Director, Clinical Trials

Our client is a global leader in molecular diagnostics and technology. They deliver extensive medical testing expertise, working with state-of-the-art technology and practices to deliver clients accurate and fast results. They are looking to hire a Director, Clinical Trials, to oversee large scale clinical trials and lead strategy through FDA submission.

The Director of Clinical Trials will be responsible for strategy, operation, quality, and execution of clinical trials. In collaboration with the senior management team, this person will develop and implement the strategic goals for project scope including budgets, risk, scheduling, resources, and more.

This Role Offers:

Competitive base salary and comprehensive benefits package. Highly respected industry reputation based on innovative products and technologies. Close-knit environment with likeminded self-starters. Work alongside a team of strong technical professionals offering services to truly impact and support those making advancements within the field of medicine. Culture of integrity, high performance, and quality customer care. Team of capable, experienced, and seasoned professionals at the top of their industry; very high average employee tenure.

Focus:

Establish and expand upon existing departmental goals and procedures within clinical trials and FDA regulations. Oversee monthly departmental, operational, and clinical data. Direct the execution of real-world studies and maintain best practices for related materials. Ensure compliance and regulations related to FDA submission. Plan overall strategy and ensure proper execution of all clinical trials across departments. Implement new programs, tests, methods, and procedures by investigating alternatives; preparing proposals; developing and performing parallel testing; monitoring progress. Maintain quality and accurate medical records by following company procedures. Create reports and deliver key findings to upper management. Stay up to date on and review coding updates, documentation changes, FDA regulations, and specific guideline additions regarding SOPs and GCPs.

Skill Set:

3-5+ years of clinical trial management experience with a background in molecular biology. Start-up experience preferred, ability to build from the ground up. Bachelor’s degree in related field. Advanced degree a plus. Proven ability to grow and lead a team and put trial standards and procedures in place. In-depth experience in science, infectious disease, and microbiology. Broad knowledge of clinical trial procedures and monitoring research on a large scale. Ability to develop protocols with the flexibility to manage multiple projects at a time. Must have proven leadership skills and problem-solving skills including the ability to influence, motivate, and direct others. Proven experience training/overseeing compliance procedures. Firm knowledge of SOP and FDA regulations. Skilled in MS Office Suite and relevant PM software. Exceptional written and oral communication skills, including delivering presentations and medical reporting.