Associate Direct/Director, Clinical Operations

Orchestra Biomed - New Hope, PA

Full-time - Mid Level

Remote - New Hope, PA

About the position

The Associate Director/Director of Clinical Operations at Orchestra BioMed will play a crucial role in the implementation and execution of clinical trials in the cardiovascular space. This position involves managing various clinical programs, coordinating with internal teams and external vendors, and ensuring that clinical trials are conducted efficiently and in compliance with regulations. The ideal candidate will be responsible for overseeing the Clinical Operations Team, managing budgets, and fostering effective relationships with investigators and partners.

Responsibilities

• Oversee conduct of assigned clinical trials in partnership with Clinical leadership
• Manage clinical operations staff including Clinical Operations Managers, Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs)
• Drive implementation and execution of assigned clinical programs, including oversight and coordination of all clinical operations
• Direct the clinical team and internal/external resources to achieve established project goals per timeline and within assigned budget
• Establish and maintain effective working relationships with investigators, physicians, and key opinion leaders
• Partner with cross functional departments to establish timelines and forecast supply needs for the duration of the clinical trial
• Assist with the coordination and planning of trial kick-off meetings and investigator meetings
• Establish and track clinical trial budget spending and be accountable for keeping costs within the assigned budget
• Create and establish effective working relationships with CROs and core labs
• Oversee the development of study related documents, including study protocols and informed consent templates
• Conduct monitoring oversight visits as required
• Ensure risk-based implementation of corrective/preventive actions
• Highlight areas for potential improvement and initiate improvement processes
• Partner with Safety Vigilance and Regulatory groups to support appropriate reporting of adverse events
• Ensure that clinical studies are conducted according to GCP and other applicable regulations
• Pro-actively identify process and/or SOP-related obstacles that may impact effective study conduct
• Share accountability with others for a positive team spirit characterized by mutual support and active exchange of ideas

Requirements

• Minimum Bachelors level degree in a biomedical or other relevant scientific discipline
• 7+ years' experience in the conduct of IND/IDE clinical trials in the cardiovascular device space
• Knowledgeable about GCPs, including the standards set forth in ISO 14155:2020
• Strong project management skills, including expertise in the process and methodology used to develop study plans
• Demonstrated ability to work well in a collaborative and dynamic team environment
• Demonstrated superior oral and written communication skills
• Study Management experience required, including management of direct reports and vendors
• Strong interpersonal skills and ability to collaborate effectively with various technical area experts
• Ability to identify and respond quickly to opportunities and difficulties

Nice-to-haves

• Familiarity with Gantt charts or other project management software
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events

Benefits

• Competitive base salary based on experience
• Annual bonus based on exceptional company and individual performance
• Equity grants appropriate for role
• Comprehensive and competitive benefits package including health, dental, and vision insurance
• 401k and other benefits