Note: The job is a remote job and is open to candidates in USA. Orchestra BioMed is a biomedical innovation company developing high-impact medical technologies through strategic collaborations with medical device companies. The Sr. Director/Director, Field Clinical Engineer will lead the field clinical organization supporting the Virtue clinical trial, including hiring, training, coordination, technical support, and management of field activities at investigational sites.
Responsibilities
- 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%
Skills
- * Min Bachelor's degree
- * 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 c****urrent US work authorization is required in order to be employed by Orchestra BioMed
- Preferably in Life Science, or Nursing, with Cath Lab Tech certification strongly preferred
Benefits
- Annual bonus eligibility
- Equity eligibility
- Health insurance for employee and family
- Prescription drug coverage
- 401(k)
- Paid holidays
- PTO and sick time
- Life and AD&D insurance
- Disability insurance
- Dental insurance
- Vision insurance
- Pet insurance
- Remote work arrangement
Company Overview