The Opportunity:

The preclinical study manager is responsible for the operational activities associated with performing non-GLP and GLP toxicology studies from research to late phases of clinical development.  This includes being the primary operational contact and representative for RevMed to the contract research organization (CRO) performing each study.  He/she will be responsible for ensuring that each study’s scientific and corporate objectives are achieved, and are compliant with appropriate regulations, policies, standard operating procedures, and all relevant international regulatory guidelines/regulations.  Timely resolution of study-related issues, liaising with internal experts and/or consultants, and informing appropriate personnel are pivotal to being successful in this role. 

Required Skills, Experience and Education:

• Work with Contract Research Organizations (CROs), internal subject matter experts, and toxicologists to help design protocols that achieve the scientific objectives of each study.

• Monitor non-GLP and GLP toxicology studies through effectively managing day-to-day study-related activities and ensure study objectives are met against project goals.

• Assist toxicologists in the review of protocols, study reports, and protocol/report amendments to ensure high-quality results are generated by CROs.

• Coordinate study-related activities between RevMed personnel (toxicologists, Project Management, CMC, Bioanalytical, Regulatory, Finance, and Legal groups), and CROs to ensure program needs and timelines are met.

• Assist with data analysis and generate results tables and graphs as needed.

• Participate in regulatory submissions (e.g. preparation and/or review applicable nonclinical sections of IBs, NDAs, BLAs, etc.).

• Develop and maintain relationships with study directors, principal investigators, and external collaborators.

• Work with QA to facilitate CRO vendor selection/audit and due diligence activities.

• Negotiate contracts and manage internal approvals & execution process.

• Support the development and/or review of SOPs, policies, and guidelines.

• Other duties will be assigned as needed.

Preferred Skills:

• BS degree in science and minimum 5+ years of relevant experience in biotech, pharmaceutical and/or CRO industries.

• Knowledge of current GLP regulations, and ICH and FDA guidelines for drug development.

• Strong interpersonal skills and ability to work with cross-functional project teams and CROs.

• Effective communication, both verbally and in writing, and ability to facilitate open cross-functional collaboration.

• Ability to prioritize responsibilities and meet deadlines.

• Self-motivated and independent work ethics.

• Ability to travel to CRO partners as needed. 

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