Biotrial, a leading provider of high-quality pharmacology services, is currently recruiting a Clinical Pharmacology Unit Director for its U.S. headquarters in Newark, New Jersey. With over 25 years of experience in providing scientific and medical services in Early Clinical Development, Biotrial possesses one of the largest clinical capacities in Europe. The company's 60,000 sq. ft., 110-bed, state-of-the art Clinical Pharmacology Unit is in the heart of University Heights Science Park, attached to Rutgers/NJMS and the University Hospital.
The Clinical Pharmacology Unit Director supervises the overall operations, assumes full responsibility regarding activities conducted, and maintains and upholds the Unit to standards. The position works in close collaboration with the clinical project teams, medical and scientific affairs to help ensure efficient conduct of studies, and is responsible for providing accurate clinical data to the Sponsors.
This position is based and will work in the Newark, New Jersey Clinical Pharmacology facility.
Responsibilities: Duties and responsibilities will include, but not be limited to:
- Ensure smooth functioning of the CPU concerning the performance of services provided and the overall good functioning of the unit.
- Supervise the conduct of studies and ensure that they are high quality and delivered in a timely manner, according to Sponsor requirements. Additionally, ensure compliance with the applicable regulations and internal procedures.
- Ensure the operational management of all the staff and resources of the CPU including organization and management, qualified staff selection, etc.
- Provide support to the CPU principal investigator(s) and clinical research physician(s) to help ensure the quality of the studies conducted, participants' safety, quality of data collected, and compliance with medical and ethical standards, and Good Clinical Practices.
- Participate in sponsors' meetings and discussions.
- Participate in the feasibility assessment of proposed studies (on a technical and quantitative point of view as well as regarding the access to the target population).
- Ensure that the medical, clinical and recruiting staff coverage is sufficient to ensure the safety and proper conduct of studies.
- Accomplish efficient planning and forecasting for the CPU.
- Demonstrate sound fiscal responsibility in the development and management of the CPU budget.
- Develop and implement the most efficient work methods.
- Participate in the evaluation and selection of medical equipment and technology.
- Propose and participate in the development and implementation of new techniques and operating procedures.
- Proactively propose actions to ensure high quality of services provided.
- Work in compliance with applicable regulations, Good Clinical Practices and Biotrialinternal procedures.
- Supervise directly or indirectly the staff working in applicable units and assigned to Biotrial studies.
- Master's degree or higher in medical, healthcare or scientific discipline.
- A minimum of 10 years' experience in clinical research, preferably a CRO or research environment.
- A minimum of 5 years' leadership experience.
- Experience in conducting complex long-term projects and meeting strict timelines.
Skills and Abilities:
- Excellent communications skills with ability to interact with investigators, clinical research team, sponsors and members of the medical community, academic institutions, regulatory, governmental, and civic representatives.
- Thorough understanding of drug development and clinical research process.
- Excellent problem-solving skills.
- Leadership ability to develop staff, establish and maintain standards of performance.
- Superior interpersonal and communication skills.
- Good working knowledge of Microsoft Office Suite including Word and Excel.
Biotrial is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, genetics, disability, age, veteran status, or any other characteristic protected by law.