Associate Director / Director Clinical Operations
This company is a fast growing biotechnology company that specializing in bringing innovative and enhanced versions of successful CNS treatments to the US market. Their approach is to create a research-focused organization dedicated to generating novel intellectual property related to improved versions of these previously successful CNS drugs oversees that have never been developed, approved, or marketed in the United States.
The company is looking for a AD/ Director Clinical Operations who will play a pivotal role in driving and overseeing their ongoing clinical trial Phase 2 programs forward and ensuring the success of it.
In this crucial role, you will play a key part in overseeing clinical operations, with a specific focus on drug supply forecasting and Interactive Response Technology (IRT) systems. This candidate will report directly into the Senior Director of Clinical Operations.
- Develop and implement strategic initiatives for clinical operations to ensure the successful execution of clinical trials.
- Collaborate with our clinical operations team to oversee the ongoing Phase 2 clinical trial in schizophrenia.
- Provide leadership and guidance to the clinical operations team, fostering a collaborative and high-performance culture.
- Oversee the development and execution of drug supply forecasting strategies.
- Collaborate with cross-functional teams to optimize drug supply chain processes.
- Manage and optimize the implementation of Interactive Response Technology (IRT) systems for clinical trials.
- Collaborate with vendors to ensure the functionality, reliability, and compliance of IRT systems.
- Ensure adherence to protocol and regulatory requirements in clinical trial operations.
- Work closely with cross-functional teams, including Clinical Development, Vendors, Supply Chain, to ensure seamless collaboration and communication.
- May have to preform co-monitoring visits.
- Bachelor's Degree; an advanced degree in a scientific field is considered advantageous.
- Must come from Pharma/Biotech industry but open to CRO experience.
- Must have at least 10 years' experience in clinical operations.
- Must have Proven experience in clinical operations, with a focus on drug supply forecasting and IRT systems.
- CNS indications is preferred and experience in Schizophrenia clinical trial is a nice to have.
- Strong understanding of regulatory requirements and industry best practices.
- Must be able to go on site at least 1 days a week OR 1 week out of the month in Manhattan, NY.
- Up to 25% travel if needed to preform co-monitoring visits.
- Competitive salary.
- Liquid stock options package.
- Notable leadership and growth opportunities.