What are the responsibilities and job description for the Director / Senior Director Clinical Operations Oncology position at People With Chemistry?
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 :
Additional Notes :
Flexibility in the office location and working schedule (hybrid model), with expected on-site presence of ~3 days per week in Cambridge.
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.
