Clinical Operations Manager (m/f/d)

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.

We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world's first and only chikungunya vaccine, as well as certain third-party vaccines.

Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats.

Responsibilities

• Responsible for all aspects of one or more phase 1-4 clinical studies from protocol through clinical study report finalization for regulatory submission
• Ensures compliance with ICH-GCP and FDA/EMA regulations, other regulations, and SOPs, as applicable
• Ensures all operational study deliverables are met according to timelines, budget, operational procedures, and quality standards
• Manages CROs and other external partners and ensures adherence to scope of work within timelines and budget
• Interacts with other departments and relevant functional areas
• May be required to travel to supervise and coordinate clinical studies