Job description
Director of Safety
Our client is seeking a Director of Nonclinical Safety and Toxicology. This position will be based either in Greater Boston or in the EU. This individual will be responsible for serving as a Project Safety Representative for Toxicology and Safety Pharmacology efforts, supporting multiple programs across multiple disease indications and research areas.
About the Company
This is a small-molecule company developing RNA therapeutics in areas of Oncology, Neuroscience, and others. They have a proprietary platform that efficiently accelerates the discovery and development of small molecule RNA targeting drugs by leveraging their RNA. They are a clinical stage company and have strong partnerships with large pharma.
Responsibilities
- Serve as Project Safety Representative on early Discovery through Phase 1 projects, including, but not limited to, the critical evaluation, risk assessment, and communication (including authorship of FIH-enabling regulatory documents) associated with nonclinical safety data and contribution to overall program strategy
- Design, oversight, and monitoring of outsourced nonclinical safety studies for assigned projects, including interaction and communication with key CRO partners
- Responsible for target safety assessments and contributing to investigative toxicology efforts
- Effectively collaborate with members of the scientific team and external consultants to generate a nonclinical safety plan and design, execute, and interpret results from in vitro and in vivo safety studies.
- Independently develop solutions and strategies within own expertise while using breadth of knowledge of other disciplines
- Scientifically assess and recommend vendors and outsource nonclinical studies to appropriate CROs
- Summarize safety studies for internal and external review and regulatory submissions
- Participate in early clinical candidate selection and asset characterization in support of clinical trials
- Assess innovative technologies in the field of toxicology and provide recommendations to advance Skyhawk’s toxicology screening strategy as appropriate
- DVM or PhD in Pharmacology, Toxicology, and/or a related discipline with at least 7 years of pharmaceutical Nonclinical Safety Assessment experience
- Knowledgeable with respect to current Regulatory Guidance (e.g., ICH) pertaining to the Nonclinical Safety Assessment of research and development drug candidates
- Knowledgeable with respect to GLP regulations and application thereof to ensure compliance of studies conducted to support the clinical development of drug candidates
- Broad expertise in designing, interpreting, and reporting Nonclinical Safety studies across relevant disciplines (e.g., safety pharmacology, genetic toxicology, general toxicology, etc.)
- Background in pre-mRNA splicing is a plus
- Strong interpersonal and organizational skills, as well as excellent oral and written communication skills
- Motivation, creativity, collaborative spirit, and team-oriented mindset focused on problem-solving in a goal-focused manner