Senior Director Clinical Operations

Senior Director, Clinical Operations

$250,000-$275,000

USA (Remote)

Job Description

EPM is partnered with a cutting-edge biotech firm at the forefront of revolutionizing targeted oncology therapies. Leveraging groundbreaking advancements in the human immune system, their proprietary therapies target the root causes of what causes ineffective treatments, and uses those to change the way they treat patients. They are dedicated to transforming lives by developing innovative solutions that not only give their trials a higher chance of success, but have the potential to alter the way oncology therapies are created. With a commitment to scientific excellence, the team is poised to redefine the landscape of oncology healthcare, offering hope and relief to millions worldwide.

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 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