Salary: $200,000-$220,000
Director Clinical Operations
Boston, MA (Hybrid)
Job Description
A pioneering Biotech in the heart of Boston, dedicated to revolutionizing autoimmune 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 to restore harmony within the immune system. Their team of top scientists and clinicians is committed to delivering precise, effective solutions for patients battling autoimmune conditions. 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 autoimmune 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
