Study Start-Up Specialist
New Jersey (Hybrid)
$90,000-$100,000
Job Description
EPM is partnered with a company focused on creating novel therapeutic bi-specific, multi specific, and ADC's for cancer treatment. With their clinical stage assets, the data has been described as "the best I've ever seen" by industry leaders, and they signed a licensing agreement with a big pharma company at the end of last year worth multiple billion dollars. Given their science and financial backing along with the opportunity for growth, it's a really high potential opportunity. They're growing out a new office in New Jersey, so it's a very exciting time to join!
Roles and Responsibilities
- Prepare, compile, and submit regulatory documents and applications required for the initiation of clinical trials (e.g., IND applications)
- Collaborate with clinical operations and project management teams to identify potential investigational sites for clinical trials
- Facilitate contract and budget negotiations with investigational sties and vendors
- Ensure all study-related documents are prepared according to regulatory requirements and company standards
Key Qualifications
- At least 2 years of experience in a study start up focused role at a biotech or pharmaceutical company
- Experience in developing and maintaining project timelines and coordination cross-functional teams
- Familiarity with clinical trial protocols, informed consent processes, and study documentation preparation
- Ability to effectively communicate with internal teams, investigational sites, CRO's, and vendors
- High level of attention to detail to ensure accuracy and compliance in preparing regulatory documents and study materials
Benefits
- Medical
- Dental
- Vision
- 401(k)
