Field Procedural Specialist

Orchestra Bio Med is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates - Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus Angio Infusion™ Balloon (Virtue SAB) - are currently undergoing pivotal clinical trials for their lead indications which both represent multi-billion-dollar annual global market opportunities.

AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients.

AVIM Therapy has FDA Breakthrough Device Designation for these patients as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind drug delivery angioplasty balloon system designed to deliver a proprietary extended-release formulation of sirolimus, Sirolimus

EFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and below-the-knee peripheral artery disease. The Company has a right of first refusal agreement with Terumo Corporation and Terumo Medical Corporation, a leading global medical device company, for a potential transaction related to Virtue SAB for the treatment of coronary artery disease.

For further information about Orchestra Bio Med, please visit , and follow us on Linked In.

Field Procedural Specialist supports and manages critical trial activities in the field as needed. This individual will be actively involved in identifying potential study centers and building relationships with existing centers, encouraging them to recruit and enroll patients in our study. This person will provide direct technical support to the centers during surgical procedures. Currently, this will include the studies in our Virtue program but may expand as future studies as appropriate.

This key role will be remote and will have significant travel.

• Identify and manage potential study centers to recruit and enroll patients.
• Provide direct support and guidance during technical procedures in OR.
• Plan, coordinate and complete each project on schedule.
• Operate and maintain study related equipment in accordance with establish policies and procedures such as Ambulatory and Office blood pressure equipment.
• Assist in completion of documentation in case record forms during clinical trials, as needed.
• Keeps track and support site performance in terms of patient recruitment and timely response to the company’s requests.
• Maintains documentation regarding any product-related issues.
• Trains medical staff on device related equipment and serves as the first point of contact for any technical questions from the medical team.
• Coordinate scheduling and placement of per diem FCE’s in assign territory.

• Minimum bachelor’s degree in Nursing, biomedical or other relevant scientific discipline.
• 5+ years of related experience working and/or training in Cath Labs in structural heart procedures; scrubbing in cases.
• Experience and/or knowledge of the management of clinical research processes for interventional medical device trials in interventional cardiology trials (experience strongly preferred).
• Good technical skills and excellent computer operating skills including Microsoft office
• Excellent presentation skills in a requirement.
• Cardiovascular anatomy required.
• Demonstrated ability to work well in a collaborative and dynamic team…