Associate Director/Director, Translational Medicine
Cue Biopharma, Inc., a clinical-stage biopharmaceutical company, is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body to transform the treatment of cancer, infectious disease and autoimmune disease. Cue Biopharma is a high growth company and is listed on NASDAQ (CUE). The company is located in Cambridge, Massachusetts in the heart of the life sciences corridor.
Cue Biopharma is building a world-class team of highly motivated, dedicated scientists and clinical personnel to help us advance our research and development and clinical programs. The company culture is fast-paced and committed to scientific excellence, innovation, and teamwork.
- Develop and implement clinical biomarker and patient stratification testing strategies for clinical trials, collaborate with clinical team on all aspects of clinical assay development and operations and communicate translational strategies and findings internally and externally.
- Oversee external vendors, internal teams and collaborators to develop, qualify, transfer and validate clinical assays to support development programs across Cue Biopharma’s clinical pipeline.
- Conduct and oversee analyses of translational biomarker samples in support of clinical studies.
- Identify pharmacodynamic assays for utility in preclinical and clinical settings, and help define PK/PD/efficacy relationships.
- Author and review technical reports and summary documents for regulatory filings as well as relevant sections of clinical documents, scientific presentations and publications.
- Maintain knowledge of regulatory expectations and industry standards for clinical biomarker assays.
- Ph.D. or equivalent advanced biology degree with 10+ years of experience.
- Hands-on experience in the design and generation of clinic-ready biomarker assays.
- Experience leading biomarker testing in clinical trials for oncology and/or immunology drug development.
- Strong understanding of biomarker technologies with specific technical expertise in flow cytometry, IHC, or ex vivo culture preferred.
- Experience with preparation of regulatory and clinical documents.
- Strategic thinker with excellent verbal and written communication skills.
- Ability to work well with external CROs and collaborators, both independently and collaboratively in a fast-paced, dynamic team-oriented environment.
- Outstanding organizational skills with the ability to prioritize and deliver against timelines and budgets for multiple projects simultaneously.
- Self-motivated, team- and goal-oriented scientist with excellent oral and written communication skills.
To apply, please email your resume to firstname.lastname@example.org. In the subject line include your name and the posted job title.« Go Back