Medical Director

ZOLL Medical is a growing, innovation-driven company at the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of ZOLL employees, and we’re invested in their success.

The Circulation team is focused on “beating heart” therapies for hospitals.  Post-cardiac arrest, STEMI heart attack, and severe fever are some of the applications of ZOLL’s unique devices.  Fully integrated, ZOLL Circulation research, develops, manufactures, and sells novel technologies includes ZOLL Temperature Management Solutions and TherOx SSO2 Therapy.  Temperature Management Solutions empower physicians to “prescribe” a temperature and achieve it.  TherOx 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.

We offer competitive salaries and a comprehensive benefits package. Join our team. It’s a great time to be a part of ZOLL!

The Medical Director will report directly to the president of ZOLL Circulation and be responsible for the strategy and direction of the company’s clinical initiatives. They will be a key member of the senior management team, serving as the clinical and scientific ambassadors working to educate and develop relationships with clinicians, researchers, and other healthcare professionals. The role is global and primarily field-based, supporting both TherOx and Temperature Management businesses while working with the clinical and commercial teams to drive therapy adoption at every site.  Leveraging a strong clinical research and practice background, they will answer challenging questions about how our technology works, discuss technology integration into daily practice and give scientific presentations at conferences and ZOLL-hosted events.  The Medical Director will also work with R&D and Clinical Affairs to play an integral role in shaping both clinical-regulatory strategy and product pipeline efforts in order to maximize the full potential of our portfolio.

Essential Duties and Responsibilities:

• Assure medical/scientific integrity and strategic alignment of clinical development programs and their deliverables.
• Design, develop, and implement clinical studies that support our strategic plan.  Interact with principal investigators and opinion leaders to facilitate the research.  Develop and participate in the writing and review of protocols, investigator brochures, study reports and other clinical and regulatory documents. 
• Provide field support to current studies in order to drive study site activation, engagement, and patient enrollment.
• Support the development of Investigator Sponsored research and lead the review of requests for grants and sponsorships.
• Participate in the development and review of publications.
• Provide scientific oversight for clinical operational staff, contract research organizations (CROs), and clinical trial sites.
• Proactively establishes and maintains strong relationships with investigators and key opinion leaders within multiple clinical disciplines, including cardiology, emergency medicine, and critical care communities as well as other relevant healthcare professionals
• Act as clinical subject matter expert for both Company team members and for external contacts.  Develop and give internal and external presentations.
• Orchestrate and manage clinical aspects of regulatory strategies and interactions with Health Authorities and regulatory agencies.  Participate in clinical study report conceptualization, development and writing for global regulatory submissions
• Provide feedback and approval for education and marketing material for healthcare providers and patients
• Work closely and collaboratively with other functions, e.g. clinical affairs/operations, medical affairs, R&D, quality, sales and marketing
• Represent the Company and its programs to external audiences, including the investment, medical and regulatory communities, as well as industry collaborators/partners
• Excellent communication, interpersonal and presentation skills and ability to present concepts and clinical trial results to a variety of audiences, including medical and scientific peers, advisory boards, company and department personnel
• Able to work effectively in a small dynamic organization; ability to assume multiple roles and responsibilities and meet aggressive goals

• Positive approach to work and ability to inspire a sense of urgency in team members to meet timelines and project goals is required. High degree of planning ability in coordinating the activities of Clinical Development teams within the limits of clinical research schedules and ability to support aggressive timelines

Qualifications:

The ideal candidate will possess:

• MD with Board Certification in Cardiology with a proven track record of research and publications
• 10 years minimum experience in clinical practice treating patients preferred
• Strong background and interest in the underlying science and mechanism of action of therapies is required. Prior experience in translational research is strongly preferred.
• A proven record in Phase I-IV clinical research studies and trial design
• Experience in early-stage medical device development and therapy awareness is desirable
• Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience in interactions with FDA personnel is essential; experience in interactions with other health authorities a plus
• Management experience leading a clinical group including clinical/medical affairs and clinical operations
• Must have a thorough knowledge of clinical research concepts, practices, and GCP Guidelines
• The successful candidate will read, write and speak fluent English, possess excellent communication skills, and will be capable of articulating the Company’s clinical and regulatory strategies and progress to a wide internal and external audience.
• Must have excellent leadership and interpersonal skills; should have proven skills as an effective team player who can engender credibility and confidence within and outside the company; must have outstanding executive presence.
• Must be science- and data-driven
• For best fit, the candidate must have the ability and strong desire to “make things happen”