Director Clinical Affairs

Opportunity to join a start-up Medical Devices company who have funding to take their novel technology to the strategic US market. An established Clinical team and set-up, you'll be responsible for overseeing the clinical activities from a CRO management and strategic standpoint for a product going through IDE trials that can change the outcomes for >70% of colon cancer patients.

Responsibilities:

• Develop and oversee clinical strategies of multiple (~20) clinical trials of varying size and complexity to support regulatory submissions within the US.
• Participate in investigator selection, recruitment, and training; Interacts with Investigators and study sites during study conduct
• Ensure the clinical studies are followed up in accordance with clinical protocols.
• Autonomously manage, and make decisions on, the clinical trials and how the CRO should be partnering themselves to ensure successful trail completion.

Experience Required:

• 8 years' of clinical experience in the Medical Devices industry, with proven track record of taking a leading role on successful clinical studies.
• Must have experience working for the sponsor.
• Experience working remotely and/or in a start-up environment is highly preferred.
• Previous Class III medical device experience is highly preferred, as well as management experience as there will be potential to start and build a team over the years.
• Based on the US East Coast.