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Job #02904
About our client
Our client is a global specialty pharma and medical device company located just outside of Chicago, IL. They focus on the design, development and manufacturing of solutions to improve the safety, delivery and effectiveness of patient healthcare.
Position
Location
Director of Pre-Clinical Development/Toxicology
Lake Forest, Illinois
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Provide expertise and consultation for multiple drug as well as drug device candidates through all phases of preclinical and clinical development
2) Interact with appropriate Specialty Products, Regulatory, Clinical and Quality personnel
3) Recommend and play an active role in the planning of safety studies
4) Perform contract work (as required) from other functions (such as pathology, kinetics, metabolism and drug analysis) to ensure optimal compound evaluation
5) Anticipate, recognize and resolve scientific as well as technical problems that are encountered during various phases of drug/device evaluation
6) Monitor timelines and cost
7) Conduct broad literature reviews
8) Maintain an understanding and make conclusions, and/or critically evaluate data from multiple disciplines
9) Integrate data across disciplines to draw new or extended conclusions
10) Define alternative scenarios for aspects/parts of larger problems
11) Provide complex communications under tight deadlines
12) Communicate relevant facts clearly and concisely
13) Serve as facilitator to ensure that appropriate individuals are involved in key decision-making and interpretive efforts
14) Develop and/or participate in presentations in an internal and external venue, to include US as well as international regulatory agencies
15) Serve as a central person for direction of company product development and disposition
16) Act as the contact person for preclinical safety when in-licensing compounds are to be evaluated
17) Supervise and manage subordinates (up to 5)
18) Oversee staffing, workflow scheduling and staff development
Requirements
1) Ph. D./advanced degree in a relevant scientific field directly applicable to pre-clinical safety
2) Board certification in toxicology preferred
3) 7 – 10 years of relevant experience in managing direct product development teams and all related activities (science, technology, quality, regulatory and compliance requirements)
4) Minimum15 years of experience in the drug development and drug discovery industry
5) Ability to empower and delegate effectively
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