CAREERS
OPEN POSITIONS
Position: Non Clinical Study Director
Date Posted: March, 2010
Job Code: 1353
Reports to: LC
Position Requirements:
The Director of Non-Clinical Research will be responsible for maintaining a comprehensive program for testing a monoclonal antibody therapeutic product for non- clinical safety and for interfacing directly with the company’s Regulatory and Clinical departments to formulate a strategy for FDA licensure of products using the FDA’s “Animal Rule”. Position will also be responsible for the following:
- Provide technical expertise in biological drug development
- Provide input to improve moderately complex aspects of biologics development
- Serve as a technical resource to the company by providing input on product innovation, product development, and product enhancements
- Build and facilitate relationships to enhance knowledge base
Qualifications:
- Masters degree in biology, related field or equivalent combination of education and experience; doctorate (PhD or DVM) preferred
- Eight or more years of experience in biotechnology/drug development field
- Significant experience in operating in a GLP environment
- Candidate must demonstrate strong pre- and post-doctoral training in non-clinical efficacy and safety models, with preference given to candidates with experience in using whole-animal models of efficacy testing against pathogenic diseases
- Must be able to work both independently as well as a member of a matrixed team
- Must demonstrate flexibility and an ability to manage strategy within a matrixed organization, clearly identifying and distinguishing “need to know” scientific objectives
- Must demonstrate good organization skills to balance and prioritize work
- Must demonstrate excellence in both written and oral communication, and good interpersonal skills to interact with customers and team members
- Must demonstrate good analytical and problem solving skills
Responsibilities:
- Review non-clinical path to licensure and add/modify studies when deficiencies are identified or development of plan changes
- Liaison between Elusys regulatory/FDA and study director
- Respond to stakeholder comments from funding agencies and modify studies as needed
- Long-term scheduling of studies for CRO contracts, design of studies, and site visits to CROs
- Interaction with team, project manager, and CRO to make sure studies stay on time and within budget
- Interaction with biostatisticians to analyze data, obtain graphic output that serves communication purposes
- Technical review of GLP final reports
- Assemble presentations for government sponsors, scientific advisors, conferences
If you want to work in a dynamic, challenging yet entrepreneurial environment, we invite you to review these exciting career opportunities.
Candidates please EMAIL your resume, with a cover letter referencing the job you are applying for, to info@elusys.com or fax it to 973.808.0322 attention Human Resources or mail it to Human Resource Department, Elusys Therapeutics, Inc., 25 Riverside Drive, Box 102, Pine Brook, NJ 07058.