Research Associate 2, Discovery Technologies Senior Manager / Associate Director of Discovery and Development Program Management
DIRECTOR TOXICOLOGY

BRIS.133

UNITY biotechnology is committed to developing therapeutics to extend human healthspan by slowing, halting or reversing the diseases of aging.   Located in the heart of the biotechnology industry near South San Francisco, we are seeking a scientific leader to oversee Drug Safety efforts as Director of Toxicology.  The role will be involved in the design, execution, analysis, interpretation and communication of nonclinical safety studies of small molecule and biologics and their associated delivery system to provide nonclinical safety profile and risk assessment to support drug development.  This position requires strong intellectual leadership, working at the interface of discovery and development teams and will serve as the nonclinical subject matter expert. The incumbent will design, conduct, and interpret nonclinical toxicology and investigational safety studies; will advise management on the toxicological aspects of the project and will effectively communicate with worldwide regulatory agencies to bring our drugs to patients as quickly as possible. This is an ideal position for an independent individual with a strong background in discovery and preclinical toxicology who enjoys working in a team-oriented and highly cross-disciplinary environment.

Key Responsibilities:

  • Support our discovery group in the safety testing of lead compounds, including introduction of new testing paradigms
  • Design, supervise, interpret, and report in vitro and in vivo nonclinical toxicology IND enabling studies and studies supporting more advanced clinical stages.
  • Participate in the management of CROs/academic sites in the conduct of in vitro/in vivo safety studies and future potential to set up in-house laboratory capabilities
  • Participate in the preparation of preclinical dossiers for worldwide regulatory submissions, including authoring the nonclinical safety components of regulatory dossiers (e.g. IB, INDs, NDAs) and communications as well as responses to inquiries from regulatory agencies.
  • Work closely with internal functional groups such as Pharmacology, ADME-PK, CMC, Regulatory Affairs, Clinical Development, and Program Management, and actively participate in team strategy discussions for drug development programs.
  • Lead teams of preclinical experts in respective projects.
  • Responsible for providing non-clinical safety support to in-licensing review teams
  • Participate in the preparation of abstracts and manuscripts for publication

REQUIREMENTS:

  • DVM or PhD in pharmacology, toxicology, or related scientific discipline.
  • Board certification (DABT) is a plus.
  • 10+ years of relevant industry experience in toxicology, supporting drug discovery, research and development.
  • Proficient knowledge of general toxicology and related disciplines, with evidence of drug development experience. Experience in local delivery of therapeutics (ocular, pulmonary, intra-articular) is a plus
  • Experience with in vitro assays utilized in discovery and toxicological assessment.
  • Familiar with regulatory toxicology guidelines, requirements and standards (GLP, OECD, ICH, CTD, etc.) and able develop nonclinical strategies that support clinical development.
  • Experience in authoring nonclinical components of regulatory dossiers.
  • Independent self-starter with the ability to work in a matrixed, cross-functional, team-based drug discovery/development environment.
  • Excellent verbal and written communication skills; ability to communicate clearly and effectively with scientific colleagues and senior management.

Please send resume and cover letter