KMO Director, Clinical Affairs (Brea, CA)

JOB SUMMARY:

Director, Clinical Affairs is a senior-level leadership position that bridges clinical strategy, medical/dental affairs, and regulatory/commercial functions.

The Sr. Clinical Research Manager is responsible for defining and executing the overall clinical strategy in Restorative, Endodontics, Orascoptic and Disinfection and making sure that all studies follow regulatory standReards for medical devices.

Actively contribute to the innovation pipeline by identifying opportunities, evaluating concepts, and supporting end-to-end product development.

Under the EU Medical Device Regulation (MDR 2017/745), the Director of Clinical Affairs will own and oversee the clinical evidence, lifecycle management, and regulatory expectations in risk-focused evidence driven approach for CER’s, PMCF’s and PMS reports.

PRIMARY DUTIES & RESPONSIBILITIES:

• Provide leadership for clinical strategy and vision, overseeing clinical trials, scientific direction, cross‑functional collaboration, and regulatory compliance.
• Develop and execute medical/dental strategy aligned with product lifecycle stages, ensuring alignment with clinical development, regulatory, and commercial goals.
• Support regulatory submissions with regulatory affairs and ensure compliance with clinical and regulatory standards.  Provide clinical input for IDE, IND, PMA, 510(k), or CE marking dossiers.
• Oversee clinical trial execution, data review, safety monitoring, and protocol development, often in collaboration with clinical development, biostatistics, and medical operations in accordance with Good Clinical Practices and ISO 14155.
• Serve as the primary medical/dental contact for investigators, ethics committees, and regulatory authorities; represent the company in advisory boards and scientific meetings.
• Partner with commercial, and product management teams to integrate medical/dental insights into market access and go-to-market strategies.
• Manage budgets, study progress, timelines, and track performance metrics, to ensure efficient trial execution.
• Manage CROs, study sites, investigators, and vendors.
• Identify gaps in clinical evidence and plan studies to address them.
• Develop and execute clinical evidence plans (pre- and post-market).
• Conduct post-market clinical follow-up (PMCF) or Phase IV studies.
• Support ongoing safety and performance evaluations.
• Serve as a clinical voice in executive decision-making.
• Actively contribute to the innovation pipeline by identifying opportunities, evaluating concepts, and supporting end-to-end product development. Evaluate new technologies, indications, or acquisitions.
• Identify and establish relationships with research institutions, universities, industry experts and Key Opinion Leaders as needed for driving clinical affairs activities.
• Lead scientific publications, abstracts, and presentations.
• Ensure data supports claims, safety, and effectiveness.
• Monitor patient safety and risk/benefit throughout clinical programs.
• Review adverse events and ensure proper reporting
• Contribute to risk management and post-market surveillance activities
• Cross-functional collaboration with R&D/Product Development, Marketing and Quality & Regulatory teams.
• Establish processes, SOPs, and best practices.