Director of Clinical Operations

The Role

The Vice President of Clinical Operations will be responsible for the leadership, oversight and execution of the company's clinical trials in the Central U.S., ensuring they are completed according to timelines, budgets, and regulatory/corporate quality standards. The Vice President will report to the Chief Executive Officer, and will serve as a functional leader, line manager and subject matter expert for clinical operations. The incumbent will work collaboratively with other senior leaders including business development and strategic partnerships to achieve corporate objectives and initiatives. With extensive industry knowledge and experience, the Vice President will proactively seek to develop strategies necessary for successful physician and clinical onboarding, patient enrollment, data collection, assessment, analysis, and reporting for all sites and studies, as well as to improve the efficiency, effectiveness, and quality of the Company's clinical trial capabilities. The incumbent will ensure all clinical studies are conducted in accordance with company SOPs, GCPs and ICH guidelines.

Job Description/Responsibilities

• Implement and execute the clinical development plan:
  • Develop collaborative alliances and relationships with external service providers, investigators and clinical site staff
  • Identify and manage external contractors and vendors as needed to ensure project objectives are met within required timelines and budget
  • Ensure studies are performed to regulatory standards and all elements are included to meet submission requirements
  • Provide Clinical Operations expertise, leadership, and input to project teams, commercial, regulatory, fundraising, due diligence and other projects that may arise from senior management
  • Develop clinical operations strategy for successful delivery of clinical studies within timelines and budget
  • Strong understanding of core industry technology platforms
  • Manage forecasting, budgets, contract compliance, timelines
  • Ensure scope of contracts addresses all anticipated issues with study conduct and minimizes the need for change orders.
  • Ensure collected data are complete, reviewed, and issues are appropriately resolved, on an ongoing basis
  • Ensure SOPs, manuals or checklists (working document) are implemented in order to facilitate tasks efficiently
  • Contribute to development/maintenance of SOPS, as subject matter expert, including clinical and vendor management related SOPs
  • Prepare/review and/or manage clinical trial agreements, informed consent forms, case report forms, study procedures manuals, clinical study reports and other clinical documents as necessary
  • Ensure development, review and execution of activities outlined in various study plans, e.g., data management plan, safety management plan, sample management plan, CRF completion guidelines, eCRFs, IWRS system specifications, and clinical supply/packaging/distribution plans
  • Assure compliance of monitors, consultants, investigators, and vendors with study procedures/manuals, GCP, SOPs and guidelines
  • Lead meetings for internal clinical team members, CROs, vendors and partners, as needed
  • Manage investigator meetings
  • Hire, train and supervise clinical site employees; foster the growth and development and provide mentorship for the clinical development team
  • Oversee performance management and career development for direct reports
  • Perform other duties as required and assumes other responsibilities as assigned by the CEO

Minimum Requirements

• Advanced degree with science/life science concentration or commensurate experience
• Five years of clinical experience, including successful execution of multi-site clinical trials
• Knowledge of regulations relating to clinical drug development, especially GCP
• In addition, must possess:
  • Strong organizational and management skills
  • Ability to manage multiple priorities and establish and meet deadlines.
  • Excellent interpersonal skills
  • Ability to ensure details are consistently accurate
  • Ability to mentor and collaborate with others and work effectively
  • Ability to thrive in a fast-paced environment and adapt to rapidly evolving needs
  • Proficient with Microsoft Word, PowerPoint, Excel, Teams and web-based systems.
  • Ability to travel +/-10% of time
  • Flexible work environment: Hybrid model encompassing both in-person office participation at our Corporate Research site and the ability to work remotely

Preferred Skills/Experience

• Knowledge of variety of clinical trials and therapeutic areas
• Knowledge of GDPR requirements and other data privacy requirements
• Experience with multicenter trials

Anticipated Start Date: Immediately

What We Offer:

• A competitive salary $115,000 - $132,000 commensurate with experience and able to earn additional bonus compensation.
• Ability to make a meaningful impact in the lives of our patients
• Exceptional opportunities for learning and growth
• Company-paid holidays
• Paid time off
• Health and dental insurance as it becomes available
• Disability as it becomes available
• Life insurance401(k) plan + match as it becomes available

Axsendo Clinical Research is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity or any other protected class.

To all agencies: Please, no phone calls or emails to any employee of Axsendo Clinical Research about this requisition. All resumes submitted by search firms/employment agencies to any employee at Axsendo Clinical Research via-email, the internet or in any form and/or method will be deemed the sole property of Axsendo Clinical Research, unless such search firms/employment agencies were engaged by Axsendo Clinical Research for this requisition and a valid agreement with Axsendo Clinical Research is in place. In the event a candidate who was submitted outside of the Axsendo Clinical Research agency engagement process is hired, no fee or payment of any kind will be paid.