Patients First. Powered by Evidence.
Director, Clinical Research – REMS
Location
United States
Posted
1 day ago
Salary
Not specified
Seniority
Lead
Job Description
Job Requirements
- Advanced Degree preferred, bachelor’s degree or equivalent experience required
- Extensive project management experience at a CRO or proven leadership/management experience managing multiple projects and project teams (additional or other relevant management experience may be considered)
- Strong knowledge of FDA/ICH regulatory guidelines; only applicable for Europe if required
- Working knowledge of functional components of clinical drug development (e.g., clinical, data management, statistics and regulatory/medical writing)
- Mastery of project management skills with the ability to lead through change and independently lead multiple large projects simultaneously
- Solid problem-solving and analytical skills with willingness and ability to detect process gaps, challenge assumptions, and drive change and improvement
- Ability to work in a team environment under high-pressure situations
- Excellent interpersonal, written, and verbal communication skills
- Proven ability to interpret and prioritize customer needs
- Strong influencing and negotiation skills
- Takes initiative and is results and detail oriented
- Ability to build strong business relationships across various departments
- Broad therapeutic experience a plus
- 10% travel as required
- Extensive knowledge of Clinical Trial Monitoring, as required
- Clinical background or equivalency in clinical research experience, as required
- Proven knowledge of medical terminology
- European/Global experience a plus
- Advanced computer skills
Benefits
- Remote opportunities
- Competitive salaries
- Growth opportunities for promotion
- 401K with company match
- Tuition reimbursement (after 90 days of employment)
- Flexible work environment
- Discretionary PTO (Paid Time Off)
- Paid Holidays
- Employee assistance programs
- Medical, Dental, and vision coverage
- HSA/FSA
- Telemedicine (Virtual doctor appointments)
- Wellness program
- Adoption assistance
- Short-term disability (after 90 days of employment)
- Long-term disability
- Life insurance
- Discount programs
Related Guides
Related Categories
Related Job Pages
More Clinical Research Jobs
The Clinical Research Associate is responsible for the preparation, initiation, monitoring, and closure of assigned clinical study sites, ensuring compliance with guidelines like ICH-GCP and local regulations. This role involves acting as the main contact for study sites, driving performance, resolving issues, managing study supplies, and ensuring data quality through monitoring visits and source data review.
Clinical Trial Manager
4DMT - 4D Molecular Therapeutics4DMT, or 4D Molecular Therapeutics, is a biopharmaceutical company that develops gene therapies for genetic diseases. The company emphasizes innovation, collabo
Clinical Trial Manager supporting biotech trials at 4D Molecular Therapeutics
Clinical Research Manager
Johns Hopkins UniversityDepartment name: IT@JH Networking, Telecom and Data Ctr Personnel area: University Administration
This role involves managing the administrative and scientific implementation of complex clinical protocols across 20+ sites, requiring independent judgment in research conduct and collaboration with investigators and faculty. Key duties include developing protocols and SOPs, ensuring regulatory compliance, managing grant submissions, and supervising research staff.
The Senior Field Clinical Engineer will support all phases of clinical research studies, including site activation, training, and enrollment support, while providing on-site technical assistance during clinical procedures and initial product implants. This role serves as a liaison between engineering, clinical research teams, and physicians to ensure proper device use, protocol adherence, and high-quality data collection.


