The Director of Clinical Operations oversees and directs the execution and oversight of clinical trials for the Company under the direction of the VP Clinical Science and Operations.  This individual will be responsible for the implementation of the clinical development plan. The role ensures that all clinical operation activities are executed in the most cost and time effective way, while assuring quality and GCP compliance. The Director of Clinical Operations will be accountable for timelines and budget, including best practice vendor and consultant management in achieving deliverables.   

Essential job functions and duties: 

• Responsible for implementation of the clinical development plan by managing the timeline, resources, and budget of clinical activities. This will include close supervision of Contract Research Organizations who will have responsibility for site interactions, site monitoring, data management, biostatistics, central laboratory support, pharmacovigilance and other critical clinical activities.
• Supports the clinical study team responsible for trial execution and is the primary point of contact for the assigned studies.
• Oversee and maintain the relationship with Contract Research Organizations and investigator sites.
• Authors and reviews project and study-related documents including: informed consent forms, monitoring plans, protocols and amendments, and other clinical documents as needed.
  
• Participates in the preparation of regulatory filings as needed.
• Oversee data quality including regular review of data metrics and listings.
• Leads, plans and executes clinical investigator meetings, study meetings and vendor meeting as needed.
• Interface effectively with other groups within the organization.
• Maintain a high level of professional expertise through familiarity with clinical literature.
  
• Develop and ensure compliance with SOPs and guidelines, FDA regulations and current ICH GCP guidelines
  

Minimum Requirements:

• Master’s degree preferred in a scientific/health care or public health field discipline, but not required. Professional certification (e.g., ACRP, SoCRA) a plus.
• At least 10 years of clinical research experience, including 3+ years as a CRA, CRC or PI.
• 3+ years of line management experience, including management, development and mentoring of assigned staff members.
• Excellent oral and written communication skills, attention to detail and ability to interact effectively with management and prioritize diverse projects for multiple disciplines.
• Excellent leadership, management, collaboration, communication and decision making skills.
• Effective process and project management skills.
• Independent, innovative, and creative thinker.
• Proven ability to positively impact company culture and demonstrate flexibility in fast paced environment.
• Extensive knowledge of ICH GCP, FDA Regulations and EU Clinical Trial Regulations; thorough knowledge of the drug development process.  ISO guidelines and device experience a plus.
• Strong partnering and collaboration skills.  Ability to work with different functional areas within the company and accomplish goals in a matrix environment.
• Must be willing to travel both domestic and international up to 30% (this includes some travel to corporate if incumbent is not based in Philadelphia)