Sr. Dir/Dir, Field Clinical Engineer

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^TM Balloon (Virtue SAB) - are currently undergoing pivotal clinical trials for their lead indications, each representing 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 (NYSE: MDT), one of the largest medical device companies in the world, 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. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn.

Job Summary

The Sr. Director/Director will lead Orchestra BioMed’s Field Clinical Specialists driving our Interventional Therapies Clinical Trial, managing critical field activities. The person in this role will act as a player coach who will hire, train, and coordinate logistics for our field team to maximize efficiencies in providing technical support to centers during surgical procedures. 

Success in this position will rely heavily on the ability to utilize experience and judgement to meet the goals and timelines of clinical trial while staying within budget.  Reporting to the VP, Field Clinical, this position will oversee our field team supporting Virtue program, but responsibilities may expand to future interventional studies as appropriate.  This key role is remote and will have significant travel.

Roles and Responsibilities – Including but not limited to:

• Identify, Align, Train and Manage the Field Clinical Organization (employees and consultants) to maximize support for Orchestra BioMed’s Virtue clinical trial.
• Collaborate with leadership and internal partners, including Clinical Operations, Marketing, Regulatory & Quality, HR and others to drive successful execution of clinical trials.
• Develop a system to assign, track, and communicate case coverage logistics supporting case procedures.
• Provide ongoing feedback to company product technical experts to optimize training needs for Field Procedural Specialists organization.
• Train the Field Clinical team on device related equipment.
• Train medical staff at sites on device related equipment, and serve as a point of contact for any technical questions
• Provide direct technical support during surgical procedures.
• Operate interventional product portfolio-related equipment in accordance with established policies and procedures and ensure team members are doing the same.
• Ensure the execution of clinical protocols and procedures as intended at clinical study investigational sites.
• Other tasks may be assigned based on business needs and skillset.
• Travel 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, Associate Director / Director / Sr. Director will be determined based on skills and experience.

Qualifications – Knowledge & Skills:

• Min Bachelor’s degree, Preferably in Life Science, or Nursing, with Cath Lab Tech certification strongly preferred.
• 7+ years of related experience and training working in Cath Labs or equivalent combination of education, and experience.
• 5+ years’ experience managing clinical research process for interventional medical device trials with increasing responsibilities & 7+ years of experience in cardiology trials.
• 5+ years’ Experience in Field Clinical Engineering with knowledge of industry trends and experience in leading and driving operational programs and initiatives.
• 5+ years managing direct reports in field based clinical trials or similar roles.
• Must have excellent presentation and communication skills.
• Interventional Cardiology Disease/therapeutic knowledge/expertise 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
• Demonstrated leadership required to build and maintain a high performance field clinical organization/team and experience in leading clinical trial activities, preferably managing field clinical specialists or similar roles. 
• Exemplary leadership and management skills with ability to foster partnerships in the organization and globally.
• Must be willing to travel up to 80%

A current US work authorization is required in order to be employed by 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.  All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.  The level of this position will be based on the final candidate’s qualifications.

Why Join Orchestra BioMed

In addition to an interesting, inclusive, and collaborative work environment, Orchestra BioMed is proud to offer a comprehensive compensation package.  Along with a competitive salary, including annual bonus and equity eligibility, health insurance (for employee and family), prescription drug coverage, 401(k), paid holidays, PTO & sick time, Life & AD&D insurance, disability insurance, dental, vision, pet insurance and more.

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

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.

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.