Director, Medical Affairs
121 Gamma Dr. Pittsburgh, PA 15238 US
PRIMARY PURPOSE: The individual in this position is accountable for fulfilling global medical affairs strategies and tactics. This individual will liaison with Engineering Research and Development for pre-clinical and clinical device testing.
REPORTING: This position reports directly to the Vice President of Medical and Clinical Affairs
SCOPE: Direct reports include all data abstractors, EKG technicians, and data managers. Indirect reports will include the research scientists.
- 50% Maintain subject matter expertise in all aspects of Cardiac devices’ function, performance, indications, and clinical quality measures. Function in the role of a subject matter expert for all internal and external stakeholders.
- 25% Responsible for all aspects of device event analysis and adjudication.
- 10% Collaborate with all aspects of device regulatory reporting.
- 5% Responsible for all technically oriented physician communications regarding device performance.
- 5% Responsible for the Global Medical Affairs strategy and execution covering the full range of Cardiac products and services to include staff, budget, and resource management.
- 5% Contribute to advancing collaborative relationships with key opinion leaders and academic institutions in support of business objectives including working with Clinical Evidence Directors and Sales team.
The individual in this position will: • Develop and execute the Global Medical Affairs strategy. This role will serve as the subject matter expert on all company Cardiac devices and services for both internal and external stake holders. Such functions will include collaborating with Regulatory and Quality Affairs, Legal, R&D, Sales, and Compliance on procedure review and execution.
• Manage and oversee the quality of in house and contracted research data, and outside developers.
• Manage and oversee the quality of data abstractors and clinical trial data management.
• Ensure accuracy and timeliness of device event analyses and reporting required for Regulatory Affairs, Technical Support, Sales, and Corporate Counsel. This includes all aspects of supporting legal actions including appeals and case preparation.
• Assist Regulatory Affairs with mandated clinical reporting and ad-hoc device performance characteristics, including company Metrics.
• Support all facets of Clinical Operations as required.
• Assist Engineering Research and Development in pre-clinical and clinical device testing, provide input into device design/use cases, and monitor / give feedback on commercial device performance.
• Assist Reimbursement in qualifying patients for commercial device use and appealing denials according to Cardiac coverage guidelines.
• Collaborate on science activities from study conception through study publication working directly with the Director of Scientific Affairs and Director of Clinical Operations.
• Provide tertiary support for Sales in answering prescriber questions.
• Conduct individual performance reviews and manage to achieve departmental objectives.
• Be responsible for departmental facets of HIPAA, GLP, GCP, clinical data integrity and security, and code of ethics.
• Oversee and manage questions and issues raised by outside healthcare providers.
• Participate in legal matters related to patients or device related concerns.
• Responsible for monthly departmental performance metrics reporting
• Undertake any additional project assigned by the Vice President of Medical and Clinical Affairs
Qualifications must include: • MD with 5 years of medical device industry or similar experience. Preferable to have experience in cardiology, and also preferable to have experience in practicing clinical medicine.
• Sufficient understanding of FDA regulations and international regulatory requirements, clinical research methods, and biostatistics, as relevant to medical products.
• Demonstratable ability to write and edit original scientific documents such as clinical summaries, investigator brochures, clinical protocols, and internal reports.
• Comfortable working both internally and externally with technical and medical experts in providing input into future product development strategies.
• Significant understanding of electrocardiogram interpretation, particularly rhythm analysis, is required.
• Significant understanding of engineering developmental processes is highly desirable.
• Prior experience with managing teams.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position is generally performed in a typical office environment that is usually quiet. Employee is expected to work collaboratively with team members, as well as able to work independently with limited supervision. Work will require significant computer and telephone work.
15% to 20% travel may be expected both nationally and internationally.
While performing the duties of this Job, the employee is regularly required to sit, talk and hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds.
This position supervises a team of data managers, data abstractors and ECG technicians.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.