Metrex · 3 hours ago
Metrex Clinical Development Manager (Hybrid-Brea, CA)
Metrex is a company focused on infection prevention and control solutions, and they are seeking a Clinical Development Manager to drive clinical strategy and support product development initiatives. The role involves engaging with stakeholders, monitoring market trends, and ensuring that Metrex products meet healthcare standards and regulations.
Health CareMedical Device
Responsibilities
Monitor clinical trends and evidence-based practice trends in infection prevention/control
Track epidemiological trends to inform product development and anticipate future efficacy requirements
Analyze post-market surveillance data and customer feedback to identify opportunities for product improvement and risk mitigation
Develop and deliver clinical practice training programs for Continuing Education Units (CEUs) and manage any staff contracted to develop/deliver educational content
Design and implement ongoing clinical competency development programs for internal teams (sales, PM, marketing, R&D) to ensure up-to-date knowledge of infection prevention science, clinical workflows, and product applications
Create clinical training tools and resources for Metrex products
Manage or support reference account, Key Opinion Leader (KOL) relationships, and clinical advisory boards for Metrex
Participate in industry lobbying efforts and advisory boards to influence standards and guidelines
Lead development of luminary publications, clinical white papers, sponsored studies, and work with leading organizations and key opinion leaders to develop materials to support clinical and marketing efforts
Serve as the Clinical spokesperson in public forums and at key congresses and conferences to drive adoption of Metrex products and solutions
Foster and manage collaborations with international clinical experts, societies, and research institutions to support global product adoption and evidence generation
Collaborate with product management to define clinical requirements for new products
Review and interpret product labeling and Instructions for Use (IFUs) to ensure clarity and compliance with standards of care and current clinical practices
Manage or support clinical trials and/or validations for new product development (as needed) and clinical studies to support clinical market expansion and knowledge
Identify and prioritize unmet clinical needs through collaboration with healthcare professionals and integrate these insights into the product development roadmap
Management of the clinical strategic plan and clinical tactical implementation plans to drive global acceptance of Metrex products and solutions and increase inclusion of Metrex products in medical device instructions for use
Responsible for the Clinical Evaluation Report (CER) under EU Medical Device Regulation (MDR)
Serve as a clinical resource when downstream Metrex sales/clinical personnel are unable to address customer inquiries
Provide scientific expertise for marketing claims, labeling, and customer education
Support medical device instructions for use (IFU) reviews and analysis to support customers in converting to using Metrex products for cleaning and disinfection of their equipment and surfaces
Qualification
Required
Bachelor's degree from a 4-year college or university required in Life Sciences, Microbiology, Public Health, Nursing, or related fields
10+ years of experience in infection prevention, clinical education, or healthcare product development
Familiarity with healthcare facility workflows and infection control practices
Strong knowledge of regulatory requirements and industry standards/guidelines (FDA, EPA, CDC, WHO, APIC, ISO standards) and Good Clinical Practice (GCP)
Excellent communication, analytical, and project management skills
Travel: Occasional travel up to 25% domestically & globally
Preferred
Master's or Ph.D. degree preferred in Life Sciences, Microbiology, Public Health, Nursing, or related fields
Experience with antimicrobial efficacy testing and infection prevention protocols
Ability to engage with KOLs and participate in industry advisory boards
Strong interpersonal skills to effectively work with cross-functional partners on a daily basis
Solid oral, written and presentation skills to effectively communicate and influence a cross functional team
Strong problem-solving skills, ability to thrive in a fast-paced, challenging environment, strong desire to learn
Adaptable & flexible
Effective time management skills to ensure on-time delivery of products and product sustainment
Benefits
Annual performance bonus
Medical/dental/vision benefits
401K match
Company
Metrex
Metrex specializes in infection control, HAI prevention, and more for medical professionals. It is a sub-organization of Danaher.
Funding
Current Stage
Growth StageCompany data provided by crunchbase