Head of Preclinical Development INTRODUCTION:
The ideal candidate is a Ph.D. level scientist who has extensive experience in the drug development process leading to compound selection and promotion including DMPK studies and toxicity testing AND would like to be part of a dynamic biopharmaceutical company engaged in the discovery, development and commercialization of novel products in the field of cancer care. MISSION STATEMENT:
This position will oversee the following aspects related to small molecule drug development: Pharmacology (in vivo and in vitro), drug metabolism, pharmacokinetics, and toxicology (GLP and non-GLP). The qualified candidate should have demonstrated expertise/accomplishments in one or more of the above areas. RESPONSIBILITIES:
Create and implement strategic and operational preclinical development plans related to: Pharmacokinetics, Drug Metabolism, Pharmacology and Toxicology with Program Leadership for successful and efficient product development. • Assume the scientific, administrative, and technical responsibilities of the Preclinical Development Department
• Build and maintain close collaboration with other departments in support of early drug discovery /development and lead optimization
• Identify and develop alternative strategies to manage risk and maximize the value of preclinical development efforts
• Provide ongoing monitoring and facilitation on all critical path timelines, and issues as they related to preclinical development
• Use appropriate project management tools in planning and coordination of projects to establish aggressive but rational timelines and resources across all projects
• Recruit, train, and retain talented staff members in Department QUALIFICATIONS:
• A minimum of 10 years of relevant experience in small molecule drug discovery and development.
• Demonstrated success in leading and participating in cross-functional teams.
• Superior written and verbal communication skills.
• Ability to motivate, coach, and develop scientists in Department.
• Experience in placement and management of outsourced in vitro and in vivo studies.
• Proven ability to work in a team environment & the capability to supervise highly skilled scientific personnel.
• Demonstrated scientific expertise in one or more of following: toxicology (board certification a plus); PK and/or PD modeling; ADME/in vitro metabolism; assay development.
• IND authoring experience required.
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