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Director of In Vivo Studies

Director of In Vivo Studies-The Director of In Vivo Studies will serve as the sponsor manager in the direction and execution of all in vivo studies, clinical and non-clinical in compliance with GLP and/or GCP guidance and FDA regulations. The Director will write and/review all study outlines and protocols and review and route final reports for approval. The Director will manage, plan and coordinate the timing and execution of in vivo studies in alignment with sponsor strategic goals. The Director will facilitate merger of standard study protocols into or in assists CROs for alignment with CVM format to submit to CVM. The Director will identify, facilitate, quote and finalize selection of CROs for in vivo study conduct and will assist sponsor and CRO in appropriate study strategy as well as participant selection and enrollment criteria and caveats. The Director will review and coordinate approval of any study protocol amendments and/or deviations. The Director will assess and approve CRO data collection processes and systems and will review, interpret, integrate and present data on assigned studies. The Director will audit CROs and attend dosing sessions where appropriate to ensure study practices are compliant with FDA GLP and/or GCPs. The Director may coordinate employment of study monitors as needed. The director will monitor study timelines and milestones to ensure on-time delivery of data and will prepare and review study reports and data for FDA submissions according to relevant guidelines. The Director will assist in CRO site visits and audits of relevant contract facilities and vendors as necessary, will maintain tracking and inventory of study outlines, protocols, amendments and data records and will manage lifecycle of and maintain up to date inventory status of all study samples. The Director will participate in educational opportunities to increase knowledge about clinical trials, regulations and guidance’s and will perform ongoing research to remain current regarding specific disease/conditions that may influence progress or outcome of in vivo studies.

Qualifications include 2-5 years minimum pharmaceutical industry experience, 2-3 years minimum non-clinical study monitoring experience, 2-5 years FDA regulatory experience, knowledge and experience with FDA regulations and requirements (GLP and/or GCP), 2 years of technical writing and editing, 1-2 years clinical/non-clinical laboratory experience and 1-2 years of project management experience. A BA/BS in technical field or scientific discipline (Veterinary Science, Biology, Bio-chemistry), experience with Microsoft Office Suite programs, especially, Word, Excel, Project Experience with FDA compliant study protocol design, good written and verbal communication skills, self-motivated and self-starting, strong interpersonal and organization skills.

Preferred qualifications include 5+ years of animal pharmaceutical industry experience, 5+ years of clinical and/or non-clinical study monitoring experience, strong working experience with FDA regulations and requirements with the ability to integrate into projects, solid knowledge of GLP study requirements, 3-5 years non-clinical laboratory experience, 3-5 years in technical writing and editing and 3-5 years of project management experience. Advanced degree (MS, PhD in technical field or scientific discipline such as Veterinary Science, Biology, Bio-Chemistry or DVM), skilled within Microsoft Office Suite programs, especially Word, Excel, Project, Experience with SharePoint or other Document/information management software, project management software experience, solid understanding of statistical and raw data analysis software, Proficient with FDA compliant study protocol design, excellent written ad verbal communication skills, keen organizational and troubleshooting skills, highly adaptable.

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