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Sr. Director/Director of Clinical Operations
|Location||San Diego, CA|
|How to Apply|
Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, Adagene’s highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science.
Adagene Inc. is looking for an energetic and talented individual to join its multidisciplinary research and development team.
The Senior Director (SD), Clinical Operations is responsible for leading the strategic planning, oversight and execution of assigned clinical trials across programs. This employee will make or recommend operational strategies and/or decisions in support of achieving clinical program objectives.
The SD of Clinical Operations may also directly manage studies. Responsibilities include creating timelines and budgets, overseeing day-to-day operations, ensuring studies are conducted in accordance with regulatory requirements and within established timelines and budgets. Additionally, the SD of Clinical Operations will be responsible for managing relationships with investigator sites, vendors and consultants.
This position also provides an opportunity to join a growing development organization and contribute substantially to how the company will operationalize oncology trials in the future, while expanding internationally.
The candidate must have the ability to work independently, be an effective leader, and an engaged team member in a dynamic, fast-paced environment.
• Provides leadership and therapeutic expertise for the successful operational management of international clinical trials and contributes to the strategic implementation of a clinical development program(s)
• Lead sponsor study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets.
• Ensure effective project plans are in place and operational for each trial and proactively manage project level operational aspects of Clinical Trial Team including management of trial timeline, budget, quality, resources, vendors and risk mitigation.
• Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team
• Oversees and support Clinical Trial Manager(s) in the conduct of the trials, manages responsible study(ies) within agreed timelines and budget and in accordance with internal SOP’s and GCPs
• Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures.
• Participates in the preparation, review and finalization of clinical study-related documents such as protocols, protocol amendments, Clinical Study Reports (CSRs), regulatory submissions, and other publications as required.
• Effectively solves problems and uses judgment relating to national and international regulations, guidelines, investigator interactions and timelines
• Recruits, hires, mentors and manages CTM/CPM direct reports and supports their professional development
Degree: Bachelor is required, a master, MBA, MPH or similar is strongly preferred.
Major: Clinical Medicine or health related field is required.
Knowledge and Skills:
Equal Opportunity Employer