Small anti-infectives, US based (northeast) drug sponsor to conduct 2 studies to support a new drug application. Study start up, first patient in target- end of Q1 2022.
Primary responsibility includes oversight of clinical study execution, including project planning,
resource management, CRA and CRO management, and ensuring all operational aspects of clinical
trials are executed effectively and in compliance with applicable regulatory requirements.
Specific responsibilities include, but are not limited to:
• Develop, implement and maintain study plans including, but not limited to, document
management and monitoring. Participation in protocol preparation and any country-specific
versions (as necessary).
• Plan, lead and coordinate all assigned activities of Study execution per timelines, including
site selection, regulatory document collection, IRB communication, site initiation, drug
release, site monitoring, data management, coordination of external parties such as steering
committees, and site close out in conformance to all relevant laws, regulations, guidelines,
and internal SOPs/policies. Review and approval of essential GCP documents required for
release of investigational product to investigational sites. Review of protocol deviations.
Develop corrective and/or preventative action plans with Management and Quality to
address any deficiencies.
• Act as the primary point of contact for the study and manages day-to-day communication and
activities of the Study team. This includes internal and external team members, vendors and
corporate partners. Provide study-specific training as required.
• Experience leading teams of 3-10 people and managing performance.
• Collaborate with project team members to develop outsourcing specifications for the
selection of high-quality service providers. Participate with vendor selection (such as CROs
and central laboratories); assist in the development of the scope of work, and ensure
effective tracking of study progress, data quality and vendor performance, per pre-specified
metrics. Communicate progress with Study execution/timelines with Management.
Education and Training
Bachelor’s degree in a scientific or healthcare discipline and a minimum of 10+ years of
clinical development experience in the pharmaceutical and/or biotechnology industry
including management of CRO
• 10 or more years leading clinical project teams, early thru late-stage trials.
• 5+ years of NDA/EU submissions and requirements
• Experience working in a medium to large pharmaceutical company
• Prefer experience in Infectious Disease protocols.
• Knowledgeable in Pharmacovigilance and management of budgets