The Translational Medicine physician should be a bridge/liaison between clinical development and other areas of the organization including research and portfolio planning, with the primary focus on clinical strategies, trial design and endpoint development, data collection and analysis to support optimal drawn on data from real world settings to optimize probability of success of clinical studies in medically and commercially viable markets This position will collaborate closely with the Research organization (immunology and translational research groups), to identify, implement/integrate biomarkers, filter/understand/apply preclinical and animal models into disease/target identification for healthy volunteer and early POC disease studies that help validate target signals in disease and thus to progress programs toward larger phase 2/3 clinical development, integrating blood and tissue biomarkers and clinical endpoints.
- Design cross functional translational clinical development studies supporting and bridging preclinical and clinical development of AnaptysBio’s inflammation and immuno-oncology programs
- Develop guidelines for selection, validation, and prioritization of translational biomarkers, ensuring alignment with AnaptysBio’s product development strategies.
- Work closely with external research collaborators and contractors (CROs) for preclinical and clinical translational efforts.
- Explore biomarker identification/validation and interface with the discovery and development teams throughout the development process.
- Represent development projects at management meetings as well to external stakeholders.
- 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
- Participate in the design and execution of clinical studies leading to proof of concept.
- Contribute to non-clinical and clinical study design, data generation and reporting, regulatory document preparation, regulatory interaction and submissions.
- MD or PhD/MD physician with extensive experience in Inflammation and Immunology (i.e. 10+ years of relevant, direct experience in preclinical/clinical development up to Phase 2 clinical studies,)
- Proven track record in the translational development of drug candidates to include drug treatment approaches.
- Hands-on experience working closely with research biology group to help progress molecules through preclinical development into the clinic.
- Ideally a “thought leader” regarding the immunology of immune disorders and numerous MOA/cell types involved
- Solid working knowledge of pharmaceutical discovery and research.
- Strong project management skills with the ability to deliver results on schedule in a fast-paced, entrepreneurial environment.
- Prior experience of working across diverse therapeutic areas is highly desirable.
- Proven track record of making major contributions to the discovery of one or more marketed or in-development medicines.
- Sound theoretical and experimental background in biology coupled with a solid foundation in translational biology in the context of human diseases.
- Direct experience and knowledge of all the requirements needed to progress to first-in-human studies.
- Excellent leadership skills and proven ability to work within multi-disciplinary teams to influence the overall direction of projects.
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.