Field Procedural Specialist

ORCHESTRA BIOMED, INC.; Detroit (MI); Sur place; USD 85 000 - 115 000; Plein temps

Avantages offerts par ce poste

Health, dental, and vision insurance

401k plan with company match

Annual bonus program

Equity grants

Résumé du poste

Orchestra BioMed is seeking a Field Procedural Specialist to support pivotal clinical trials and ongoing device studies. You will identify centers, provide technical support in OR settings, and ensure study milestones are met across a travel‑heavy territory. This role requires living near a major airport and significant travel.

The candidate will bring 5+ years in cath labs, familiarity with GCP/ISO 14155, and strong communication skills to train staff and coordinate across sites.

Qualifications

• Minimum bachelor’s degree in nursing, biomedical or other relevant scientific discipline.
• 5+ years of related experience working and/or training in Cath Labs; scrubbing in cases.
• Experience with clinical research processes for interventional medical device trials in interventional cardiology trials.
• Good technical skills and excellent computer operating skills including Microsoft Office.
• Cardiovascular anatomy knowledge required.
• Demonstrated ability to work in a collaborative team and drive results.
• Knowledge of Good Clinical Practice (GCP) and ISO 14155.

Responsabilités

• 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 per policy and procedures.
• Assist in documentation in case record forms during clinical trials.
• Monitor site performance in patient recruitment and response to requests.
• Maintain documentation on product-related issues.
• Train medical staff on device equipment and serve as first point of contact for technical questions.
• Coordinate scheduling and placement of per diem FCEs in territory.
• Travel 60%+; Road Warrior level travel required.

Connaissances

Cath Lab experience

GCP knowledge

Communication skills

Analytical thinking

Formation

BSN or related field

Outils

Microsoft Office

Description du poste

About Orchestra BioMed

Orchestra BioMed 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 VirtueSirolimus AngioInfusion 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, SirolimusEFR, 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.

Job Summary

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. The person in this position must live near a major airport and will have significant travel.

Role and Responsibilities – Including but not limited to:

• 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 established 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.
• Keep track and support site performance in terms of patient recruitment and timely response to the company's requests.
• Maintain documentation regarding any product-related issues.
• Train medical staff on device related equipment and serve as the first point of contact for any technical questions from the medical team.
• Coordinate scheduling and placement of per diem FCEs in assigned territory.
• Road Warrior level travel required (over 60%).

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of an employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Actual Title, FCE, Sr FCE, Principal FCE will be determined based on experience.

Qualifications – Knowledge & Skills

• Minimum bachelor’s degree in nursing, biomedical or other relevant scientific discipline.
• 5+ years of related experience working and/or training in Cath Labs; 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 is required.
• Demonstrated ability to work well in a collaborative and dynamic team environment, set priorities, and drive results.
• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly, and conclusions are adequately supported by data.
• Demonstrated superior oral and written communication skills and ability to communicate complex issues in a succinct and logical manner.
• In-depth knowledge of Good Clinical Practice (GCP) and Clinical investigations of medical devices for human subjects (ISO 14155).
• Familiarity with the standards set forth in ISO 14155.
• Strong interpersonal skills and ability to collaborate effectively with various technical area experts.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
• Demonstrated effective communication, interpersonal and negotiating skills.
• Analytical thinking – systematic gathering, organization and synthesizing of relevant information.
• Results achievement – ability to identify and respond quickly to opportunities and difficulties, or to take action to accomplish including organizing future intended action.
• Knowledge-Industry/Business/Clinical – knowledge and understanding of the business, its vision, mission, strategies, products, procedures, and services as well as of the trends impacting the medical device industry.
• Strongly goal‑oriented and highly motivated with a high energy level.

Current and ongoing U.S. work authorization is required to be employed with Orchestra BioMed. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. The level of this position will be based on the final candidate’s qualifications. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

EQUAL OPPORTUNITY EMPLOYER

Orchestra BioMed is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information, and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.

Orchestra BioMed has a multi‑part and competitive compensation structure:

• Competitive base salary based on experience.
• Annual bonus based on exceptional company and individual performance.
• Equity grants appropriate for role.
• We offer a comprehensive and competitive benefits package which includes health, dental, and vision, 401k as well as other benefits.

Our Vision

To be a leader in bringing high impact medical innovations to life through risk-reward sharing partnerships.

Our Mission

We will work passionately to apply our collaboration-based business model to bring high-impact medical innovations to live and create extraordinary value for patients, care providers, partners, and stakeholders.

Our Values

We care about patients, physicians, partners, and each other.

We are creative, open‑minded, adaptable and think “outside the box.”

We are driven to always do our best and we do not give up.

We deliver and are accountable to promised results.