Associate Director, Toxicology (Open to Remote, Lower Levels)
Position Summary:
Our client is a biopharmaceutical company determined to discover, develop, and deliver innovative treatments that provide hope to underserved patient communities. The company has one FDA-approved therapy for sickle cell disease and multiple investigational therapies in development for the disease.
We are seeking for a toxicologist to interact with research and development teams to design critical pathways for nominating compounds as development candidates, design and conduct safety evaluation of development candidates to support clinical trials and registration, and to prepare nonclinical sections of regulatory submissions. This position is an individual contributor role and reports to the Head of Toxicology.
Essential Duties and Responsibilities:
- Serves as Project Toxicologist on project teams in Research and Development
- Collaborates with Research to develop critical pathways to select development candidates
- Designs and manages studies for regulatory submissions that support clinical trials and product registration
- Interacts with regulatory agencies on toxicity issues related to their projects
- Maintains awareness of current and emerging standard practices and guidelines in the field
Qualifications:
- Academic training in toxicology, pathology or related discipline, preferably with advanced degree (Ph.D., D.V.M.) and board certification (DABT, DACVP)
- At least 10 years of relevant experience in toxicology with a minimum of 7 years in pharmaceutical drug development; the level will be commensurate with experience
- Development experience with small molecules (required)
- Ability to work with interdisciplinary teams
- Excellent communication skills
- Excellent organizational and time management skills
- Experience with managing studies conducted at CROs