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
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