Associate Director, Nonclinical Safety Assessment
Scientific leaders in Nonclinical Safety Assessment provide scientific and strategic guidance for project teams ranging from lead candidate identification through clinical development and marketing. We are seeking a senior candidate who will be an independent scientific leader within the department, advise other department scientists, and guide development strategies on project teams.
Duties and Responsibilities
- Nonclinical safety development area leader: Strategic and scientific thought leader overseeing nonclinical safety for all programs in the development portfolio. This includes direct representation on teams as well as matrix management of other scientists in the group to appropriately represent aligned safety strategies for each team. Specific responsibilities include:
- Ensuring nonclinical safety representation on development teams, either as the primary nonclinical safety representative or through guidance of other nonclinical safety scientists
- Ensure appropriate design, initiation, and reporting of nonclinical safety (including GLP and investigative) studies conducted in house and at contract research organizations. Oversight will include direct preparation and/or guidance of day to day activities such as protocol reviews, regulatory submissions, and departmental data and strategy reviews at the SAFE-T forum as determined by the development area leader
- Serve as an internal subject matter expert, leading cross-functional strategic initiatives and extending scientific impact across the organization.
- Collaborate on research and development activities relevant to progressing programs and compounds in development in order to meet project, departmental and company objectives
- Ensure compliance with appropriate regulatory guidelines and standards
- Independently represent Theravance Biopharma at face-to-face and teleconference meetings with regulatory agencies and development partners
- Establish key safety criteria for progression into and through each stage of development
- Matrix management of all nonclinical safety scientists representing programs in development. Potential for direct management of nonclinical safety scientists
- PhD or equivalent in toxicology or related disciplines.
- DABT preferred
- 8+ years of experience in pharmaceutical/biotechnology drug development. Small molecule drug development experience required.
- A proven track record of complex problem solving, leadership, and significant contributions to project goals, including direct experience with US and/or international health authorities.
- Interdepartmental research interests and the ability to initiate, collaborate, and lead teams or address scientific issues.
- Well versed in GLP regulations and nonclinical testing guidelines
- Excellent written and verbal communication skills