The Director of Clinical Research Operations, is responsible for the development and implementation of the clinical trial strategy and directing all clinical study activities including planning, operations and reporting. Ensures efficient execution of trials within established budgets and timelines, and compliance with appropriate regulations, including FDA, privacy, and ICH requirements. Responsible for on-label post-market descriptive and investigational studies, as well as pilot and pivotal studies supporting regulatory registration. Coordinates the efforts of internal and external resources to ensure sound study design, careful site selection, rapid subject recruitment, trial plan optimization and execution of trials with a focus on quality, innovation and efficiency. Studies will be conducted in-house by the clinical research staff and with support from external vendors including contract research organizations.
Ensures that the clinical projects produce successful, relevant results for the Company’s business development strategy and drive the development of strong Intellectual Property.
Manage clinical departmental functions, systems, documentation, and procedures for the successful conduct and audit of clinical studies.
Interact with Regulatory Affairs and FDA or other regulatory authorities regarding clinical research in support of product registration.
Collaborate with a multidisciplinary team in the development, creation and execution of study protocols that achieve the Company’s strategic goals, including timelines and budget development.
Establishes and approves scientific methods for design and implementation of clinical protocols and final reports.
Ensures clinical data meets all necessary regulatory standards.
Delivers reports and presentations on the progress and the findings of the clinical research programs.
Translate findings, both existing and new, from research and pre-clinical studies into clinical development opportunities and provide input into the future design of studies. Lead the identification, evaluation, and selection of vendors as needed to support clinical trials.
Manage a clinical database that tracks treatment and outcomes of patients treated with the Company’s products in both clinical trials and commercial usage, supporting the needs of marketing, business development, life sciences and sales.
Develops and maintains relationships with key opinion leaders (KOLs) and clinical scientists to support Regenesis development activities on a global basis
Oversees activities leading to GCP audits and regulatory inspections related to clinical trial conduct
Ensures adherence of the clinical team to ICH, GCP, company SOPs and other applicable regulations.
Review promotional material for compliance with agency regulations.
Lead and mentor the clinical team to support the scale and scope of the clinical development programs.
Strong knowledge of FDA medical device regulations, Federal and State law governing clinical research including human subject protection and HIPAA, and experience with IDE Trials.
Knowledge of Good Clinical Practice (GCP) is required.
Demonstrated accomplishment in obtaining medical device product clearances/approvals through CDRH at FDA a plus.
Strong project planning, project management, leadership, negotiation, technical writing and presentation skills as well as an ability to contribute creative yet practical solutions to problems.
Excellent analytical and conceptual abilities, with substantial understanding of statistics and statistical methods.
Performance oriented with ability to work along agreed timelines and a focus on strategy and execution.
Outstanding communicator with excellent problem-solving, conflict-resolution and decision-making skills and an ability to work effectively across all levels of the organization.
Superior writing skills and ability to effectively communicate with technical and non-technical people.
Proficient in MS Office (Word, Excel, PowerPoint) skills.
Masters or Ph.D degree in clinical, science or health-related field
5 years of experience in a leadership role
At least 8-10 years of experience in the pharmaceutical, biological or medical device industry as a clinical research professional, including a successful project leadership role and hands-on managerial experience running clinical trials and managing personnel.
Medical device clinical trial experience and pain trial experience is strongly preferred.
PMA and IDE experience is strongly preferred.
Hands-on experience in development and/or management of investigational sites is preferred.
Must be able to operate a phone, personal computer and other typical office equipment.
Variable overnight travel depending on clinical trial schedule (up to 20% of the time).
Regenesis offers competitive pay, bonus plan, health insurance benefits, matching 401k and a generous paid time off plan.
Regenesis Biomedical is an Equal Opportunity Employer