Director Clinical Operations
New York City, New York (hybrid)
$175,000 - $200,000
My client is a focused and growing company, dedicated to developing innovative therapies for neuropsychiatric diseases and improving outcomes for patients. They are building a pipeline that leverages the broad therapeutic potential of its lead product candidate for the treatment of schizophrenia and other neuropsychiatric diseases. With tried and true leadership and very positive data, it's an exciting time to get a foot in the door with them.
Responsibilities
- Accountability for the overall management of assigned clinical programs (across multiple studies), including providing strategic direction to study teams to ensure timely clinical trial execution.
- Maintaining inspection-readiness across clinical programs.
- Assistance in development of hiring/resourcing plans and program budgets.
- Assist in the hiring process to build out the study team.
- Day-to-day management of assigned direct reports.
- Mentorship and oversight of junior team members.
- Oversight of clinical research organizations (CROs) and other key vendors to ensure timely and quality deliverables.
- Act as a point of escalation for clinical trial execution issues.
- Lead preparation of vendor requirements and project scope and selection of study vendors.
- Contribution to the establishment of KPIs to measure vendor performance.
- Implementation of appropriate systems, standards, and processes to ensure quality at the level of investigative sites, vendors, and data.
- Oversight of the clinical aspects of timely data cleaning, data analysis and the availability of top line results.
- Oversight of the set-up and implementation of effective investigator and site monitor training; facilitation of operational and therapeutic area training for internal and external study team members.
- Review of study invoices and participation in accrual reviews to track the financial status of the study against budget.
- Establishment of clinical operations SOPs, Work Instructions, guidelines, standards, and best practices.
- Leadership and implementation of infrastructure initiatives, process improvements, change management, and ad-hoc business projects.
- Demonstrated understanding of the clinical program oversight, including monitoring of data, review of TLF, implementation and working of IRT, EDC development, vendor oversight.
Qualifications
- Bachelors degree required and Masters degree preferred.
- Some prior experience in a medical field, such as nursing or pharmacy.
- 12+ years of experience working with CROs to manage large global clinical trials. CNS disease experience is a plus.
- 4+ years of experienced in managing direct reports, evidencing strong leadership, team-building, and hands-on management.
- Experience monitoring all types of data
- Comprehensive understanding of ICH and GCP guidelines, as well as applicable regulations and practices.
- Excellent organizational skills and attention to detail.
- Effective communication and interpersonal skills.
- Able to set priorities, juggle multiple demands, and manage changing priorities.
- Able to think critically and be a proactive problem-solver.
- Able to work independently while exercising initiative, flexibility, and sound judgment.
- Comfortable working with different levels of the company including senior level management.
- Ability to travel approximately 30%
- Ability to operate in alignment with company values and culture.
Benefits
Company benefits include a comprehensive medical plan, 401K participation, three weeks of vacation, and a steeply discounted Lifetime gym membership. This is a dynamic and supportive work environment offering a competitive benefits package, as well as the opportunity to become a shareholder in the Company and participate in its future success.
