Senior Director managing execution of clinical trial programs to advance gene therapy. Leading clinical operations, ensuring strategic execution, and mentoring clinical teams across multiple clinical programs.
Responsibilities
Manage overall execution of assigned clinical programs
Develop operational strategies and decisions to achieve clinical objectives
Oversee multiple clinical programs and Director-level employees
Ensure meeting all operational deliverables in timeline, cost, and quality
Maintain overview of status, issues, and communicate progress proactively
Co-lead a Clinical Sub Team and manage strategic topics
Interface with key internal and external stakeholders
Provide program leadership and expertise to trial teams
Mentor and coach Clinical Operations program team
Manage performance, talent, and resource for Trial Management staff
Ensure compliance with company and regulatory standards
Create a positive work environment
Requirements
B.S./B.A. degree in a related field
12+ years of relevant industry experience
At least 10 years focused on clinical trial management
Significant experience developing and implementing program-level plans
4+ years of experience leading clinical teams
Proven experience directing clinical program strategy
Previous experience in Neurology clinical trials
Extensive knowledge of FDA Regulations, GCP, and ICH guidelines
Strong computer skills including knowledge of Excel, Word, PowerPoint, and Outlook
Proficient written and verbal communication skills
Approx. 25% domestic and/or international travel may be required
Benefits
Secondment opportunity for unique experience
Encouragement of developmental discussions with managers
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