KMO Director, Clinical Affairs (Brea, CA)

About the Role

This senior-level leadership position bridges clinical strategy, medical/dental affairs, and regulatory/commercial functions. The Director of Clinical Affairs is responsible for defining and executing the overall clinical strategy in Restorative, Endodontics, Orascoptic, and Disinfection, ensuring all studies adhere to regulatory standards for medical devices. Under the EU Medical Device Regulation (MDR 2017/745), the role owns and oversees clinical evidence, lifecycle management, and regulatory expectations using a risk-focused, evidence-driven approach for CERs, PMCF studies, and PMS reports. The position actively contributes to the innovation pipeline by identifying opportunities, evaluating concepts, and supporting end-to-end product development.

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 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 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.
• Evaluate new technologies, indications, or acquisitions.
• Identify and establish relationships with research institutions, universities, industry experts, and Key Opinion Leaders to drive 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.
• Collaborate cross-functionally with R&D/Product Development, Marketing, and Quality & Regulatory teams.
• Establish processes, SOPs, and best practices.

Requirements

• Doctor of Dental Science (DDS) or similar degree with an advanced degree (MS, MSD, PhD) required (US DDS is required).
• 5+ years in clinical affairs, medical affairs, or clinical development, with leadership experience in managing clinical programs or medical/dental strategy.
• Experience supporting compliance with FDA, ISO 13485, MDSAP, EU MDR, and GMP.

Skills

• Outstanding communication skills, detail-oriented, and efficient in time management.
• Strong medical expertise, regulatory knowledge, project management, and cross-functional leadership.
• Strong interpersonal and teamwork skills.
• Experience using Microsoft Office (Word, Excel, PowerPoint) to prepare charts, tables, forms, reports, and presentations.
• Ability to work both independently and as part of a team.

Pay

The total compensation package for this position ranges from $177,300 to $216,700. Actual compensation considers factors such as geographic location, skill sets, education, certifications, depth of experience, performance, and business needs. The range has not been adjusted for geographic differentials. The position may also include an annual performance bonus, medical/dental/vision benefits, and a 401K match.