Director Drug Safety

vor 1 Woche


Basel, Basel-Stadt, Schweiz Batterman Consulting Basel AG Vollzeit

Our client, Skyhawk

is a cutting-edge biotech company that is developing innovative small molecules to target RNA processing of disease factors, even those that were once deemed impossible to treat. Their main aim is to create treatments for some of the toughest diseases in the world. They have established a sophisticated, in-house platform that speeds up the discovery and development of small molecule drugs targeting RNA by leveraging their expertise in RNA and drug development and collaborating with major pharmaceutical firms. Their primary product in progress, SKY-0515, is a modulator targeting HTT RNA splicing, currently undergoing testing in a Phase 1 trial for Huntington's disease. Location: Basel / hybrid

Responsibilities
  • Serve as the Project Safety Representative for early Discovery to Phase 1 projects, which involves critical evaluation, risk assessment, and communication (including creating regulatory documents for First-In-Human studies) related to nonclinical safety data, and contributing to the overall program strategy
  • Design, oversee, and monitor outsourced nonclinical safety studies for assigned projects, including interactions with key CRO partners
  • Assess target safety and contribute to toxicology research efforts
  • Evaluate and suggest vendors and outsource nonclinical studies to suitable CROs
  • Compile safety study summaries for internal and external reviews and regulatory submissions
  • Participate in the selection of early clinical candidates and asset characterization to support clinical trials
  • Evaluate cutting-edge technologies in the toxicology field and provide recommendations to enhance Skyhawk's toxicology screening strategy
Qualifications
  • DVM or PhD in Pharmacology, Toxicology, or a related field
  • Minimum 7 years of experience in pharmaceutical Nonclinical Safety Assessment, with project representation in early compound development
  • Board certification in the respective field (e.g., DABT or DACVP) is preferred but not mandatory
  • Familiarity with current Regulatory Guidance (e.g., ICH) on Nonclinical Safety Assessment of research and development drug candidates
  • Extensive expertise in designing, interpreting, and reporting Nonclinical Safety studies across relevant areas (e.g., safety pharmacology, genetic toxicology, general toxicology, etc.)
  • Background in pre-mRNA splicing is advantageous
  • Excellent interpersonal and organizational skills, along with strong oral and written communication abilities
  • Driven by motivation, creativity, collaboration, and problem-solving within a goal-oriented team environment

If you are intrigued by this rewarding opportunity, please submit your application online to Mr. Kelaja Wick. More exciting job openings and application details can be found on our website. We are excited to potentially meet you soon. Confidentiality is paramount to us.

Batterman Consulting is a pioneering Swiss company specializing in Executive and Professional Search within the Life Science, Industrial, Real Estate, and Construction Management sectors.



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