We are working with a prominent Specialty Hospital located in Manhattan, NY. They are seeking a Product Development Manager for a dynamic team with the Regulatory Oversight and Product Development Unit. The Product Development Manager is the institutional resource to investigators, core facilities, clinicians and licensing managers for scientific and strategic product development through the IND or IDE process.
Provide short and long-term strategic planning and standard methodologies advisory for nonclinical studies, CMC and GMP, clinical and regulatory landmarks.
Provide consultancy and advisory services to help investigators develop their compound(s) in an efficient and timely fashion following standard methodologies.
Provide directional and technical leadership to drug and device development projects: CMC, Pharmacology and Toxicology, Clinical Pharmacology, Regulatory Programs.
Own the drug development team in writing technical regulatory dossiers for the FDA or foreign regulatory bodies on behalf of the institution.
Ensure nonclinical studies are conducted at the right time of development and will serve the global goals of the sponsor.
Collaborate with preclinical laboratories (toxicology, ADME, pharmacology, and CMC) and provides scientific, developmental and clinical expertise to the team.
Work with investigators and core labs to define product specifications and testing for CMC.
Author official IND Applications (CMC/Pharm Tox) to FDA/EMEA.
Master's degree in life sciences, biochemistry, biotechnology or a related discipline.
Ph.D. in Biomedical Sciences, Pharmacy or a related Life Science preferred.
7-10 years of experience in drug development or related industry experience within the bio manufacturing, biotechnology, biopharmaceutical industry.
Knowledge and understanding of GLP, GMP, QC/QA and related industry standards for biologics manufacturing is essential.
Excellent oral and written communication skills.
Strong collaboration skills.
Ability to analyze and provide constructive feedback on scientific data
Ability to lead complex projects with visionary milestones in high pressure circumstances
Excellent computer and software skills (database management, spreadsheet, word processing and graphics applications
Deep understanding of drug development and/or experience in more than one functional area such as non-clinical development, translational development, regulatory or clinical R&D
Ability to motivate and develop individual team members and overall team performance.
Ability to effectively handle conflicts and negotiations while providing impact and influence.
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