Director Clinical Operations

A growing biotechnology company based in Waltham, Massachusetts is looking for an Director, Clinical Operations to join the team!

This is an opportunity to join a close-knit biotechnology company in the Oncology space. You will be offered the flexibility for hybrid working and a generous compensation package, including unlimited PTO, healthcare, 401k with 3% match and wellness benefits.

Role and responsibilities

The Director will be responsible for leading global clinical trials in Phases I – III in collaboration with the Head of Clinical Operations. You will ensure the successful execution of studies according to regulatory guidelines, timelines and budgets.

Additional responsibilities include:

• Create and execute clinical operations and study-specific strategies in line with the clinical development plan.
• Work closely with cross-functional stakeholders and external vendors to manage, supervise, and ensure the successful execution of clinical trials.
• Oversee the overall management and maintenance of budgets, resources, and timelines for assigned studies.
• Proactively identify risks, develop mitigation plans, address issues, and implement contingency strategies.

Key requirements

• Bachelor’s degree; advanced degree preferred
• 10 years of clinical operations experience, including 5 years in a management capacity
• Start-up biotech experience preferred
• Knowledge of GCP guidelines and applicable FDA regulations
• Experience with oncology clinical trials
• Strong leadership and people management skills

If you are interested in discussing further, please apply directly or reach out for further information.