Description:
- As the Translational Medicine and Preclinical Research Manager for a 3-4 month assignment, you will play a pivotal role in advancing our clients’ development pipeline by overseeing the translational medicine and preclinical research activities. This includes identifying and developing appropriate preclinical animal models, managing relationships with Contract Research Organizations (CROs), and ensuring the timely delivery of preclinical study results.
Job Responsibilities:
- Identify and develop preclinical animal models for pipeline products.
- Engage with CROs, establish and maintain Master Service Agreements (MSA), develop and review Statements of Work (SOW), and oversee the entire lifecycle of contracted animal studies.
- Collaborate with Project Teams to ensure timely delivery of study results and plan for future studies.
- Actively participate in cross-functional meetings, providing input on project issues and clinical designs.
- Utilize project management framework to plan, monitor, and control protocol progress.
- Participate in diligence activities for new opportunities and support the preparation of regulatory documents for IND and NDA submissions.
- Manage budget planning and reconciliation for all nonclinical activities.
Job Qualifications:
- Minimum Bachelor’s Degree in a science field; PhD in a related field preferred.
- 5+ years of relevant industry experience, with CRO management experience.
- Experience in translational science with a focus on preclinical pharmacology, safety, and PK/PD preferred.
- Knowledgeable in experimental designs, statistical tools, and software applications.
- Proficient in evaluating and ensuring appropriateness of bioanalytical methods.
- Scientific writing experience (protocols, SOPs, reports, etc.).
- Strong data analysis, problem-solving, and persuasive communication skills.
- Excellent understanding of GLPs and ability to work independently in a matrix environment.
- Self-motivated with the ability to work with limited supervision.
- Able to articulate scientific principles and apply them to early phase clinical study design.
PLUS:
- Animal health lab, working knowledge of Office Suite, Excel, PowerPoint etc., is used a lot along with Teams and SharePoint.
NJ: Pre Clinical Manager (234111)
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