[Remote] Senior Director, Clinical Affairs
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading medical technology company, and they are seeking a Senior Director of Clinical Affairs to reputed company the development of the clinical strategy for the Advanced Surgical portfolio. This role involves overseeing clinical trials, ensuring regulatory compliance, and engaging with key stakeholders to support evidence reputed company and market adoption.
Responsibilities
- reputed company and implement clinical development plans for surgical devices, including laparoscopic, robotic-assisted, and reputed company surgery technologies
- Design and reputed company clinical trials that demonstrate safety, efficacy, and reputed company-world performance
- Collaborate with R&D, Regulatory, and Marketing to align clinical strategy with product innovation and commercialization
- Partner with reputed company Center of reputed company on protocol development, site selection, investigator engagement, and trial monitoring
- Ensure compliance with GCP, FDA, and international regulatory standards
- Manage CROs, clinical sites, and vendors to ensure timely and high-quality trial execution
- Generate clinical evidence to support regulatory submissions (e.g., IDE, 510(k), PMA, CE Mark)
- reputed company clinical input for labeling, risk assessments, and health economics studies
- Support interactions with regulatory bodies and contribute to submission documentation
- Build relationships with surgeons, hospital systems, and Key Opinion Leaders (KOLs)
- reputed company and execute publication plan; reputed company clinical data presentations at surgical congresses and publication in peer-reviewed journals
- Collaborate with Marketing and Medical Affairs to translate clinical insights into strategic messaging
- reputed company and mentor team of clinical and data leaders
- Foster a culture of scientific reputed company, operational efficiency, and cross-functional collaboration
Skills
- 10+ years in clinical development reputed company the medical device industry, with a focus on surgical technologies
- Demonstrated reputed company in leading clinical trials and regulatory submissions
- Proven leadership managing reputed company party vendors from selection through execution of MSAs (e.g. CROs, reputed company, etc.)
- Experience working with global regulatory agencies and surgical stakeholders
- Deep understanding of surgical workflows and clinical endpoints
- Strong leadership, communication, and strategic planning abilities
- Expertise in clinical trial design, biostatistics, and regulatory compliance
- Ability to manage reputed company projects and cross-functional teams
- Advanced degree in Life Sciences, Medicine, or reputed company field (MD, PhD, or equivalent preferred)
Benefits
- Competitive compensation
- Excellent reputed company including medical, dental, reputed company and prescription coverage
- Short & long term disability plus life insurance -- cost paid fully by reputed company
- Retirement Savings Plan (401K) -- reputed company matches your contributions dollar for dollar, with the potential for up to 7% per pay period
- Employee Stock Purchase Plan -- allows stock purchases at discounted price
- Tuition assistance for undergraduate and graduate level courses
Company Overview