Director Clinical Operations

Salary: $215,000-$235,000

Director Clinical Operations

Boston, MA (Hybrid)

Job Description

A pioneering Biotech in the heart of Boston, dedicated to revolutionizing a broad scope of rare disease treatment is looking to bring on a Director of Clinical Operations. By leveraging cutting-edge research and breakthrough technologies, they specialize in developing targeted therapies.. Their team of top scientists and clinicians is committed to delivering precise, effective solutions for patients battling a range of genetically rare diseases. Join them in their mission to redefine healthcare and transform lives through innovation and compassion.

Key Qualifications

• Bachelors degree in a Life Sciences related field
• Expansive knowledge of clinical operations, clinical project management related to GCP, ICH, and SOP guidelines
• Ability to work independently as well as collaboratively and has experience working with cross functional stakeholders
• 10+ years overseeing complex clinical trials at a biotech or pharmaceutical company
• Experience working on late phase rare disease indications highly preferred

Roles & Responsibilities

• Develop and implement strategic plans for clinical trials in alignment with the company's overall objectives and regulatory requirements.
• Ensure the effective management of CROs (Contract Research Organizations), vendors, and other external partners involved in clinical trial activities.
• Foster effective communication and collaboration among internal teams and external stakeholders, including investigators, site personnel, and regulatory authorities.
• Represent the company in interactions with regulatory agencies, ensuring clear and timely communication of clinical trial progress and results.
• Establish and maintain high-quality standards for clinical trial conduct in accordance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and internal standard operating procedures.

Benefits

• Medical, dental, vision insurance
• 401(k)
• PTO and Holidays