Associate Director, Clinical Operations

Advanced Clinical; Cambridge (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

A leading company in Cambridge is seeking an Associate Director of Clinical Operations to manage clinical trials and ensure compliance with regulations. This role involves overseeing budgets, collaborating with teams, and mentoring staff to drive innovative treatments for rare diseases.

Qualifications

• 8-10 years of relevant Clinical Operations experience in biotech/pharma.
• Experience with NDA/BLA submissions and FDA regulations.

Responsibilities

• Manage and execute high-quality clinical trials on time and within budget.
• Oversee study planning, management, and oversight.
• Collaborate with cross-functional teams and external vendors.

Skills

Project Management

Regulatory Compliance

Cross-Functional Collaboration

Education

Bachelor’s degree

Advanced degree

Job description

Join to apply for the Associate Director, Clinical Operations role at Advanced Clinical.

Reporting to: Senior Director, Clinical Operations.

Do you have the passion and commitment to join a group whose mission is to develop treatments that have a clear and profound impact on patients suffering from rare diseases? If yes, we encourage you to share your aspirations and career goals with us.

Our company focuses on restoring healthy immune system function by developing novel therapeutics for chronic neutropenic disorders, including WHIM syndrome, a rare primary immunodeficiency. We are advancing a late-stage clinical candidate, mavorixafor, which has the potential to become a new standard of care. We value innovative science and a collaborative environment where our mission drives our actions.

Accountabilities and Responsibilities

• Manage and execute high-quality clinical trials on time and within budget.
• Oversee study planning, management, and oversight, including monitoring progress, data quality, and vendor performance.
• Identify risks, develop mitigation strategies, and escalate issues as needed.
• Manage study budgets, negotiate contracts, and ensure proper payments.
• Collaborate with cross-functional teams and external vendors, ensuring compliance with regulations and ethical guidelines.
• Support regulatory submissions and queries.
• Lead protocol and document development, and foster strong relationships with investigators and vendors.
• Maintain communication with site staff and investigators to ensure optimal study conduct.
• Lead planning of investigator meetings and site training.
• Contribute to best practices and SOP development.
• May mentor other Clinical Operations staff.

Requirements: Proven Experience, Skills, and Education

• Bachelor’s degree required; advanced degree preferred.
• 8-10 years of relevant Clinical Operations experience in biotech/pharma.
• Experience with NDA/BLA submissions, FDA regulations, and international agencies.
• Proven management skills with CROs, vendors, and complex studies.
• Strong cross-functional representation skills.
• Understanding of budget development and management.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Research, Analysis, IT