Director of Clinical Operations and Data Management (Early Development)
Job description
Scorpion Therapeutics is a precision oncology company founded in February 2020 by a preeminent group of scientists from Harvard University/Massachusetts General Hospital – Keith Flaherty, MD, Gaddy Getz, Ph.D. and Liron Bar-Peled, Ph.D. The company has raised $270M in Series A and Series B financings led by blue-chip investors, including Atlas Venture, Boxer Capital of Tavistock Group, EcoR1 Capital, LLC, Omega Funds, and Vida Venture.
Scorpion Therapeutics' mission is to serve oncology patients by discovering and developing best-in-class and first-in-class, small molecule cancer medicines that address large patient segments with significant unmet medical needs. To accomplish this mission, we are building a highly collaborative team focused on the pursuit of novel approaches to small molecule drug discovery. This approach relies upon dynamic collaboration between cancer biology, proteomics, informatics, structural biology and medicinal chemistry – with the ultimate goal of realizing the full potential of targeted/precision oncology.
Job Summary:
In this newly created role, this individual will manage oncology clinical trials under the leadership of the COO.. This leader will be responsible for helping to build the clinical organization and develop close collaboration with CROs, 3rd party vendors and clinical sites. The candidate will manage and oversee global, early phase clinical trials though the development of novel drugs.
Job Responsibilities:
- Responsible and accountable for the operational strategy and overall execution of clinical programs
- Manage clinical trials from start-up through close-out to ensure that both internal and external deliverables are on time and on budget
- Oversee the development of clinical trial project timelines and ensure communication and understanding of risks and challenges; establish plans and monitor metrics; ensure that timelines are accurate and comprehensive.
- Work cross-functionally to coordinate the relevant and timely exchange of information and materials to support clinical trial delivery.
- Manage CRO services including, clinical operations, data management, IVRS, central laboratories and imaging, clinical supply vendors, etc.
- Identify clinical study challenges and risks, proactively developing mitigation plans to ensure trial deliverables and performance goals are met.
- Prepare/review and manage all study, site and patient related documents
- Oversees the global site identification and selection process, building relationships with sites to make certain recruitment timelines can be achieved
- Develop and manage the study and site budget, and ensures budgets are in line with approved budget
- Proactively manage project scope and change orders for clinical trials
- Manage direct and indirect reports, providing training and coaching of team members
- Ensures all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs
Skills & Qualifications:
- Bachelor's Degree in a life science or allied health field (e.g. Nursing, Medical or Laboratory Technology) is required
- Minimum of 8 years of experience in clinical trial operations is required
- Minimum of 4 years of oncology experience is required
- Biotechnology experience is a plus
- Early phase experience, including IND submissions, is required
- Extensive vendor management and project management skills are critical
- Excellent written and oral communication skills
- Strong problem solving skills. Able to quickly identify problems, analyze the issue and rapidly develops a solution
- Strong working knowledge of GCP/ICH and other applicable regulations/guidelines is required
- Good organizational/prioritization skills with strong attention to detail and an eye for quality
- Strong proficiency with MS Office programs such as Outlook, Word, Excel, PowerPoint, and SharePoint is required
- A collaborative spirit for working successfully with cross-functional teams and partners is essential
Scorpion Therapeutics Inc. is an Equal Opportunity Employer who strives to create and maintain a diverse working environment. We do not discriminate for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Beginning October 13, 2021, Scorpion Therapeutics requires all new hires to be fully vaccinated against COVID-19. If you are unable to receive the vaccine due to a disability or serious medical condition, or because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.
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