Title: Associate Director, Clinical Operations - Rare Disease/Oncology Background Needed

Location: Waltham, MA (Onsite 2 Days Weekly)

Key Responsibilities:

• Lead and oversee the execution of clinical trials within the rare disease and oncology therapeutic areas.
• Develop and implement strategic plans for clinical trial operations to ensure timely and successful completion of studies.
• Provide guidance and mentorship to clinical operations team members, fostering their professional growth and development.
• Collaborate cross-functionally with internal teams, including clinical development, regulatory affairs, medical affairs, and project management.
• Manage relationships with external vendors and clinical research organizations (CROs) to ensure quality and compliance throughout the trial process.
• Contribute to the development and implementation of standard operating procedures (SOPs) and best practices in clinical operations.

Requirements:

• Bachelor's degree in a scientific or healthcare-related field; advanced degree (e.g., Master's, PhD) preferred.
• Minimum of 5 years of trial management experience in clinical operations within the pharmaceutical or biotechnology industry, with a focus on rare diseases and/or oncology.
• Strong understanding of Good Clinical Practice (GCP) guidelines and regulatory requirements governing clinical trials.
• Proven track record of successfully managing multiple clinical trials simultaneously, from initiation through closeout.
• Excellent leadership and communication skills, with the ability to effectively collaborate with cross-functional teams and external partners.
• Experience managing onsite/offsite clinical operations teams is preferred.