Significantexperience in phase I/II Diabetes clinical Development is required
The Director ofClinical Research is responsible for the design, coordination and
supervision of clinical trials in the development of drug therapies.
Duties and Responsibilities:
- Directly manages one or more clinical program(s).
- Act as a therapeutic specialist/ clinical operations strategist /
operations leader in the development of drug therapies.
- Manage complex assignments in a variety of areas of
- Collaborate closely to ensure budgets, contracts, protocols, data
management, monitoring, study reports and timelines are appropriately delegated
and managed, as required.
- Maintain positive, strong working relationships with study sites,
vendors and study team.
- Demonstrate development, motivation and mentorship of study team,
- Support/conduct performance appraisals and assign responsibilities
as appropriate for study team.
- Ensure all necessary training is provided to study team to improve
their job performance and knowledge.
- Other duties as assigned.
Education & Knowledge Requirements:
- Advanced degree required, MD or PhD preferred in a medical or
scientific discipline, with a minimum of ten (10) years of progressively
responsible administrative experience in an academic or independent
pharmaceutical research environment.
- Ability and willingness to travel approx. 10%-20% of the time.
- Strong leadership, project management, teamwork and interpersonal
- Ten (10) or more years of clinical research experience and/or
basic science research, early phase clinical trial drug development preferred.
- Understands the drug development area (trained in GCP, HIPAA,
- Experience as a site monitor or auditor on clinical trials.
- Worked in development and review of protocols, inform consent,
data management plan (eCRF, review and cleaning of data, query management),
statistical analysis plan and clinical study reports.
- Study contract familiarity, budget negotiations.
- Familiar with ethics submissions and regulatory filings.
- Works well in fast paced environment.
- Excellent MS Office skills.
- Study document review (protocol, Investigator Brochure, Informed
consent, case report forms, source documentation, tables, figures and
- Create, critique, and implement Standard Operating Procedures.
- Excellent communications and presentation skills