To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #03591

About our client Our client is a rapidly growing biopharmaceutical company headquartered just outside Boston, MA that is focused on the development of therapeutics for diabetes. They have secured over $2M in funding over the past year. The company has an experienced management team, much proof of concept tests and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Director of Pharmacology Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Enable INDs and early clinical work for outsourced non-clinical safety studies of its lead formulation including GLP animal study contractor selection and supervision 2) Prepare requests for proposals, identify candidate contractors (toxicology, pharmacology, pharmacokinetics) and review responses 3) Oversee contractors including monitoring progress according to project timelines, milestones and budgets 4) Act as a scientific liaison and “Person-in-the-Lab” for critical study operations 5) Assist in defining pre-clinical safety plan based on regulatory and clinical requirements 6) Review, write and/or compile material for pre-clinical safety section of IND submission 7) Conduct due diligence audits of contractors and coordinate with regulatory consulting firm Requirements 1) Minimum 10+ years experience in biotechnology, pharmaceutical, or a related industry 2) Direct experience in new insulin product development including GLP safety pharmacology, pharmaco-kinetics/dynamics and regulatory submissions 3) Direct experience in selecting and overseeing GLP Contract Research Organizations (CROs) 4) Experience in preparing pre-clinical Safety section of IND submissions 5) In-depth knowledge of relevant quality systems including auditing, document development and review 6) Working knowledge of PK-related issues, including FDA terminology, calculation of key PK parameters from study data, etc.