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    Associate Direct/Director, Clinical Operations

    Orchestra Biomed
    7+ years
    Not Disclosed
    Remote, USA
    10 Nov. 14, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Opportunity: Clinical Associate Director/Director at Orchestra BioMed

    About Orchestra BioMed

    Orchestra BioMed is a biomedical innovation company dedicated to accelerating high-impact technologies to patients through risk-reward-sharing partnerships with leading medical device companies. Founded in 2018, Orchestra BioMed focuses on strategic collaborations to drive the successful global commercialization of life-changing products. With a highly accomplished team, Orchestra BioMed develops cutting-edge solutions for conditions like hypertension and atherosclerotic artery disease. The company has partnerships with Medtronic and Terumo for the development of innovative cardiovascular therapies.

    Job Summary

    Orchestra BioMed is seeking a Clinical Associate Director/Director to oversee the implementation and execution of clinical trials in the cardiovascular space. This individual will manage various programs, partner with cross-functional teams, and coordinate the Clinical Operations Team to conduct multinational clinical trials. The ideal candidate will be based in the Philadelphia, New Jersey, New York, or Connecticut region with the option for hybrid work from the New Hope, PA, or NYC office. A remote option may be available for the right candidate.

    Role and Responsibilities

    • Lead the execution of assigned clinical trials in collaboration with Clinical leadership.
    • Manage the clinical operations staff, including Clinical Operations Managers, CRAs, and CTAs.
    • Oversee trial operations, including monitoring, data management, and coordination with external vendors and CROs.
    • Ensure successful implementation of clinical programs, aligning timelines, budgets, and resources.
    • Build and maintain relationships with investigators, physicians, and key opinion leaders.
    • Collaborate with cross-functional teams to forecast supply needs and plan for the duration of the trial.
    • Coordinate trial kick-off meetings and investigator meetings.
    • Track and manage clinical trial budgets, ensuring compliance with financial goals.
    • Maintain strong oversight of CROs and core labs to ensure reliable sponsor oversight.
    • Develop and review study-related documents, such as protocols, informed consent forms, and study manuals.
    • Provide monitoring oversight visits as required and implement corrective/preventive actions.
    • Ensure compliance with GCP, regulatory requirements, and internal SOPs.
    • Work with Safety Vigilance and Regulatory teams to report adverse events to the FDA and other authorities.
    • Travel domestically (approximately 20%) as needed.

    Qualifications – Knowledge & Skills

    • Bachelor’s degree in a biomedical or related scientific discipline.
    • Minimum of 7 years of experience in IND/IDE clinical trials in the cardiovascular device space (preferably in interventional cardiology).
    • In-depth knowledge of GCP, ISO 14155:2020, and Good Documentation Practices (ALCOA+).
    • Strong project management skills, with experience in study planning and the use of project management tools (e.g., Gantt charts).
    • Demonstrated ability to work in a collaborative and dynamic team environment.
    • Excellent written and verbal communication skills.
    • Experience managing clinical teams, CROs, and vendors.
    • Ability to adapt to changing priorities and address unexpected events efficiently.
    • A strong commitment to achieving results and fostering a positive team environment.

    Additional Information

    • Current U.S. work authorization is required.
    • Orchestra BioMed is an equal opportunity employer committed to a diverse and inclusive workforce.
    • Compensation includes a competitive base salary, annual performance-based bonus, equity grants, and a comprehensive benefits package (health, dental, vision, 401(k), and more).

    Orchestra BioMed’s Vision and Mission

    Our vision is to lead in bringing high-impact medical innovations to life through risk-reward sharing partnerships. We are passionate about applying our collaboration-based business model to create extraordinary value for patients, providers, partners, and stakeholders.

    How to Apply

    Interested candidates can apply directly on the Orchestra BioMed careers page. For inquiries, please contact our HR team at hr@orchestrabiomed.com.

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