Our client is a global, clinical stage biopharmaceutical company focused on the development of an innovative pipeline of new chemical entities with known mechanisms of action targeting underserved patient populations in organ protection and infectious diseases. Our client utilizes an integrated discovery and development platform that enables the company to efficiently bring new therapies from bench to patients around the world.

PRIMARY DUTIES:

• Serves as the leader and coordinator for implementation of clinical trial activities and management of the clinical trial(s), from study start up through to CSR completion;

• Assist in development operational strategy (including ancillary vendors) for clinical studies;

• Manage CROs and external vendors to ensure studies are conducted to according to project plan and ICH guideline;

• Ensure studies are completed on budget;

• Lead risk assessment, develop contingency planning and risk-mitigation strategies at the project level

• Approximately 6-8 years of project management experience, preferably with a sponsor company (CRO experience a plus) managing outsourced global Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (~20%-30% potential travel, adjusted as necessary for COVID-19).

• clinical trials within quality, timeline, and budget expectations.

• Prior investigator site and/or monitoring experience is advantageous

• Deep understanding of clinical development within one or more Phases of trials (Phase I, II, III, IV) and a working understanding of cross functional drug development.

• Scientific learning agility to quickly develop a sound working knowledge of new therapeutic areas.

• Ability to establish operational plans and support the CRO in the execution of the plans.

• Requires a balance of scientific and operational/project management and team leadership expertise.

• Must be able to build effective relationships across and up and down the organization.

EDUCATION AND EXPERIENCE: 

• Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (~20%-30% potential travel, adjusted as necessary for COVID-19).

• B.A. or B.Sc. in a scientific discipline; advanced degree preferred. Scientifically and clinically astute with very strong project management skills.