The Director of Clinical Research is the leader of our clinical research program reporting directly to the CEO. This position will have full responsibility for the small department, including development and implementation of the clinical trial strategy, directing all clinical study activities, and ensuring good clinical practices are in place. Ensures efficient execution of trials within established budgets and timelines, and compliance with appropriate regulations, including FDA, privacy, IRB, 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.
ESSENTIAL DUTIES & RESPONSIBILITIES
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 and present to 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.
Oversees activities leading to GCP audits and regulatory inspections related to clinical trial conduct.
Ensures adherence of the clinical team to IRB, 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 ability to lead a small, medical device company clinical department.
Demonstrated ability to cooperate, collaborate, and communicate with a variety of positions within the Company and with external partners.
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 good 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 departments and levels of our organization.
Superior writing skills and ability to effectively communicate with technical and non-technical people. Previous record of peer-reviewed publications a plus.
Proficient in MS Office (Word, Excel, PowerPoint) skills.
Experience writing grant applications for external funding.
Proficiency in statistical software.
EDUCATION, EXPERIENCE & TRAINING REQUIRED
Masters or Ph. D degree in clinical, science or health-related field
5 years of experience in a leadership role of clinical teams and programs throughout the trial life cycle.
At least 8-10 years of experience in the medical device, biological or pharmaceutical 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 or wound trial experience is strongly preferred.
PMA and IDE experience are strongly preferred.
Hands-on experience in development and/or management of investigational sites is preferred.
PHYSICAL POSITION REQUIREMENTS
Must be able to operate a phone, personal computer, and other typical office equipment.
Variable overnight travel depending on clinical trial schedule (up to 40% of the time).
Position may be somewhat remote, with regular visits to the corporate office.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Regenesis offers competitive pay, bonus plan, stock plan, health insurance benefits, matching 401k, and a generous paid time off plan.
Regenesis Biomedical is an Equal Opportunity Employer
Internal Number: 1011
About Regenesis Biomedical, Inc.
Regenesis Biomedical (www.regenesisbio.com), is a privately held company focused on noninvasive regenerative medicine. Located in Scottsdale, Arizona, Regenesis has developed, patented, and now makes the Provant® Therapy System. The company was founded back in 1997 by two N.I.H. scientists who became very interested in the potential for pulsed electromagnetic field energy. Provant® Therapy delivers electromagnetic energy which reduces post-operative pain and edema. The Regenesis environment exemplifies the Company’s core values of dedication, innovation, integrity, respect, excellence, compassion and teamwork.