Director Clinical Operations Study Management

Director Clinical Operations

Salary: $225,000 - $245,000

New York City or Jersey City (Hybrid)

Job Description

Founded by a team of noble prize winning scientists, EPM is partnered with one of the most exciting and cutting edge biotech companies in the industry. They have raised over $1 billion dollars of funding to advance their pipeline of 7 programs and are gearing up for their first Phase 3. Focusing in oncology, they are using a first of it's kind drug discovery platform that has allowed them to create the most innovative drugs ever seen.

Responsibilities

• Identify and proactively address potential risks and issues in clinical trials, implementing mitigation plans to ensure trial success
• Provide leadership and mentorship to clinical operations teams, fostering a collaborative and high-performance work environment while managing and developing talent within the department
• Collaborate with cross-functional teams to develop and execute clinical trial strategies aligned with the company's goals and objectives
• Ensure that all clinical operations comply with regulatory requirements and industry standards, maintaining the highest quality standards in study conduct and documentation
• Oversee relationships with vendors, and external partners, ensuring their performance aligns with project objectives and budgets

Qualifications

• 10+ years of hands-on experience in clinical operations within the biotech or pharmaceutical industry, including direct involvement in planning and managing clinical trials
• A deep understanding of oncology clinical trials (8+ years), including knowledge of the unique challenges and considerations associated with these trials, is highly desirable
• At least a bachelor's degree in a relevant life sciences field
• Excellent verbal and written communication skills, including the ability to convey complex scientific and clinical information to both technical and non-technical stakeholders
• Proficiency in regulatory compliance and an in-depth understanding of international regulations and guidelines related to clinical trial conduct

Benefits

• Medical, dental, vision insurance
• 401(k)
• PTO and Holidays