Director, Preclinical Research

Job Title: Director, Preclinical Research

CardioFocus is recruiting for a Director, Preclinical Research, based in Marlborough, MA.

CardioFocus is an innovative medical device company working on the next generation of cardiac ablation systems and is known as the world leader in endoscopically guided treatment of AF. CardioFocus offers a collaborative work environment in a rapidly growing field with the opportunity to bring new technologies that will impact the lives of millions suffering from cardiac arrhythmias.

The Director, Preclinical Research will lead strategy and execution for the preclinical evidence necessary to competitively position CardioFocus' products for domestic and international regulatory and clinical acceptance. This individual will draw upon multiple engineering and scientific disciplines including computational and systems modeling, bioengineering and veterinary sciences to drive high quality internal and external preclinical studies. This leader will focus on developing best in class tools and processes as well as mentoring internal scientific and engineering staff to support and accelerate innovation in electrophysiology.

The Director, Preclinical Research, will serve as a member of the R&D/Clinical leadership team as a key partner in driving innovative product development. This highly visible role will influence executive strategy and play a critical role in developing best practices for clinical outcomes. Responsibilities include:

• Demonstrate execution excellence and deliver preclinical evidence to offer differentiated value to advance innovation.

• Develop robust preclinical plans and evidence-based strategies for an aggressive R&D portfolio that minimizes risk to product approvals, ensures patient safety, and increases product adoption to our customers.

• Work cross-functionally with Clinical, Regulatory, Quality and Medical Affairs to identify and understand potential patient risks associated with products and then develop preclinical plans that meet project timelines.

• Provide scientific input and rationale for the highest potential projects in CardioFocus to effectively direct and utilize available resources.

• Develop and direct teams to execute preclinical plans and deliver preclinical evidence for both internal regulatory needs and external publication plans.

• Connect externally and engage strategically with, regulators, customers, thought leaders, academia, CROs and other external partners to anticipate industry trends and unmet needs, facilitate innovation, enhance product development and physician testing of CardioFocus products in preclinical studies.

• Provide strong people management skills and organizational leadership. Develop and strengthen the preclinical talent pipeline.

Qualifications:

An advanced degree (i.e. MS, PhD, PharmD, DVM, MD, etc.) in science or engineering disciplines is strongly preferred.

A minimum of 8 years of experience in a medical device and/or contract research organization is required.

A minimum of 3 years of experience managing or mentoring scientific staff is required.

Scientific knowledge and experience in developing therapies for electrophysiology applications is required.

Experience with managing preclinical and/or clinical studies, including GLP, with external contract research organizations is required.

Track record of new product introduction and product life cycle management is required.

Knowledge of preclinical regulatory requirements for FDA, EU, and other international agencies is required.

Ability to work both collaboratively as a team across various functions in a challenging and changing environment is required.

Familiarity with Medical Device Product Development is preferred.

Business travel of up to 25% is required.

CardioFocus is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job's end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

Please submit your resume and cover letter to: careers@cardiofocus.com

FIELD CLINICAL SPECIALIST

Job Title: Field Clinical Specialist

Department: Sales / Field Support

Job Reports To: Managing Director

FLSA: Exempt

Scope:

Working with the US Sales & Marketing team in a collaborative and cross-functional setting, the Field Clinical Specialist will participate with the US Sales & Marketing team in the field support and education using the Company's unique Endoscopic Ablation System in the treatment of patients with atrial fibrillation (AF).

Responsibilities:

• Support US physicians and hospital staff when using the HeartLight Ablation system to treat AF according to industry standards and the product IFU

• Support new site launches of the HeartLight catheter and console for ablation of atrial fibrillation in the US

• Support communication with US Territory Managers and the Marketing team

• Support selection of new centers

• Support site personnel training on the use of the Company's products according to the industry standards and the product IFU

• Support site communication for device shipments and cases

• Verify proper device shipment, accountability and disposition

• Provide product feedback when necessary, including implant case report forms (CRFs) and complaint handling

Requirements:

• Four year engineering degree preferred

• At least 1-2 years of hospital experience, ideally in the EP lab conducting ablations

• At least 1 years working for a medical device EP company supporting clinical cases of AF pulmonary vein isolation (PVI) ablation or similar experience

• Prior positive relationships with AF ablation centers in the US preferred

• Ability to work in fast paced dynamic setting

• Excellent interpersonal, organizational, and critical thinking skills; able to interface with leading thought leaders in the field of AF ablation

• Positive, self-motivated, creative, detail oriented team player

• Travel: Up to 70%

• Able to withstand physical requirements of supporting AF cases while wearing lead

• Able to withstand physical requirements of travel

The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job's end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

Please submit your resume and cover letter to: careers@cardiofocus.com