Director of Clinical Operations - EMEA

CMS

At ZOLL, we\’re passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people\’s lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.

ZOLL Cardiac Management Solutions offers a unique portfolio of novel technologies designed to deliver better insights and better outcomes. On any given day, clinicians utilize these ZOLL products for tens of thousands of cardiac patients around the world:

• LifeVest, the world first wearable defibrillator, has been trusted to protect more than 1M patients at risk of sudden cardiac death.
• HFMS (Heart Failure Management system) is a non-invasive, patch-based device that monitors pulmonary fluid levels and has been shown to reduce heart failure readmissions rates by 38 percent.
• TherOx Super Saturated Oxygen (SSO2) Therapy is the first FDA-approved therapy since the stent 20+ years ago to reduce infarct size in patients with the most severe heart attacks.

Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need.

ZOLL has been Pittsburgh\’s Manufacturer of the Year, one of Western PA\’s Healthiest Employers, and even one of Pittsburgh\’s Coolest Offices. But it\’s our unique opportunity to impact people\’s lives that makes ZOLL the ideal place to build your career.

Job Summary

In this position you are responsible for managing Clinical Operations in the EMEA geographies. This includes managing clinical trial strategy in collaboration with the Medical Affairs Team and Vice President, Medical Affairs and Clinical Operations, including trial design, regulatory strategy and execution, publications strategy and plan.

This is your field of responsibility:

• Responsible for managing clinical trial operational execution, including principle investigator identification and recruiting, enrolling site identification and recruiting, investigator meetings, monitoring, and motivational site visits.
• Responsible for EMEA Clinical budget and headcount.
• Work directly with the finance team to track all research study related costs, budgets, contracts, and forecasts.
• Work directly with the Director of Clinical Operations Global on subject and site enrollment and onboarding projections. Track and mitigate deviations from the plan of record.
• Establish strong clinical relationships within the geography to develop clinical champion network to participate in clinical studies and other evidence based initiatives.
• Manage clinical activity in collaboration with the Medical Affairs and Scientific Affairs Teams with study initiation visits for new clinical study centers, including center recruitment and preparation, facilitating IRB and ethics committee approval processes and preparation for enrollments.
• Manage publications in collaboration with the Medical Affairs and Scientific Affairs Teams and Vice President, Medical Affairs and Clinical Operations, including global strategy, key clinical interest targets, physician author selection and management, and execution.
• Providing initial and transitional education for clinical center personnel and sales representatives on protocol, clinical process, products and applications.
• Understand working relationships with key opinion leaders across functions and be able to leverage relationships to create and execute strategically aligned activities.
• Develop and maintain strong clinical knowledge, critical market insight, and industry awareness to guide strategic decision making.
• This position will have management responsibility over the clinical research associates in EMEA. This includes employees and contractors. Coach/player to research associates.
• Act as a facilitator in cross divisional research activities in the EMEA geography as needed.
• Work directly with the corporate compliance, governance, and privacy team to ensure flawless performance of all research, data usage, and publication activities.

You have the following qualifications:

• Master\’s Degree in a scientific field, Doctorate is preferred.
• Profound experience in cardiology medical device/pharmaceutical industry.

You have the following knowledge, skills and abilities:

• Strong clinical background and the desire to stay current with cardiology therapy trends. Comprehensive knowledge and application of business concepts, procedures and practices. Is recognized as an expert in work group. Job performance in a quality system environment.
• Strong communication skills, comfortable interacting with clinicians and senior management.
• Strong project management skills. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Has broad knowledge of various technical alternatives and their potential impact on the business.
• Ability to handle multiple assignments and perform in a diverse cross-functional team environment.
• Understand business environment and relates extensive knowledge of internal and external activities to trends.
• Interface with a variety of management levels on significant matters, often requiring coordination of activity across organizational units.
• Work is performed under general supervision regarding the direction and progress of projects and special assignments. Receives limited instruction on standard issues, and detailed instructions on new assignments.
• Excellent analytical, strategic thinking and problem solving skills; strong verbal and written communication skills, and well-honed interpersonal and leadership skills are required.
• Ability to interpret and convey clinical data required. Independent thinking and a high level of initiative and the ability to interact well with physician, customers, and key opinion leaders are essential.
• Effective leadership skills in a fast paced, high visibility environment.

Preferred Languages

• English – Expert
• German – Expert

Travel Requirements

• 30% Travel and some weekend work required.

ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients\‘ lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.

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