- Manage and direct clinical trial team and work distribution
- Key contributor and overseer of inter-departmental interactions
- Lead full life cycle of study design, approval, and conduct by translating strategic decisions into operational implementation
- Key contributor to the development of strategic plans for all clinical trials and Clinical Operations activities
- Provide broad contribution at the strategic level including input into project planning and risk management plans to ensure trials are properly defined, planned, and executed across all clinical stage programs
- Create clinical trial plans, procedures, and documents
- Responsible for assisting with creation of clinical trial protocols and ICFs
- Oversee multiple studies, cross functional projects, and departmental initiatives
- Help to develop standard practices and training guidelines within the department
- Proactively collaborate with cross functional departments to meet company objectives on time and in budget
- Identify risks to study timelines and conduct, propose mitigations and implement solutions with team and management support
- Ensure corporate goals are effectively communicated and operationalized within the internal and external study teams
- Participate in cross functional study meetings, Investigator Meetings, scientific conferences and 1:1 outreach to investigators
- Monitor study quality metrics, identify areas for improvement and work with the team to put action plans in place
- Work closely with the Chief Medical Officer, Director of Clinical Operations as well as the project Data Manager and Medical Monitor(s) during the conduct of clinical trials
- Conduct or lead study visits that can include site qualification, site initiation, interim monitoring, sponsor audits, and compliance
- Point of escalation and/or primary study conduct
- Ensure compliance with protocol, overall clinical objectives, and regulatory requirements
- Contributes to global regulatory submissions
- Provide oversight and mentorship to Director of Clinical Operations, Clinical Trial Managers, Clinical Research Associates, Clinical Trial Associates, and Clinical Interns by providing clinical operations and functional area expertise
- Strive for continuous improvement and more efficient ways of working in clinical development
- Complete other responsibilities as needed and agreed upon
- Previous team management experience
- 15 plus years in clinical trial management with majority of time at a sponsor company strongly preferred
- 5 plus years experience with dermatology clinical trials and topical drug development
- Experience in leading all aspects of clinical trials, including initiation, conduct and execution, completion and close-out
- Bachelor's degree or equivalent training and experience
- Experience leading clinical studies in a fast-paced environment
- Experience with both domestic and international clinical trials preferred
- Experience with research protocols and regulatory or governing bodies, which include HIPAA, and FDA regulations, Institutional Review Board requirements and Good Clinical Practices
- Success at a start-up biotech company desired
- Excellent clinical technical writing skills
- Excellent communication skills and ability to achieve milestones in a team environment
- Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team
- Success in vendor management
- Resilient, creative, capable problem-solver
- Excellent organizational skills and ability to work independently
- Travel: Some to considerable national and international travel will be required
- Willing and able to be located or relocated to Emeryville, CA.
- This is an in-person position.
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Vice President of Clinical Operations - Emeryville, United States - DermBiont, Inc.
2 weeks ago
Description
Organization:DermBiont's mission is to become the world's leading precision dermatology company developing targeted topical therapeutics that treat, cure, and prevent diseases. The company aims to impact the root cause of skin diseases with biotherapeutics that repair an imbalance of the microbiome as well as through the development of targeted small molecule therapeutics with well-defined mechanisms of action.
Position Summary:
Reporting to the Chief Medical Officer, the Vice President of Clinical Operations will be in charge of leading multiple studies through collaborative leadership within the Clinical Operations and cross-functional teams. The Vice President of Clinical Operations will have direct line management of Clinical Operations, and will also work closely with Investigators, contract CRAs, and vendor partners.
The ideal candidate will have experience leading multiple studies within a clinical program without a CRO component, and direct line management experience. This leadership position will require close collaboration across the organization. Critical to success will be your willingness to work directly on project tasks.
Responsibilities:
