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Chief Medical Officer
il y a 8 heures
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
This role is open to US and EUR base candidates
Compensation depending upon location
Job Overview
The Chief Medical Officer (CMO) serves as the senior clinical leader at Getinge, responsible for guiding the medical and scientific strategy of the company's product portfolio. This role ensures that all medical device development, regulatory submissions, and post-market activities are grounded in clinical evidence, aligned with patient safety, and compliant with global healthcare standards. The CMO plays a critical role in shaping innovation, supporting regulatory and commercial efforts, leading the Medical Affairs, Clinical Affairs, Professional Affairs and Medical Education groups and serving as the voice of the clinician and patient within the company.
The position is responsible for the development and management of personnel and programs in medical affairs, professional affairs, clinical affairs and medical education. The position is capable of educating and training others.
Job Responsibilities and Essential Duties
- The Chief Medical Officer coordinates the team of Medical Professionals within Getinge to ensure compliance. He/she provides expert medical opinions and recommendations to all departments including Quality and Compliance, Regulatory Affairs, R&D, marketing, and clinical research, and surgeons training, upon request from the respective functions.
- Quality and Compliance
- Responsible to create consistent and clear processes to Medical Affairs across the Getinge businesses, in collaboration with the team of Medical Officers
- Delivers direct physician support to quality assurance group for review of product complaints, MDR reporting criteria, health risk assessments, and product performance criteria.
- Provides medical management of post-marketing adverse events and medical oversight of safety projects.
- Conducts medical review of safety reports and associated QA documentation.
- Reviews and edits protocols to ensure accuracy, consistency with standard of care, logistical ease, and internal consistency with GETINGE requirements.
- Works closely with the Quality, Compliance and Regulatory teams to analyze adverse events and formulate an appropriate response back to the customer as well as if required the Food and Drug Administration.
- Represent the Company with regulatory and legislative agencies, globally addressing the scientific and medical/health aspects of our product portfolio.
Advance R&D:
- Reviews as independent reviewer on internal new technology/products ideas; on surgical techniques and instrumentation -
- Independent medical opinion during early-stage evaluation of external opportunities to support strategic initiatives of Business Development team.
- Suggestions for the application of new technologies in novel ways to solve complex medical device needs.
- Provides independent reviews, obtains, or otherwise provides medical input on content of package inserts instructions for use, brochures, advertisement, products bulletins, literature, etc.
- Continuously maintains thorough and up-to-date knowledge of surgical trends, advances, efficacy of currently available therapies and competitive clinical landscape.
- Provides medical input to legal counsel on product litigation, claims management, investigations, and other matters demanding medical expertise.
Clinical Studies:
- Establish common practice within Getinge on clinical protocols, clinical study-related documents, and clinical study reports.
- Coordinates medical leadership in the evaluation and management of investigator- initiated proposals.
- Review and approve as an independent clinical reviewer, medical hands-on operational support to teams in clinical trial planning, protocol development, investigator selection, training of internal and external personnel, and medical monitoring for trial safety, data analysis/interpretation, and quality control.
Medical Education:
- Manages a team of clinicians tasked to develop and implement customer and patient focused product & clinical education programs.
- Reviews as an independent reviewer and approves product education, promotion, and reporting materials.
- Scientific Advisory Board (SAB) and Experts Relationships
- Cultivates key opinion leader relationships and provides surgical leadership in interactions with advisory board members.
- Attends and potentially participates in National, International, and regional meetings and summaries current medical issues discussed within them to be communicated within the medical community.
Quality System:
- Comply with quality system requirements as defined globally within Getinge, as applicable.
- Responsibility and authority to propose and drive corrections and improvements within the medical affairs area globally.
- Responsibility and authority to act on corrections to Getinge and regulatory policies and procedures.
Required Knowledge & Skills
- Medical Degree is required.
- Minimum of 10 years of clinical experience, with at least 5 years in the medical device industry or related healthcare technology field.
- Minimum 5 year's Corporate experience in a medical device business.
- Proven experience in clinical trial design, regulatory strategy, medical affairs, and clinical education.
- Expertise in cardio-vascular therapies
- Excellent communication, leadership, and cross-functional collaboration skills.
- Strong executive presence. Demonstrated ability to present to and engage at the senior most level of the organization.
- Familiar with clinical research, device development process, regulatory requirements, laws and good clinical practices.
- Understanding of statistical methods
- Effective written & oral communication skills, with the ability to communicate effectively to scientific and non-scientific groups.
- Evidence of a management style characterized by leadership, vision, collegiality, teamwork, preparation, and communication. Capable of leading through others and by participation
- Flexibility and ability to manage simultaneous priorities, changing deadlines, and limited resources.
- Write and understand complex contexts and translate into policies etc.
- Regulatory requirements and standards applicable where Getinge operate
- Strong organizational and interpersonal skills. Strong sense of integrity, responsibility, and urgency.
- Models Getinge's behaviors as established policies and procedures.
- Strong in conducting and follow up/ execution
- Patient-focused mindset. Mission -driven, with passion for improving the lives of patients and their families
- Proven publication and presentation skills.
- Demonstrated experience writing scientific reports
- Travel requirements include 50% domestic and international travel
US BASED SALARY - The minimum base salary for this position is $280,000 and the maximum salary is $375,000 plus 50 % in annual bonus
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About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
