Associate Director/Director, Clinical Operations - ORCHESTRA BIOMED, INC.

About Orchestra BioMed

Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward-sharing partnerships with leading medical device companies. Orchestra BioMed’s vision is to accelerate medical innovation to patients through risk-reward-sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed is led by a highly accomplished, multidisciplinary management team and a board of directors with extensive experience in all phases of therapeutic device development. Orchestra’s business was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by its founding team. Its flagship product candidates are BackBeat CNT for the treatment of hypertension, the leading risk factor for death worldwide, and Virtue SAB for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic for the development and global commercialization of BackBeat CNT for the treatment of hypertensive patients indicated for a pacemaker and strategic partnership with Terumo for the development and global commercialization of Virtue SAB for the treatment of coronary and peripheral artery disease.

Job Summary

The Clinical Associate Director/Director will assist with the implementation and execution of Clinical trials in the cardiovascular space. This person will manage various programs and will partner with colleagues to build the organization needed to conduct current multinational clinical trials, as well as any future studies that may develop. This person will coordinate and supervise the Clinical Operations Team assigned to the study and coordinate the collaboration with external vendors, including collaborators from CROs and/or consultant clinical support specialists. The ideal candidate will be located in the Philadelphia, New Jersey, New York, Connecticut region with the intention of working in our New Hope, PA, or NYC office in a hybrid capacity.  However, for the right candidate, this role could be remote.

 Role and Responsibilities – Including but not limited to:

• 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), as required.
• Conduct clinical trial operations with a spirit of collaboration and transparency with the OBIO team as well as assigned teams from a strategic partner company.
• Drive implementation and execution of assigned clinical programs, which includes oversight and coordination of all clinical operations including monitoring, data coordination/management and communication between all collaborative partners involved in trial execution.
• 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, including manufacturing, quality and regulatory 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 the cost of all clinical operations within the assigned budget.
• Create and establish effective working relationships with CROs and core labs to provide reliable sponsor oversight.
• Oversee the development of study related documents, including study protocols, informed consent templates, study manuals and plans.
• Hold vendors accountable for deliverables through a high-level oversight approach and seek to avoid duplication of vendor-assigned tasks wherever appropriate.
• Conduct monitoring oversight visits as required
• Ensure risk-based implementation of corrective/preventive actions.
• Highlight areas for potential improvement, initiate improvement process.
• Partner with Safety Vigilance, and Regulatory groups to support appropriate reporting of adverse events to FDA, competent authorities, and regulators.
• Ensure that clinical studies are conducted according to GCP, all other applicable regulations and respect SOP’s and OBIO policies.
• Give input into the continuing development and maintenance of processes and SOPs and adaptation to optimally address the changing internal and external environment.
• Pro-actively identify process and/or SOP-related obstacles that may impact effective study conduct.
• Share accountability with others for a positive team spirit that is characterized by mutual support, understanding, encouragement, and an active exchange of new ideas.
• Travel required domestically (approximately 20%).

Qualifications – Knowledge & Skills:

• 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, preferably in Interventional cardiology.
• Knowledgeable about GCPs, including the standards set forth in ISO 14155:2020.
• Knowledgeable about Good Documentation Practices and ALCOA+ characteristics critical to data integrity
• Strongly goal-oriented and highly motivated with a high energy level.
• Demonstrated ability to work well in a collaborative and dynamic team environment, set priorities, and drive results.
• Demonstrated superior oral and written communication skills and ability to communicate complex issues in a succinct and logical manner.
• Study Management experience required, including management of direct reports (as required) contract research organizations, and vendors.
• 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
• Ability to identify and respond quickly to opportunities and difficulties.
• Strong project management skills, including expertise in the process and methodology used to develop study plans; familiarity with Gantt charts or other project management software used to plan, coordinate, and track tasks in a project.

 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.