Senior Manager, Therapy Development

Overview

Cook Advanced Technologies (Cook AT) offers an exciting start-up atmosphere, with the security of a large company, and is passionate about making a difference in improving the health and well-being of patients worldwide. Cook AT is currently accepting applications for a Senior Manager of Therapy Development. The person in this position provides strategic planning, non-clinical, and clinical support for early adoption of novel medical devices and the development of procedure workflow through direct physician interactions, medical staff education, and procedural consultation.

This person provides leadership and direction for planning and conducting non-clinical studies and prioritizes team efforts in support of established company objectives.

• Develop relationships with physicians, purchasing, and administration to understand adoption pathways within the healthcare ecosystem.
• Keep track of potential sites for interest in and development of program work.
• Support physician use of products for nonclinical and clinical evaluations.
• Understand clinical expectations and needs for Cook AT projects and provide periodic clinical experience to internal R&D teams.
• Support hands-on performance of non-clinical studies.
• Troubleshoot non-clinical testing issues, analyze, and interpret results.
• Assure that study deliverables and tasks are technically excellent and completed in a timely fashion.
• Document deliverables (plans, protocols, reports, design documents, education materials, etc.).
• Ensure compliance with regulations and applicable standards.
• Maintain and develop the technical capabilities necessary to support driving therapy development with management and technical teams.
• Mentor and develop team members.
• Practice continuous improvement by evolving both the quality management system and business processes.
• Conduct other corporate duties when required.

• BS degree or above in animal science, pharmaceutical science, or life sciences.
• Background in nonclinical and clinical research.
• Background in clinical product management and translating clinical feedback to technical teams.
• Minimum 15 years of relevant industry experience.
• Must be flexible to work various schedules and hours as well as provide comprehensive, after hours, and on-call coverage as needed.
• Innovative:
  Proven ability to generate novel concepts and create solutions to technical problems with an eye toward providing practical solutions in a timely manner.
• Task Oriented:
  Demonstrated knowledge and ability to plan, prioritize, coordinate and complete deliverables.
• Collaborative:
  Ability to effectively communicate and constructively collaborate with colleagues and be a team player.
• Professional:
  Ability to remain professional and positive in all personal interactions, and provide an example of good work ethics, a willingness to help, and personal discipline in achieving goals.
• Ability to handle multiple projects and changing priorities