Compensation: $ 100,000 - $ 150,000 Years of Experience: 5-10 Education: Masters
Order & Position Details
I am seeking a highly motivated individual with a significant knowledge of drug development, pre-clinical study monitoring experience and a management background. This individual will represent the Pre-Trial Group in cross functional Project Teams and supervise direct reports. This highly qualified Manager will serve as the single point of contact for all study-related requirements (GLP and non-GLP) that have been contracted to external Contract Research Organizations.
Partial Responsibilities
· Develop and streamline processes to maximize efficiency in the execution of non-clinical studies.
· In partnership with investigators and CROs: design, implement and interpret various types of complex non-clinical studies that support all phases of drug development.
· Assist senior personnel in identifying and defining critical study and project tasks.
· Make sound and timely decisions based on study needs, foresee and circumvent problems, develop and refine procedures to advance therapeutic candidates.
· Collaborate with internal and external contacts and resolve study-related issues as they arise.
· Identify and implement process improvements with respect to study execution and documentation in conjunction with Quality Assurance Unit.
· Develop and review SOPs. -Maintain communication with CROs to assure studies are conducted in compliance with the protocol, GLP, SOPs, and overall non-clinical objectives.
· Assist in preparation of reports for regulatory submission.
Requirements:
· BS or BA in Toxicology/Pharmacology/Immunology/PK/Biological Sciences or related discipline required (MS or Ph.D. preferred).
· Minimum of 8 years management experience with in vivo studies or GLP studies.
· 3+ years of experience managing direct
· Travel required up to 25%.
Important: (HOW TO APPLY)
Interested Applicants may do the following;
1. Explain why you are the best candidate of the job position? Attached the explanation in your coversheet.