Duties: The Director of Clinical Operations is responsible to ensure that the translation of gene therapy research is achieved by managing its Federal Drug Administration (FDA) clinical trials. As a physician, the Director will be engaged in the every aspect of patient care as defined in the study protocol(s) leading both the Medical Monitoring and Operations teams prior and subsequent to trail execution. Additionally, the Director will manage/supervise the clinical and administrative personnel, including Associate Directors, assuring that each clinical trial meets patient care expectations and that they are conducted in accordance with the specific clinical protocol(s) as approved by the Sponsor, study team and in accordance with all regulatory organizations. The Director will engage and manage the performance of each Contract Research Organizations (CROs), and ensure that Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), regulatory guidelines, and all best practices are followed rigorously. The Director will work among senior leadership including the Study Sponsor, GTP Director, the CRO & GTP Project Managers, Associate Director(s) and Clinical Operations staff, managing all clinical and operational aspects of each trial, allocating resources as needed. In addition to clinical trial management, the Director is responsible for the financial management of each trial, establishing the budget required to meet trial goals and for the allocation of financial resources to assure that the clinical trial(s) is executed fully. The Director is also responsible for the development and implementation of innovative process ideas that impact clinical trials and/or clinical program management and to implement clinical operations quality systems, document management, and quality control processes. At all times the Director is expected to remains actively engaged in organizational goals especially those directly related to GTP research. Central to the position is meeting all reporting requirements of all external review organizations, most notably the Food and Drug Administration (FDA).
Qualifications: Combination of educational and work experience demonstrating competencies to perform the duties and responsibilities of the position; Doctor of Medicine degree required; Minimum of 7 to 10 years experience in clinical care/clinical trials; thorough understanding of clinical processes (eg. differential diagnosis) data management, biostatistics, and medical writing; strong, proven supervisory and management experience; Strong knowledge in GCP and ICH and the application to the conduct of clinical trials; Ability to clearly develop action plans to ensure delivery on company strategy and goals as well as clinical development plans; Must be a demonstrated self-starter and team player with strong interpersonal skills; Excellent written and verbal skills required; Must display strong analytical and problem solving skills; Attention of detail required, and; the position requires the flexibility to travel.
Reference Number: 40-21070
Salary Grade: 032
Employment Type: Exempt
Org: DM-Gene Therapy Program
Job Family: B-Executive/Managerial Administration