Associate Director / Director Preclinical Development
- Employer
- Cue Biopharma
- Location
- Cambridge, MA
- Start date
- Dec 23, 2020
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- Discipline
- Clinical, Clinical Development, Drug Safety/Pharmacovigilance, Science/R&D, Toxicology
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Genetown
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 diseases and autoimmune diseases. 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 to help us advance our research and development programs. The company culture is fast-paced and committed to scientific excellence, innovation, and teamwork.
Key Responsibilities
- Responsible for devising and overseeing execution of stage-appropriate bioanalytical and safety strategies as the strategic and scientific representative on project teams
- Design, initiate, and monitor internal and external safety testing together with external consultants
- Oversee internal teams, external vendors and collaborators to develop, qualify, transfer and validate bioanalytical assays to support discovery and development programs across Cue Biopharma's pipeline
- 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 bioanalytical assays and nonclinical safety assessment
Qualifications
- Ph.D. in Toxicology, Pharmaceutical Science or related field is required
- 10+ years of industry research experience and a track record of supporting advancement of novel therapeutic modalities into clinical testing
- Direct experience developing the data package supporting the clinical development of protein biologics preferred
- Firm understanding of bioanalytical methods and pharmacokinetics
- Track record of toxicology leadership on Oncology discovery and development programs
- Knowledge of GLP compliance and relevant ICH & FDA guidance documents
- Experience with IND preparation and submission, and regulatory interactions
- Ability to work well with external CROs and collaborators
- Ability to work effectively both independently and collaboratively in a fast-paced, dynamic team-oriented environment
- Ability to travel to monitor out-sourced studies as required and feasible
- Outstanding organizational skills with the ability to prioritize and deliver against timelines for multiple projects simultaneously
- Self-motivated, team- and goal-oriented scientist with excellent oral and written communication skills
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