Field Procedural Specialist

Orchestra BioMed; Detroit (MI); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

401k and equity

Job summary

Orchestra BioMed in Detroit seeks a Field Procedural Specialist to support critical trial activities in the field. You will identify study centers, recruit patients, and provide direct technical support during procedures. Travel up to 80% and close collaboration with clinical teams are expected.

The role requires a nursing or biomedical degree with 4+ years in interventional cath labs; strong imaging, GCP knowledge, and excellent communication are essential. US work authorization is required.

Qualifications

• Nursing or Biomedical/Bachelor’s degree in a related scientific field is strongly preferred.
• 4+ years of related experience in interventional Cardiac Cath Labs or cardiology trials.
• Strong interventional imaging experience and cardio procedure support.
• Knowledge of GCP and ISO 14155 is expected.
• Excellent written and oral communication; ability to collaborate across teams.

Responsibilities

• Identify and recruit study centers; build relationships to enroll patients.
• Provide direct technical support during surgical procedures.
• Plan, coordinate and complete projects on schedule.
• Document case record forms during clinical trials; maintain site performance data.

Skills

Interventional Cardiac Imaging

Clinical Research

GCP Knowledge

Communication

Team Collaboration

Travel Readiness

Education

Nursing or Bachelor's degree in biomedical/scientific discipline

Tools

Microsoft Office

Job description

Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies. Its partnership-enabled model is designed to drive successful global commercialization of the products it develops in collaboration with these industry leaders. Orchestra BioMed’s lead product candidate is Atrioventricular Interval Modulation (AVIM) Therapy for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing the highly differentiated Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic agreement with Terumo, a global leader in medical technology for development and commercialization of Virtue SAB for the treatment of 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 to future studies as appropriate. The person in this role must live in the Greater Detroit area and must be willing to travel.

Role and Responsibilities – Including but not limited to:

• Partner with key personnel in study centers to recruit and enroll patients.
• Provide Direct technical support during medical procedures.
• Plan, coordinate and complete each project on schedule.
• 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% travel)

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. The actual title will be determined based on experience and education. Duties, responsibilities, and activities may change at any time with or without notice.

Qualifications – Knowledge & Skills:

• Nursing or bachelors degree in a biomedical or other relevant scientific discipline strongly preferred.
• 4+ years of related experience and/or training working in interventional Cardiac Cath Labs
• Must have strong experience with interventional and cardiac imaging.
• Experience and/or knowledge of clinical research processes for interventional medical device (DES, DCB) trials in cardiology trials strongly preferred.
• 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.
• Good technical skills and excellent computer operating skills including Microsoft office
• 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.
• Knowledge of Good Clinical Practice (GCP)
• 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.
• Must be willing to travel up to 80%.
• 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.