What are the responsibilities and job description for the Vice President, Toxicology position at Orbital Therapeutics?
Position Summary :
The Vice President, Toxicology will be responsible for the non-clinical safety assessments supporting Orbital's development programs. The right candidate will be responsible and accountable for the design and execution of all safety studies, including off-target risk assessment and de-risking for discovery to early / late development programs. This candidate may also support platform workstreams. In collaboration with in vivo pharmacology group, they will coordinate interactions with CRO's to ensure delivery of study results and reports consistent with program timelines. Additionally, they will be accountable for the delivery of proper documents for regulatory filings.
Responsibilities :
- Serving as the function head, this role will lead the nonclinical safety strategy and execution for programs across discovery, nonclinical, and clinical stages.
- Oversee nonclinical safety related activities from discovery through regulatory filings and to commercialization for both our in-vivo development programs.
- Develop and oversee the execution of phase appropriate nonclinical safety strategies along with integrated project plans including milestones, timelines, and budgets.
- Provide strategic contribution as the subject matter expert for GLP, non-GLP safety assessments, off-target risk assessment, and safety pharmacology studies supporting development and platform programs.
- Provide toxicology support for regulatory submissions and interactions with health authorities, including the authoring of nonclinical safety sections of US and international regulatory applications and help resolve nonclinical safety queries.
- Drive and be accountable for delivery of high-quality safety reports to ensure clinical plans and regulatory filing submissions in multiple markets.
- Oversee in vivo pharmacology team to allow the execution of animal studies.
- Serve at the toxicology and / or nonclinical representative in cross-functional meetings both internally and externally.
Qualifications :
