Director, Project Management and Regulatory Operations

Company Name:
Bottom Line Staffing
An early-stage biotechnology company developing the next generation of cancer immunotherapies has an opening for a Director, Project Management and Regulatory Operations.
In this role you will provide cross-functional Project Management expertise and leadership to clinical, regulatory, manufacturing and quality and alliance partnerships, and assist manufacturing and regulatory leads with execution of regulatory commitments and filings.
KEY RESPONSIBILITIES:
Collaborate with the Manufacturing, Clinical Operations, Regulatory and Development departments as well Alliance Partners to ensure required activities are performed to advance the global clinical development and commercialization programs.
Identify and implement project management tools to monitor and improve clinical, regulatory and commercialization project timeline compliance.
Ensure that risks to projects activities and timelines are escalated to
executive
Management in a timely manner. Provide solutions to and execute risk mitigation activities. Evaluate the effectiveness of the mitigation activities and provide feedback to Executive Management.
Provide expertise and training to other departments in support of project management activities.
Assist manufacturing lead and regulatory lead with the development and execution of regulatory filings in a timely and compliant manner, including the ability to initiate and complete regulatory filings with minimal oversight.
Review corporate communications to ensure representations are consistent with estimated corporate timelines and consistent with regulatory requirements.
Assist with the development of quality systems and implementation as necessary to comply with regulatory requirements, including the development and implementation of cross - functional SOPs.

QUALIFICATIONS:
Bachelor's degree in a scientific discipline or management discipline required
A minimum of ten years of pharmaceutical experience, with at least three years in regulatory and/or clinical development project management
Experience in executing regulatory project management within the stages of clinical development and CMC
Experience in project management for Phase I, II, III clinical operations
Experience working with alliance partners, third party contract manufacturing or testing organizations

For consideration and more information, send resume to
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