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 Operations & Compliance. This individual will be responsible for tactical implementation of the clinical development plan. The selected incumbent 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. Further he/she will develop and coach a team of highly effective clinical operations professionals.
Clinical trial execution and oversight
Oversee tactical implementation of the clinical development plan by managing the timeline, resources, budget, and staff of clinical activities
Oversee and maintain the relationship with Contract Research Organizations and investigative sites.
Write clinical operation sections of regulatory documents including protocols, Investigator Brochures, IND annual reports, and others as needed or requested
Develop study feasibility and cost estimates for outsourced work
Build trial operation infrastructure
Partner with supervisor to develop staff, structure department, and create a highly desired work environment for attracting and retaining highly qualified clinical operations professionals
Develop and ensure compliance with SOPs and guidelines, FDA regulations and current ICH GCP guidelines
Evaluate and analyze tools and processes to support outsourcing efforts
Work with Clinical Operations team to identify and develop efficient systems for enhancing department efficiency
Develop and direct process for prequalification of vendors; Request for Proposal (RFP) processes and policies
Interface effectively with other groups within the organization
Maintain a high level of professional expertise through familiarity with clinical literature
Work with senior management to develop and to achieve corporate goals and work with clinical operations staff to achieve the established corporate goals within the expected time frames
Participate on project teams and study teams as needed or requested
Act as key resource to provide financial information related to clinical development. Interface with finance group to manage trials costs
Collaborate with legal department to develop improvements to document templates, standard processes and tools.
Travel: Up to 20%, primarily domestic
Qualifications & Requirements:
Required education: Masters degree in life science/healthcare
Area(s) of expertise desired: Biology, Immunology, Bioengineering, Cell or Molecular Biology. Experience with vaccines highly preferred.
Medical device experience required.
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.
At least 12 years of clinical research experience, which must include at least 5 years at a CRO.
Minimum of 5 years staff management experience
Thorough knowledge of all applicable regulations, including FDA/EMA, ICH, GCP and ISO guidelines. Medical device experience a plus. Regulatory affairs experience a plus.