Location: Boston, Massachussets

Department: Clinical Operations

Reports to: Vice President of Clinical Development

Job Summary: The Director of Clinical Operations will lead and oversee all clinical trial activities for oncology programs. This role is critical in ensuring the successful execution of clinical trials, from early-phase studies through to late-stage development. The Director will work closely with cross-functional teams, including clinical research, regulatory affairs, and data management, to drive the development of innovative cancer therapies.

Key Responsibilities:

• Leadership and Strategy:

  • Develop and implement clinical operations strategies to support the company's oncology pipeline.
  • Provide leadership and direction to the clinical operations team, ensuring alignment with corporate goals and objectives.
  • Oversee the planning, execution, and management of clinical trials, ensuring they are conducted in compliance with regulatory requirements and Good Clinical Practice (GCP).

• Trial Management:

  • Manage all aspects of clinical trials, including site selection, patient recruitment, data collection, and monitoring.
  • Ensure timely and accurate reporting of trial progress and results to senior management and stakeholders.
  • Develop and manage clinical trial budgets, timelines, and resources.

• Vendor and CRO Management:

  • Select and manage Contract Research Organizations (CROs) and other vendors.
  • Monitor vendor performance to ensure quality and compliance with contractual obligations.

• Regulatory Compliance:

  • Ensure all clinical trial activities are conducted in accordance with regulatory requirements and company SOPs.
  • Prepare and submit regulatory documents to ethics committees and regulatory authorities.

• Team Leadership and Development:

  • Lead, mentor, and develop the clinical operations team, fostering a collaborative and high-performance culture.
  • Provide training and support to team members to ensure continuous professional development.

• Cross-Functional Collaboration:

  • Collaborate with cross-functional teams, including clinical research, regulatory affairs, data management, and biostatistics, to ensure the successful execution of clinical trials.
  • Act as a key liaison between the clinical operations team and other departments within the company.

Qualifications:

• Advanced degree in life sciences, nursing, or a related field (PhD, MD, or equivalent preferred).
• Minimum of 10 years of experience in clinical trial management, with at least 5 years in a leadership role.
• Minimum 10 years of oncology therapeutic area and clinical development processes.
• Excellent organizational, communication, and leadership skills.
• Proven ability to manage multiple projects and priorities simultaneously.

Preferred Qualifications:

• Experience in early-phase oncology trials.
• Experience with in-house model.

Benefits:

• Competitive benefits package (401k match, medical health care 100% covered, PTO).
• Pre-IPO equity options.