Senior Director Drug Safety & Toxicology - Batterman Consulting
Serve as Project Safety Representative on early Discovery through Phase 1 projects, including 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
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
Your profile
DVM or PhD in Pharmacology, Toxicology, and/or a related discipline
At least 7 years of pharmaceutical Nonclinical Safety Assessment experience, including project representation through early compound development
Board certification in the respective field (e.g., DABT or DACVP) preferred but not required
Knowledgeable with respect to current Regulatory Guidance (e.g., ICH) pertaining to the Nonclinical Safety Assessment of research and development 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
Our client
Skyhawk is a clinical-stage biotechnology company developing novel small molecules designed to modulate RNA processing of disease targets, including those traditionally thought to be “undruggable,” and yield therapies for some of the world’s most intractable diseases. They have built a sophisticated, integrated proprietary platform that efficiently accelerates the discovery and development of small molecule RNA targeting drugs by leveraging our RNA and drug development expertise and collaborations with large pharmaceutical companies. Their lead product candidate, SKY-0515, is an HTT-targeted RNA-splicing modulator currently being evaluated in a Phase 1 trial for Huntington’s disease. Location: Basel / hybrid
