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
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