The (Senior) Director Translational Research will lead a team of researchers focusing on translational experimentation and analytics for our discovery research, preclinical and clinical programs. This position will include oversite to direct and integrate bioinformatics approaches preclinically and clinically, the discovery, validation, and implementation of biomarkers to be used in clinical trials, building strong scientific and pharmacologic rationale for numerous programs by utilizing patient-derived samples that can be utilized in regulatory filings, and oversite of in-vivo pharmacology studies that help to inform on indication prioritization. This position will collaborate with the CMO organization (Translational Medicine physician, Clinical Development, Clinical Operations, Regulatory groups) and Corporate Development organization (portfolio planning)
- Design and execute cross functional translational research studies supporting and bridging preclinical and clinical development of AnaptysBio’s inflammation and immuno-oncology programs.
- Conduct analyses of biological pathways to establish relevance to disease indications of interest to AnaptysBio’s therapeutic focus.
- Develop all the preclinical patient-related studies required for optimal characterization of pharmacology.
- Develop guidelines for selection, validation, and prioritization of translational biomarkers, ensuring alignment with AnaptysBio’s product development strategies.
- Work with Program Management to support program teams timelines and budgets
- Participate in new target identification, including translational biology assessment of emerging biology within therapeutic areas of strategic interest to AnaptysBio
- Establish and maintain a network of external experts for molecular and biological target identification and validation
- Will oversee an integrated approach to conducting in-vivo pharmacology studies externally.
- Contribute to the preparation of documentation required for regulatory submissions, including INDs.
- PhD and/or degree and expertise in immunology / autoimmunity/rheumatology
- (i.e. 15+ years of relevant, direct experience in preclinical/clinical development up to Phase 1 clinical studies,)
- Proven experience in the translational medicine approach to the development of biologics
- Technical credibility and expertise in Translational Biology; including hands-on experience working closely with research biology group to help progress molecules through preclinical development into the clinic.
- Capable of providing leadership in a cross functional team across Research and Clinical Development, without direct reports
- Strong management skills with 5+ years managing a team or group of scientists, and experience leading multi-disciplinary teams.
- Provides guidance to the scientific team responsible for the discovery and implementation of PD assays and biomarkers
- Provides guidance to the scientific assessment of MOA and indication selection
- Provides guidance to the implementation of PD assays, biomarkers, and efficacy endpoints in clinical development
- Provides guidance to specific trial design and demonstration of drug activity
- Excellent leadership skills and proven ability to work within multi-disciplinary teams to influence the overall direction of projects.
- Prior experience of working across diverse therapeutic areas is highly desirable.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
$150,000-$250,000, Stock Options & RSUs, 10% 401k