Field Procedural Specialist

Orchestra BioMed; Cincinnati (OH); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive base salary

Annual bonus

Equity grants

Benefits package: health, dental, and

401k

Job summary

Orchestra BioMed is seeking a Field Procedural Specialist to support and manage pivotal trial activities in the field. The role involves identifying potential study centers, building relationships, and recruiting patients, with direct technical support during surgical procedures.

The ideal candidate has a nursing or related scientific degree, 3+ years in interventional cardiology trials, and strong GCP/ISO14155 knowledge, plus excellent communication and teamwork.

Qualifications

• Bachelor’s degree nursing or related scientific discipline required.
• 3+ years of Interventional Cardiac Cath Lab experience or equivalent.
• Experience in managing clinical research processes for interventional medical device trials.
• Knowledge of Good Clinical Practice (GCP) and ISO 14155.
• Excellent written and verbal communication, training and collaboration skills.
• Willingness to travel up to 80% and reside within the posted city area.
• US work authorization is required.

Responsibilities

• Recruit and enroll patients at study centers.
• Provide direct technical support during interventional cardiology procedures.
• Plan, coordinate and complete projects on schedule.
• Operate and maintain study-related equipment.
• Assist in documentation in case report forms during trials.
• Track site performance and respond to company requests.
• Maintain documentation of product-related issues.
• Train medical staff on device-related equipment and serve as point of contact for technical questions.
• Travel up to 80%.

Skills

Cath Lab experience

Clinical research

GCP ISO 14155 knowledge

Strong communication

Travel up to 80%

Microsoft Office

Team collaboration

Training skills

Education

Bachelor’s degree in nursing or related science

Tools

Medical device equipment

Job description

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 Virtue® Sirolimus 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. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn.

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 key role must live within 15 miles of the city where this job is posted and will have significant travel.

Role and Responsibilities – Including but not limited to:

• Partner with study center colleagues to recruit and enroll patients.
• Provide Direct technical support during interventional cardiology procedures where applicable.
• Plan, coordinate and complete each project on schedule.
• Operate and maintain study related equipment in accordance with establish policies and procedures.
• 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.
• Road Warrior level travel required (Up to 80%).

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:

• Bachelor’s degree nursing or other relevant scientific discipline strongly preferred.
• 3+ years of related experience and/or training working in Interventional Cardiac Cath Labs; or equivalent combination of education and experience required.
• Experience and/or knowledge of the management of clinical research processes for interventional medical device trials with years of experience in cardiology trials strongly preferred.
• Experience providing expert level consultation and training to Internal and External colleagues.
• Strong imaging experience is required.Specifically in the cardiac arena
• Basic physiological knowledge is desirable.
• 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.
• Experience using Microsoft office
• Strongly goal-oriented and highly motivated with a high energy level.

A current US work authorization is required. 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

Important notice to employment businesses/agencies

Orchestra BioMed does not accept referrals from employment agencies unless written authorization from the Orchestra BioMed Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore Orchestra BioMed will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at Orchestra BioMed.