Associate Director, Clinical Operations
New
4
4D Molecular TherapeuticsBiotechnology
Remote, United StatesFull-TimeManager
Salary179,000 - 196,000 USD per year
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Job Details
- Experience
- B.S./B.A. with 9+ years of industry experience in clinical development; M.A./M.S. with 4+ years of experience.
- Required Skills
- GCPBudget management
Requirements
- B.S./B.A. in Life Science or related discipline required; Advanced degree (M.S./M.A., MPH, MHS, MBA) preferred.
- 9+ years of industry experience in clinical development with at least 3 years of managerial experience (or 4+ years with an M.A./M.S.).
- Proven experience in late-phase clinical trial execution.
- Thorough knowledge of FDA and ICH Guidelines, GCP, and medical terminology.
- Ability to manage functional and clinical trial-specific budgets.
- Proven ability to recruit, retain, and motivate clinical operations personnel.
- Strong interpersonal skills to partner with various functional groups.
- Excellent communication skills with the ability to present complex information clearly.
- Ability to prioritize and manage a large volume of work with attention to detail.
- Clinical Research certification is preferred but not required.
Responsibilities
- Partner with Director of Clinical Operations to manage clinical programs and ensure corporate objectives are met.
- Provide operational leadership for trial planning, execution, and data collection, including monitoring timelines and risks.
- Mentor Clinical Trial Managers and junior staff on study documents, vendor management, and issue resolution.
- Oversee day-to-day operations of Clinical Trial Operations and Clinical Data Management groups.
- Manage external budgets, vendor outsourcing strategies, and vendor governance committees.
- Ensure clinical trials are inspection ready and managed by a cross-functional Study Execution Team (SET).
- Collaborate with Regulatory Affairs and Clinical Sciences on regulatory submissions and compliance.
- Coordinate the development and maintenance of clinical SOPs and trial-specific documents.
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