Director Clinical Operations
USA (Remote)
$200,000 - $235,000
Job Description
A Global, commercial stage biotech focusing on creating novel cell therapeies in the oncology space is looking to grow as they hire a Director of Clinical Operations. With a drug already approved (in the US and EU), they are backed by a proven drug platform and tons of financial stability. What makes this opportunity interesting is that they are still in a growth phase, so there is vast opportunity for vertical mobility within. With a robust pipeline, and partners from various large pharmaceutical companies, opportunities like this don't come around often.
Key Qualifications
- Bachelor's degree in a life science related field
- 10+ years of oncology experience at a Biotech or Pharmaceutical company (not CRO)
- Regulatory authority inspection experience highly preferred
- Experience planning and managing T-Cell therapies required
- Excellent verbal and written communication skills, with the ability to effetively communicate with internal teams, external stakeholders, and study sites.
- Strong understanding of regulatory requirements governing clinical trials, including FDA regulations, ICH-GCP guidelines, and other relevant standards
Roles and Responsibilities
- Manage, mentor, and oversee the development of new clinical staff and a small number of CTM's
- Facilitate end to end clinical trial management activies both domestically and globally, including study planning, start up, and execution
- Oversee vendor selection and manage various CRO's and vendors
- Define timelines and deliverables while working closely with the Senior Director Clinical Operations
- Oversee site selection, initiation, and ongoing monitoring activities to ensure sites are conducting trials according to protocol and in compliance with GCP standards
Benefits
- Medical
- Dental
- 401(k)
- PTO
