Field Procedural Specialist

ORCHESTRA BIOMED, INC.; United States; À distance; USD 75 000 - 110 000; Plein temps

Avantages offerts par ce poste

Health, dental, and vision benefits

401k plan

Résumé du poste

Orchestra BioMed, Inc. is seeking a Field Procedural Specialist to support and manage critical trial activities in the field. The role involves identifying potential study centers, building relationships, and recruiting patients for our Virtue program studies.

The position requires direct technical support during interventional cardiology procedures, coordination of projects, and up to 80% travel. A nursing or scientific background with GCP/ISO 14155 familiarity is preferred, along with strong

Qualifications

• Bachelor’s degree in nursing or relevant clinical field.
• Experience in interventional cardiac cath labs or equivalent.
• Strong imaging experience with IVUS/OCT in interventional cardiology.
• Experience managing clinical research for interventional medical devices.
• Ability to train and consult internal and external teams.
• GCP and ISO 14155 knowledge and application.
• Excellent written and oral communication skills.
• Willingness to travel up to 80% for field activities.

Responsabilités

• Identify potential study centers and build relationships.
• Provide direct technical support during interventional procedures.
• Coordinate and complete projects on schedule.
• Operate and maintain study equipment per policy.
• Assist in documentation for case record forms during trials.
• Track site performance for patient recruitment responsiveness.
• Document product-related issues and train staff on devices.

Connaissances

Nursing degree

Interventional cath labs

IVUS/OCT imaging

Clinical research in medical devices

Training & consultation

Good Clinical Practice ISO 14155

Team collaboration

Communication skills

Travel up to 80%

Formation

Bachelor's degree in nursing or relevant science

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 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.

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, and 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 preferred.
• Experience and/or training working in Interventional Cardiac Cath Labs; or equivalent combination of training in industry required.
• Strong imaging experience is required. Specifically in the interventional cardiac arena working with IVUS/OCT.
• 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.