Director Clinical Operations

About:

Clora's client is a clinical-stage biotech focusing on cell therapies for autoimmune diseases and inflammatory disorders. They are looking for a Clinical Operations Lead with proven experience with early and late stage programs to manage day-to-day study start-up, maintenance, and close-out activities for the organization's Idiopathic Inflammatory Myopathy PhII/III study and the upcoming Rheumatoid Arthritis PhII study as well as additional clinical trials.

This role will be a senior level individual contributor role with CRO oversight responsibilities.

Candidates should be based out of central Florida/Gainesville, FL region or be willing to relocate.

Benefits: Competitive benefits package & variable compensation component

Relocation assistance (if outside central FL): Available

Visa Sponsorship: Candidates must have full work authorization to work in the US without employer visa sponsorship.

Responsibilities:

• Management and oversight of study start-up activities for our active PhII/III study and upcoming PhII trial as well as additional clinical trials.
• Collaborate closely with the Chief Medical Officer and Clinical Development team to develop and execute the clinical operations strategy to support FDA submissions
• Manage vendor selection, sites, investigators, budget negotiation and oversight
• Develop and maintain clinical timelines, budgets, and critical study documents and management plans
• Support and own cross-functional activities throughout study start-up as needed including patient recruitment

Ideal Candidate:

• 8 years of Clinical Operations and Clinical Project Management experience. Ideally, 2-3 years in a Clinical Operations leadership capacity for a sponsor organization
• Early and late-stage trials for Cell Therapy and/or Autoimmune, Inflammatory Disorders is strongly preferred
• Strong understanding of the regulatory environment, procedures, processes, SOPs, etc.
• Experience in start-up environment with lean teams