Director/Sr. Director Clinical Operations

Salary: $200,000 - $275,000

Director/Sr. Director Clinical Operations

New York City (Hybrid)

Job Description

EPM Scientific is partnered with a growing company dedicated to creating innovative treatments for neuropsychiatric diseases. They are building a pipeline that is unlike other drugs currently on the market for their disease areas, and represents a potential life changing possibility for patients. Fresh off of some excitign funding news, and moving into Phase 3, it's an exciting time to join this growing Biotech as they have tried and true leadership to propel their assets to the market.

Roles and Responsibilities

• Responsibility for the overall management of assigned clinical programs across multiple studies
• Providing strategic direction to study teams to ensure timely execution of clinical trials
• Have a key role in hiring/resourcing plans, program budgets, hiring process of study team
• Responsible for day-to-day management of assigned direct reports
• Oversight of CRO and other key vendors to ensure timely and quality deliverables
• Act as point of escalation for clinical trial execution issues
• Oversight of the set-up and implementation of effective investigator and site monitor training
• Leadership and implementation of infrastructure initiatives, process improvements, change management, and business projects
• Oversight of the clinical aspects of timely dat cleaning, data analysis, and the availability of top line resutls

Qualifications

• Bachelor's degree required
• 12+ years of experience working with CROs to manage large scale global clinical trials
• CNS experience is a huge plus
• 4+ years of experience managing direct reports, displaying strong leadership, team building, and hands-on management
• Comprehensive understanding of ICH and GCP guidelines, as well as applicable regulations and practices
• Effective communication and interpersonal skills
• Excellent organizational skills and attention to detail
• Able to work independently while exercising initiative, flexibility, and sound judgement
• Experience monitoring all types of data

Benefits

• 401k
• Equity
• Annual target bonus
• Medical