Clinical Project Manager
San Diego Metro Area, California
- The Project Manager must have prior clinical operations experience and is responsible for the cross-functional leadership of the Data Management, Biostats, and Medical Writing deliverables. This position provides project management related to development and execution of product programs to achieve short and long term team goals, including but not limited to NDA submissions activities. The incumbent works closely with clinical, manufacturing, regulatory, and other matrix based cross functional areas. Functions to recommend and achieve milestones on time/on budget as well as communicate to management.
Project manages teams within cross-functional groups with the execution of product development plans and operations to ensure continuity across the development lifecycle.
Leads the proper identification, integration and allocation of resources across multiple development efforts operating concurrently.
Optimize resources while avoiding critical resource bottlenecks that impede progress against time.
Ability to clearly define and execute the overall strategy and timelines.
Act as a liaison to outside vendors/CRO s to ensure timely delivery of agreed upon milestones.
Ensure overall, integrated strategic, scientific and operational input to individual study protocols through both personal input and coordination of input from other subject matter experts.
Manage departmental budget to ensure planning and spending is consistent with established corporate operating expense goals.
Lead Product Development teams in collaboration with Regulatory Affairs to provide timely support planned regulatory submissions.
Ensure collaboration within Clinical Development to ensure appropriate Program support for safety activities.
Other responsibilities as assigned.
Knowledge and Skill Requirements:
BS/MS in Biology or related field / MBA or PMP a plus.
Experience in Drug Development and Project Management with at least 5 years of experience in biopharmaceutical industry.
Late Phase development experience a plus.
In-depth experience in Finance, Clinical Development and Program Management operations; alliance management a plus.
Strong leadership and communication skills mandatory.
Demonstrated skill in strategic planning and operational excellence.
Ability to collaborate cross-functionally with individuals in a wide variety of disciplines and backgrounds and build strategic relationships.
Demonstrated ability to mentor individuals in leading, as well as functioning in a cross-functional environment.