Associate Director / Director Preclinical Development

Location
Cambridge, MA
Posted
Dec 23, 2020
Ref
727435586
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time

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