Beschreibung

In this role, you will lead the planning and execution of nonclinical safety programs for drug candidates, ensuring effective communication between teams while analyzing safety data and authoring key regulatory documents.

Anforderungen

• •Advanced scientific degree (DVM; PhD in life sciences, Toxicology, Biology, Physiology)
• •Certification in Toxicology or Pharmacology and Toxicology
• •Minimum of 7 years' experience in pharmaceutical project environment
• •Broad knowledge in toxicology and safety pharmacology
• •Solid expertise in ADC’s or new modalities such as targeted protein degraders
• •Solid understanding of regulatory guidelines and submission documentation
• •Strong ability to work effectively in a team environment
• •Excellent communication skills in an interdisciplinary environment
• •Strong organizational skills and proficiency in spoken and written English

Aufgaben

• •Plan and oversee nonclinical safety programs
• •Develop and implement nonclinical safety strategies
• •Focus on new modalities and small and large molecules
• •Serve as the main interface between Global Program Teams and PSS
• •Ensure alignment and facilitate effective communication
• •Analyze toxicology and safety pharmacology data
• •Collaborate with cross-functional teams to implement safety strategies
• •Author nonclinical safety sections of regulatory documents
• •Provide expertise in due diligence reviews
• •Offer strategic recommendations for partnerships and in-licensing opportunities