Director Toxicology

July 1, 2024

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Director Toxicology

Permanent

Ref: BH-2036

Director Toxicology

Job details

Permanent

Ref: BH-2036

Website headcount AG

Director Toxicology (Remote)

The Director Toxicology will join the Early Development group and be part of the Safety Pharmacology & Toxicology team to support drug development. This role focuses on ensuring the non-clinical safety assessment of new chemical entities (NCEs) from early discovery phases through to product registration.

Key Responsibilities

Study Design and Oversight: Design in vitro and in vivo non-clinical safety studies, select CROs, and monitor study progress to ensure alignment with project goals and regulatory requirements.
Data Interpretation and Reporting: Interpret study results and communicate findings effectively to managers and multidisciplinary project teams.
Regulatory Compliance: Ensure studies adhere to ICH and OECD guidelines, and author/review non-clinical safety sections of regulatory documents
Budget Management: Conduct budgeting activities and regular forecasts to ensure financial resources are appropriately allocated and managed.

Impact on Drug Development:

Safety Assurance: Conduct thorough non-clinical safety assessments to ensure that only safe and effective drug candidates proceed to clinical trials, reducing the risk of late-stage failures and potential harm to patients.
Regulatory Success: Provide high-quality safety data and well-documented regulatory submissions to increase the likelihood of successful regulatory approvals, thereby accelerating the time-to-market for new drugs.
Operational Efficiency: Manage CROs effectively and rigorously monitor studies to maintain high standards and operational efficiency, ensuring reliable study outcomes and fostering strong partnerships with external collaborators.
Strategic Contributions: Interpret and communicate study results to aid in strategic decision-making, providing critical insights into the safety profiles of drug candidates and supporting informed decisions on project continuations or terminations.

Profile and Expertise Required:

  1. Educational Background: PhD in life sciences (toxicology, veterinary, biochemistry, pharmacology, molecular biology, or equivalent) is essential.
  2. Industry Experience: Minimum of 7 years in the pharmaceutical industry, specifically in conducting non-clinical safety and toxicology studies with small molecules.
  3. Technical Knowledge: Deep understanding of toxicology, risk assessment, GLP regulations, and regulatory toxicology guidelines (OECD and ICH).
  4. Professional Credentials: European Registered Toxicologist and/or DABT certification is advantageous.
  5. Collaboration Skills: Proven experience in establishing and managing relationships with CROs and other external partners, crucial for ensuring smooth project execution and adherence to timelines.

This role, which reports into the Head of Toxicology, plays a pivotal role in advancing drug candidates from research to market registration by ensuring their safety and compliance with regulatory standards. This position significantly impacts the success of individual projects and contributes to the overall mission of developing safe and effective therapies for patients.

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