Senior Director Clinical Operations
Remote (USA)
$250,000 - $270,000
Job Description
EPM is partnered with a cutting-edge biotech that is dedicated to pioneering breakthrough therapies for diverse and traditionally unmet medical needs related to liver diseases. Their mission? To revolutionize healthcare and the way that patients are treated across the globe. With a diverse pipeline of various clinical stage assets across a number of therapeutic areas, the potential regarding their drug platform is unlimited. By harnessing the power of data driven drug development, they are able to precisely and efficiently create new treatments that are not only cheaper, but more effective as well.
Key Qualifications
- Bachelor's degree in a life science related field
- 12+ years of managing clinical trials at a Biotech or Pharmaceutical company (not CRO)
- Experience working on GI, Liver Diseases, Hepatology, or Oncology strongly desired
- Extensive experience overseeing and managing CROs
- Global trial management and oversight experience
- Late phase trial management experience required
- Excellent verbal and written communication skills, with the ability to effetively communicate with internal teams, external stakeholders, and study sites.
- Strong understanding of regulatory requirements governing clinical trials, including FDA regulations, ICH-GCP guidelines, and other relevant standards
Roles and Responsibilities
- Lead and motivate cross-functional teams, including clinical research associates, data managers, and other stakeholders, to ensure effective collaboration and achievement of study goals
- Identify and mitigate risks throughout the trial lifecycle, proactively addressing issues that may impact study timelines, quality, or compliance.
- Oversee the development of Clinical Trial protocols, ensuring they adhere to regulatory standards and meet scientific objectives
- Coordinate all aspects of clinical trial operations, including timelines, budgets, and resources allocation
- Oversee site selection, initiation, and ongoing monitoring activities to ensure sites are conducting trials according to protocol and in compliance with GCP standards
Benefits
- Medical
- Dental
- 401(k)
- PTO
