Associate Director, Pre-Clinical Safety and Efficacy
Design, plan, and implement safety/toxicology and efficacy studies required for IND submissions and licensure of products. Duties include identifying CROs, establishing contractor, and working in conjunction with study directors at CROs to prepare and implement protocols necessary for GLP safety and efficacy studies. Duties also include acting as a liaison between departments to ensure that materials needed for studies are available when required and that materials required for use in the studies are shipped to and from CRO or academic institutions in an expeditious manner as required to meet deadlines for regulatory submissions.
Also responsible for representing PS&E department on project teams. Responsibilities include the management of animal facility for internal studies. Duties also include monitoring of internal and external nonclinical studies, compilation and appropriate presentation of data (including statistical analysis as required) and ensuring that internal and external reports are written accurately and submitted in a timely manner. Some travel will be required. May be required to participate in IACUC.
Requirements:
- At least 5-10 years previous experience with safety and efficacy studies in pharmaceutical or biotech industries.
- Previous experience working with variety of animal models is required.
- Accuracy and attention to detail and excellent oral and written communication skills are required.
- Project management and experience in a team environment is also a necessity.
Education and experience:
PhD in toxicology, pharmacology, or a related field with over 5 years of relevant experience required.
(Job Code: 200714R)