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Vice President of Clinical Operations - Emeryville, United States - DermBiont, Inc.
4 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.
Responsibilities:
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
Qualifications:
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.
DermBiont is an equal opportunity employer.
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