Director Clinical Operations
Boston, MA (Hybrid)
$210,000 - $230,000
Job Description
A clinical stage biotech in Boston is looking to bring on a Director of Clinical Operations as one of their compounds that just completed IND enabling studies enters Phase 1. With a proven platform (2 drugs on the market), and still tons of opportunity for growth (<150 people), these type of roles do not come around often. The combination of cutting edge technology led by proven leaders in the industry would allow you to learn and develop your career in a short amount of time. Focusing diseases like Alzheimer's, Parkinson's, and Autism, the company is using AI to create some of the most accurate data the industry has seen. Come be a part of the biggest advancements in fighting these conditions, and change the foundation of CNS research.
Key Qualifications
- 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.
- 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.
- 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.
Roles & Responsibilities
- Possess over 10 years of experience in Clinical Operations or a related role, engaging with CROs and other vendors, and progressively assuming more significant roles.
- 5-7 years of experience overseeing CNS Clinical Trials
- Familiarity with FDA/EMA regulations and ICH/GCP guidelines is essential, accompanied by prior involvement in collaborative, cross-functional settings.
- Proven track record in the selection, management, supervision, and fruitful cultivation of productive partnerships with multiple vendors and CROs.
- Highly motivated and enjoys working in a fast-paced, dynamic environment
- Strong organizational skills and ability to prioritize and multi-task
Benefits
- Competitive compensation
- 401(k), Medical, Dental, Vision
- Performance based bonuses and incentives
