Field Clinical Director Cardiopulmonary
Dubai, United Arab Emirates
Job Description
Join us today and make a difference in people\'s lives!
LivaNova is looking for a Field Clinical Director for the Cardiopulmonary area for the region Russia & MEA.
LivaNova is looking for a Field Clinical Director for the Cardiopulmonary area for the region Russia & MEA.
The Field Clinical Director leads a team of Field Clinical Managers, which are responsible for training health care professionals in the use of pre and post market medical devices and associated surgical procedures; for installing, upgrading, and troubleshooting the Company\'s products in the field; for programming devices and providing technical expertise in the clinical development of new products. The candidate will perform these duties and develop the necessary training materials in compliance with corporate standards and government/industry regulations.
ESSENTIAL JOB FUNCTIONS
- Take leadership of the field clinical team, leading and managing the individuals within his / her team, providing guidance, support, and feedback, and ensuring that work is completed effectively and efficiently.
- Lead development and implementation of medical education programs to advance the knowledge and skill set of healthcare providers.
- Leads development of internal technical training.
- Develops and implements KOL plan and oversees development of local/market specific KOL plans.
- Reviews business development opportunities for the Region.
- Plans and coordinates International Congresses activities and attendance.
- Runs International Advisory Boards and provides guidance to markets on local advisory board planning and implementation.
- Collaborates with agencies and other vendor partners.
- Provides resource for surgical case coverage, follow-up support and troubleshooting of LivaNova Products.
- Develops departmental plans and goals, including business and/or functional priorities.
Clinical and Technical Support
- Represents LivaNova during surgeries, implants, and device programming.
- Demonstrates expertise in all aspects of implanted medical devices and troubleshooting techniques.
- Provides support and follow-ups in hospitals and clinics, as specified in study protocols or through commercialization efforts.
- Provides support with clinical investigations at clinical centers, including ensuring completion of necessary documentation in accordance with all Company and regulatory standards.
- Receives technical inquiries by telephone. Researches solutions to questions or problems.
- Provides on-call support as needed for surgeries, reprogramming, troubleshooting, follow-up, etc.
- Travel may be extensive, up to 80%
Educational/Research Support
- Educates and trains physicians, hospital personnel and office staff on technical matters relating to LivaNova products.
- Builds professional and technical knowledge by engaging with customers, attending scientific conferences, educational workshops, delivering presentations and training to field personnel and reviewing professional publications.
- Regularly educates and updates physicians/clinicians and clinic follow-up staff on new product releases of device systems and features, including both hardware and software modifications.
- Liaison between R&D and physicians to coordinate beta testing and feasibility studies \xe2\x80\x93 develop protocols and recruit centers.
- Aid physicians with technology \xe2\x80\x93 literature searches, engineering, LivaNova technology.
Internal Support
- Educates and trains LivaNova personnel on technical and clinical matters relating to LivaNova products.
- Maintain open,effective communication with all LivaNova functions, including Regulatory Assurance, Quality Assurance, and Product Development, as well as with employees
- Create and update instructions for use, physician and patient manuals, and other system documentation as required.
- Generate literature/training materials \xe2\x80\x93 create tech memos, facilitate Sales and Marketing personnel with Marketing literature review.
- Assist sales to identify and target physicians.
Medical Expert PDP and Compliance Activities
- Consult on defining clinical/user needs for product development inputs
- Provide expert input on Clinical Strategy and study design
- Clinical evaluation and post-market follow-up planning/reporting. Reviewer and approver.
- Promotional material reviewer and approver
- Consult on providing evidence for promotional claims/ claims matrices
- Risk documents (including harms, severity, occurrence) consultant, reviewer, and approver
- PMS Complaint reviewer
- Clinical study report reviewer and approver
- Clinical Analysis Report (for PMCF clinical activities) reviewer and approver
- Training of internal colleagues involved in product development and compliance activities
- Consult on clinical/medical questions coming from regulators
- Clinical Assessment for adverse events
REQUIREMENTS:
- PhD or medical degree desirable
- Bachelor\xe2\x80\x99s degree in life sciences
- English: excellent spoken & written
- 10+ years experience in healthcare environment
- Prefer prior experience of at least 8+ years as a field clinical manager, technical manager, technology trainer or clinical trainer in medical device field.
- Must have surgical experience.
- Experience in cardiac surgery field desirable
- Demonstrated expertise in fostering solid, value-based physician relationships and a capacity for interacting with patients in a clinical environment
- Demonstrated project management expertise, including resource management/allocation and the ability to successfully manage multiple projects simultaneously
- Demonstrated ability to interpret trends and data, translating the information into actions, opportunities, improvements, and results
- Self-directed, independent thinker with demonstrated ability to manage workload autonomously
- Robust interpersonal skills, with demonstrated ability to build consensus among multiple leadership stakeholders
- Strong written and verbal communication skills
- Excellent presentation skills
- Ability to project a positive image
- Successfully led a Field Clinical or Clinical Education organization to achieve key Objectives
Requirements for Clinical evaluation medical expert approver:
- Knowledge of EU-MDR
- Should have at least the following training and experience in the relevant field: a degree from higher education in the respective field and 5 years of documented professional experience; or 10 years of documented professional experience if a degree is not a prerequisite for a given task.
- Knowledge of: Diagnosis and management of the conditions intended to be diagnosed or managed by the device, knowledge of medical alternatives, treatment standards and technology (e.g. specialist clinical expertise in the relevant medical specialty).
Our commitment to Diversity & Inclusion:
LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination.
Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate\xe2\x80\x99s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.
Background Checks at LivaNova:
Upon successful completion of the hiring process an offer may be extended. Please note, LivaNova reserves the right to conduct background investigations and/or reference checks on all its potential employees, where permitted by local legislation. This offer therefore, is contingent upon a clearance of such a background investigation and/or reference check, and can be rescinded, where permitted by local legislation, based upon data received in the background check and/or refusal to cooperate with or any attempt to affect the results of this check.
Notice to third party agencies:
Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.
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Job Detail
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Job IdJD1589439
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationDubai, United Arab Emirates
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EducationNot mentioned