Director, Clinical Research & Regulatory Affairs
Ladders · New York, NY · Yesterday
On-siteAnalyst$230k–$245k/yrFull-time
Responsibilities
- Lead company-sponsored clinical studies in compliance with Good Clinical Practice (GCP)
- Design clinical study protocols and statistical plans with cross-functional teams
- Review and analyze clinical data to support product performance
- Develop and implement Standard Operating Procedures (SOPs) for clinical trials
- Manage all aspects of the Investigator Initiated Trials (IIT) program
- Recruit clinicians and research partners for clinical studies
- Manage and mentor clinical team members while identifying staffing and budget needs
Qualifications
- BS in Engineering or a Technical Field; advanced degree (PhD, MD, or equivalent) preferred
- 7-10 years in medical device or healthcare industry, with 6 years in clinical affairs or trial management
- Established network of KOLs and clinical research collaborators
- Strong knowledge of GCP, IRB/Ethics Committee requirements, and clinical study design
- Experience writing SOPs and clinical research documentation
- Excellent communication, leadership, and cross-functional collaboration skills
Pay
$230,000 – $245,000 annually
Schedule
US based candidates only, no visa sponsorship available
Benefits
- Comprehensive health insurance, including dental and vision coverage
- Employee Assistance Program for emotional and day-to-day support
- 401k plan with matching contributions
- Opportunity to participate in Employee Stock Purchase Plan (ESPP)
- Unlimited Paid Time Off plus 10 Holiday Days per year
- Parental Leave for bonding with family members
- Equity opportunities to encourage employee investment in the company
Skills
Not specified
Benefits
- Opportunity to contribute to a revolutionary healthcare product
Company Information
Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.