Associate Director, Clinical Research
About The Position
Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with aortic diseases. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com . Position Overview: Lead assigned departmental projects and tasks, which are identified below for aortic arch repair technologies, including execution of investigational device exemption (IDE) studies and post-approval studies.
Requirements
- Minimum 8+ years of experience, within the medical/biomedical industry.
- Minimum 3+ years of experience in a leadership / management role.
- Bachelor’s and/or Master’s degree in a related field.
- Deep knowledge of ICH-GCP guidelines, FDA/EMA regulations, and global clinical trial processes.
- Proven ability to lead cross-functional teams and manage vendors.
- Excellent written and oral communication skills.
- Ability to manage multiple projects.
- Demonstrated computer skills with Microsoft Office.
- Clinical research professional certification or certification eligible.
Nice To Haves
- Experience working on IDE studies is highly desirable.
- Experience with cardiac or aortic disease is highly desirable.
Responsibilities
- Drive clinical strategy through the development, implementation, and refinement of global clinical strategies and clinical development plans for assigned projects.
- Accountable for clinical components of regulatory submissions (e.g., IDE, PMA, HDE, etc.), ensuring compliance with ICH-GCP and international regulatory requirements to achieve approvals.
- Oversee the development, review, and approval of clinical protocols, Investigator Brochures, informed consent forms (ICFs), and Clinical Study Reports (CSRs).
- Develop and maintain integrated, high-level project timelines, ensuring adherence to key milestones and proactively mitigating risks.
- Oversee site selection, qualification, initiation visits, and investigator engagement strategies.
- Serve as a point of escalation for clinical vendors (ex. CROs) and surgeon consultants.
- Oversee the integrity of clinical data collection, analysis, and external reporting, ensuring alignment with study plans.
- Directly manage Clinical Project Managers (CPMs), mentoring for personal growth, engagement, and ensuring high performance.
- Provide "dotted-line" leadership to cross-functional subject matter experts (e.g., data management, biostatistics, medical writing, etc.).
- Manage multi-million-dollar project budgets, including forecasting, monthly accruals, and variance analysis.
- Drive inspection readiness and act as a key stakeholder during regulatory audits.
- Plan and oversee the development of peer-reviewed publications, posters, and abstracts based on study findings.
- Ensure successful management of study committees, including Steering Committee, Data and Safety Monitoring Board and Clinical Events Committee.
- Ensure collaboration amongst Core Team members, including review and approval of documents owned by other departments including but not limited to marketing, regulatory, R&D, and quality.
- Attend surgical congresses in person or remotely, as necessary.
- Other assigned responsibilities (including previously identified tasks being performed at a higher level than one’s current title).
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
