Reference Number: JO-2001-444279
Associate Director- Clinical Affairs
Job Type: Permanent
Location: United States
An Associate Director of Clinical Affairs is required to develop and manage the clinical affairs function (in the Medical Affairs Department) in support of Interventional Surgery product development and overall business objectives.
A global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company provides innovative solutions that help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures and support the management of diabetes.
The Associate Director provides strategic direction for clinical evaluation of products in support of regulatory approval and marketing needs.
Utilize technical clinical affairs skills to propose strategies on complex issues.
Provide clinical input to product lifecycle planning.
Provide strategic input and technical guidance on clinical requirements to development teams.
Manage and execute pre-approval clinical activities.
Monitor impact of changing regulations on submission strategies and update internal stakeholders.
Support and review regulatory submissions as required.
Contribute to applicable submissions (IDE, PMA, CER, etc.), reports and responses to regulatory authorities.
Ensure compliance with product post-marketing approval requirements.
Establish and maintain relationships with alliance partners, external companies, investigators and key opinion leaders to optimize performance on clinical trial activities.
Review and approve required reports, supplemental submissions and other post-marketing commitments to update and maintain product approvals and registrations.
Provide training for stakeholders on current and new clinical requirements to ensure company-wide compliance.
Develop and maintain ClinicalTrials.gov responsibilities for the business unit products.
Develop and maintain business unit SOPs/processes for clinical research.
Interface with Corporate Medical Affairs on developing processes and internal standards.
Minimum M.S. Science, engineering, or other relevant technical degree with minimum 10 years of leadership experience in clinical affairs. Advanced degree (e.g. MPH, PhD) strongly preferred.
Broad knowledge and experience with clinical affairs regulations and implementation.
Demonstrated track record of managing multiple parallel studies from initiation through completion with resulting successful marketing authorization, publications, and establishment of broadened indications and claims for medical devices.
Thorough knowledge of medical products quality system principles and GCP concepts, practices and procedures.
For more information on this role including the generous compensation and bonus scheme associated please CLICK APPLY forward an up to date resume.