Director of Clinical Affairs - Remote

Company:

Our client is the world leader in surgical robotics and is undergoing explosive growth. They are a privately held company with a vision of advancing healthcare through the latest technology and transforming dental surgery with advanced robotics. With an incredibly team-oriented culture this is a company that truly cares about their employees.

Job Summary:

The Director of Clinical Affairs is responsible for overseeing clinical study operations to support FDA clearance/approval, marketing claims, or publications. This role will ensure studies are compliant with regulations, company SOPs, project plans and timelines. This position will oversee multiple, simultaneous studies and have routine interaction with R&D, regulatory, and marketing functions.

Duties/Responsibilities:

• Leads the development clinical evidence strategies to best position the company for successful regulatory approvals, marketing claims and commercialization.
• Design and lead execution of clinical studies for regulatory submissions, reimbursement, and market adoption, including protocol, site recruitment, internal compliance approvals, budget and agreement negotiation, study initiation, trial maintenance, data monitoring, data reporting, vendor selection and management, trial master file maintenance, and product and payment tracking.
• Creates the publication strategy, leads abstract and manuscript writing and submission activities as well as training efforts to understand and interpret available clinical evidence.
• Contributes to writing and review of clinical documents in regulatory agency submissions (IDE, MDR, etc).
• Oversees and/or contributes to the preparation of clinical documents, eg, protocols, investigator brochure, case report forms and clinical study reports, monitoring plans, and budgets.
• Serves as the clinical team expert to provide direction to all project team functions as well as identifies and liaises with IRB, CEC, DSMB and KOLs regarding program strategy and scientific advice.
• Interprets study data and develops integrated summaries for safety and efficacy.
• Utilizes communications, reports, EDC, and CTMS systems to proactively identify potential barriers to project completion and data integrity and proactively implements effective strategies to correct/avoid such barriers.
• Manages External Research proposals- overseeing corporate approval processes, execution of agreements, completion of milestones and reports, and payments or in-kind contributions.
• Contributes to review and approval of risk management plans, design reviews, and IFUs, where clinical input is needed.

Knowledge & Skills Required

• PhD preferred.
• At least 6 years of experience with clinical studies, preferably in medical devices.
• Experience in publishing in high impact medical journals.
• Demonstrated experience in the oversight of clinical trial monitoring, audits and/or inspections.
• Comprehensive knowledge of device clinical trial regulations, guidance, and standard processes.
• Excellent written and verbal communication skills.