התפקיד במילים פשוטות
התפקיד כולל ניהול מקצה לקצה של פרויקטים קליניים עבור פלטפורמות אסתטיקה רפואית, החל משלב המחקר המוקדם ועד לניסויים קליניים ואיסוף ראיות לאחר שיווק. מנהל או מנהלת התפקיד יובילו הערכות קליניות ומדעיות, יגדירו דרישות קליניות לפיתוח מוצרים, וישתפו פעולה עם ממשקים רבים בארגון ומחוצה לו.
- Bachelor's degree in life sciences, biomedical engineering, medical sciences, biotechnology, or a related field
- Minimum of 5 years of experience in clinical project management
- Hands-on or demonstrated experience with pre-clinical testing, laboratory evaluations, pre-clinical study design, product performance evaluations, or validation activities
- Proven track record of managing clinical studies, validation activities, or cross-functional development projects simultaneously
- Strong knowledge of Good Clinical Practice, clinical research regulations, and applicable regulatory requirements
- Advanced degree in life sciences, biomedical engineering, medical sciences, biotechnology, or a related field
חולץ מתיאור המשרה · מתעדכן אוטומטית
למי זה מתאים
התפקיד מתאים לבעלי תואר ראשון לפחות במדעי החיים, הנדסה ביו-רפואית או תחום קרוב, עם ניסיון של חמש שנים לפחות בניהול פרויקטים קליניים בתעשיית המכשור הרפואי או הפארמה. הוא פחות יתאים למי שאינו מעוניין בנסיעות לחו"ל או למי שאין לו ניסיון מעשי בבדיקות פרה-קליניות ובהיכרות עם תקני GCP.
תיאור המשרה המלא
המשרה המקורית · נשמר לעיוןLumenis is a global leader in energy-based solutions for Aesthetics and Eye Care. Headquartered in Yokneam, Israel, with offices in Tel Aviv, Lumenis has a strong global presence and business performance worldwide. We are looking for a Clinical Manager to join our Aesthetics Business Unit, which includes a broad portfolio of leading market solutions as well as an exciting innovation pipeline. The Clinical Manager will be responsible for pre-market and post-market clinical activities for the assigned platform, including defining clinical requirements to guide design input, leading pre-clinical validation planning and execution, providing clinical input to regulatory submissions, supporting market conditioning for new solutions, generating post-market clinical evidence, and developing relationships with key opinion leaders. This role is a key pillar in demonstrating the clinical value, safety, performance, and benefits of Lumenis solutions, while strengthening relationships with global KOLs, clinical investigators, and cross-functional stakeholders. Key responsibilities: • Develop and manage end-to-end clinical project plans, timelines, and budgets, from early clinical research and pre-clinical validation through clinical trials, publications, user guidelines, and post-market evidence generation. • Drive cross-functional collaboration across multiple interfaces and business units. • Conduct deep clinical and scientific assessments, including review of the standard of care, clinical trends, mechanism of action, and emerging technologies, to support current and future product development and innovation. • Define pre-clinical validation strategies and lead pre-clinical evaluation activities • Lead the strategy, planning, and execution of clinical studies, ensuring adherence to study protocols, ethical requirements, Good Clinical Practice, regulatory requirements, timelines, and budgets. • Form and cultivate strong collaborative relationships with cross-functional partners in R&D, product management, marketing, regulatory affairs, quality assurance, clinical training, and regional commercial teams. • Lead clinical input and support for key regulatory submissions and processes, including clinical rationales, clinical validations, clinical evaluation reports, and clinical development plans. • Support marketing and commercial activities from a scientific and medical perspective, including review and input into marketing collateral, development of white papers, clinical summaries, presentations, training materials, and active participation in scientific meetings. • Communicate project status to stakeholders, providing clear updates on milestones, deliverables, risks, mitigation plans, and key decisions.
Requirements: • Bachelor's degree in life sciences, biomedical engineering, medical sciences, biotechnology, or a related field; advanced degree preferred- • Minimum of 5 years of experience in clinical project management within the medical device or pharmaceutical industry. • Hands-on or demonstrated experience with pre-clinical testing, laboratory evaluations, pre-clinical study design, product performance evaluations, or validation activities for medical devices. • Proven track record of managing clinical studies, validation activities, or cross-functional development projects simultaneously. • Strong knowledge of Good Clinical Practice, clinical research regulations, and applicable medical device regulatory requirements. • Familiarity with medical device quality systems, design control processes, risk management, and clinical evaluation documentation. • Excellent organizational and leadership skills, with the ability to work under pressure, manage competing priorities, and drive projects to completion. • Strong written and verbal communication skills, with the ability to present scientific and clinical information clearly to both technical and non-technical audiences. • Fluent English, written and spoken. • Willingness to travel globally, approximately 15%.
שאלות על המשרה
- המשרה לא ציינה שכר. אנחנו מציגים שכר רק כשהמעסיק מפרסם אותו.
- מרחוק
- Bachelor's degree in life sciences, biomedical engineering, medical sciences, biotechnology, or a related field, Minimum of 5 years of experience in clinical project management, Hands-on or demonstrated experience with pre-clinical testing, laboratory evaluations, pre-clinical study design, product performance evaluations, or validation activities, Proven track record of managing clinical studies, validation activities, or cross-functional development projects simultaneously, Strong knowledge of Good Clinical Practice, clinical research regulations, and applicable regulatory requirements