ICH, FDA, and GCP regulations and guidelines; strong well-rounded technical skill, SAS, SDTM, and CDISC
- Has scientific background and understanding of clinical trials, clinical development operations and regulatory compliance
- Extensive experience negotiating successfully with health authorities
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.