Director / Senior Director Clinical Operations Oncology

Job Title: Director/Senior Director, Clinical Operations

Location: Cambridge, MA (Hybrid – ~3 days onsite per week)

About the Company:

Our client is an innovative and fast-growing small biotech organization focused on transforming oncology treatment, with a strong emphasis on solid tumors. As it expands its operations in the U.S., our client is seeking a dynamic and experienced Director/Senior Director of Clinical Operations to build and lead its first U.S. office.

Position Overview:

This is a unique opportunity for an experienced Clinical Operations leader to help establish and scale our client’s clinical development activities in the U.S. The individual in this role will be responsible for building the operational foundation of the U.S. team, ensuring the successful execution of clinical trials from Phase I to III in oncology. As the first U.S. hire, this individual will play a pivotal role in shaping the future of the company’s U.S. operations while reporting directly to the SVP of Clinical Operations.

Key Responsibilities:

• Establish U.S. Clinical Operations Office: Lead the setup and build-out of the company’s first U.S. office, ensuring smooth integration into the company’s global operations.
• Clinical Trial Execution: Oversee the operational aspects of clinical trials in oncology (solid tumors), including trial initiation, execution, and close-out for Phase I-III studies.
• Team Leadership: Manage and mentor the growing U.S. clinical operations team, establishing roles and responsibilities as the team expands.
• Cross-Functional Collaboration: Work closely with global teams (especially in Europe) to ensure alignment on clinical development strategies and timelines.
• Stakeholder Communication: Serve as a key point of contact for senior management and cross-functional teams, ensuring transparent communication and regular updates on trial progress and challenges.
• Global Experience: Collaborate effectively in a global setting, navigating cultural and operational differences, while aligning with global clinical trial strategies.
• Regulatory & Compliance Oversight: Ensure all clinical operations are conducted in compliance with applicable regulatory standards, company policies, and best practices.
• Continuous Improvement: Contribute to the continuous improvement of clinical operations processes and procedures, leveraging your experience and insights to optimize efficiency and quality.

Qualifications:

• Experience:
• 5+ years of managerial experience in clinical operations, with at least 3 years in a leadership role at a small to mid-sized biotech company.
• Extensive experience in oncology clinical trials, particularly in solid tumors (Phase I-III).
• Strong entrepreneurial mindset with a proven ability to navigate a startup-like environment and handle trial and error as part of scaling operations.

• Skills:
• Exceptional communication and interpersonal skills, with experience working in global and cross-functional teams.
• Ability to thrive in an ambiguous, fast-paced environment, and demonstrate problem-solving skills.
• Experience in building and scaling clinical operations teams and offices in new regions.
• Knowledge of clinical trial management, regulatory requirements, and industry best practices.
• Education: Advanced degree (MD, PhD, or equivalent) preferred, but not required.  
  Additional Notes:
  • Flexibility in the office location and working schedule (hybrid model), with expected on-site presence of ~3 days per week in Cambridge.
  • Ability to collaborate effectively with leadership and teams across multiple time zones, particularly in Europe.
   
  
  Benefits: The role offers a competitive compensation package with opportunities for growth as the U.S. office scales. Benefits setup will be part of this role’s responsibility, so candidates should be comfortable with establishing and refining such frameworks in collaboration with global HR.