Director Biology - Delaware, United States - Unio Search

Description

Unio Search has exclusively partnered with a global Clinical Research Organisation (CRO), which is expanding its R&D department.

They support global pharmaceutical, biotechnology and medical device companies with their drug development efforts providing a range of preclinical, lab and clinical services.

Overview of the role:

This is an opening for a Director of Biotransformation to join the senior leadership team within the global R&D department.

You'd be responsible for providing expert drug metabolism support including managing, organizing and overseeing all aspects of the laboratory, readily identifying needs (procedures, equipment, supplies, etc.), taking action to meet these needs for optimal performance of lab and/or safety, and managing the profit margin for their group

Key Responisbilities:

• Manage scheduling, ensuring data generation meets quality standards and deadlines.
• Oversee biotransformation studies, including discussions with clients, radiolabeling, sample extraction, and result interpretation.
• Supervise scientific staff, including hiring, training, and performance reviews.
• Coordinate study activities with other teams and optimize procedures for efficiency.
• Review and approve study reports, audit reports, and investigations.
• Assist with budget preparation and monitoring.
• Contribute to strategic planning and departmental growth.
• Evaluate new technologies for research improvement.
• Mentor and train team members.
• Facilitate client technical visits and participate in audits.
• Review and prepare proposals.
• Make decisions on project viability.
• Deliver presentations on current and potential projects.

Non-negotiable Experience Required:

• Experience with FDA guidance and Industry practice.
• Demonstrated supervisory and managerial ability.
• Excellent oral and written communication skills, both external (client communications) and internal.
• Demonstrated competency in scientific publications and presentations.
• Demonstrated project management skills.
• Experience with in vivo preclinical ADME studies and understanding of clearance route and mechanism, and the role of metabolism/catabolism is essential.\
• Proven experience in the design and conduct of pre-clinical and non-clinical metabolite profiling and characterization studies including structural elucidation, interpretation of mass spectra and determination of metabolic pathways.
• Proven experience in design and conduct of in vivo pharmacokinetic and drug metabolism studies in animals.
• Experience interacting with North American and international regulatory agencies.
• Demonstrated experience supporting biotransformation/bioanalysis of new modalities (i.e. ADC's, peptides, RNA, siRNA)

Education Required:

• Doctorate-level degree with ≥ 12 years of related experience

OR

• Masters level degree with ≥ 14 years related experience
• Preferred educational background in Organic, Medicinal or Analytical Chemistry