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
  responsibilities, simultaneously.
• 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,
  as required.
• 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.

Infrequent Functions:

• Ability and willingness to travel approx. 10%-20% of the time.
• Qualifications:
• Strong leadership, project management, teamwork and interpersonal
  skills.
• 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,
  ICH).
• 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
  listings).
• Create, critique, and implement Standard Operating Procedures.
• Excellent communications and presentation skills