Director, Program Management - Cell Therapy

DIRECTOR, PROGRAM MANAGEMENT (Cell Therapy)

Boston, Massachusetts - United States

Seeking a dynamic and highly experienced and motivated Program Manager to join a very small clinical-stage biotech. This new hire would need to wear multiple hats in order to run with multiple programs (including a large phase III trial), and be the liaison between cross-functions, consultants, and external employees. If you are highly strategic and have the ability and the drive to master execution from the early stage to phase III of drug development, then you'd do very well in this role. Will work closely with the team, cross-functions, and upper management on strategies to drive successful executions for their AAV Gene Therapy programs and robust portfolio.

Responsibilities:

• Responsible for the delivery and timeliness of Programs/Projects/Features under their purview.
• Mentoring staff, acting as a point of escalation, conducting performance evaluations, and creating a culture that promotes performance.
• Drive cross-functional, strategy development, program planning, and execution.
• Oversees all program management activities and ensures strategy, support, implementation, and execution of trial studies per company plans and timelines, and within budget for their multiple clinical programs.
• Mentoring staff, acting as a point of escalation, conducting performance evaluations, and creating a culture that promotes performance.
• Ongoing strategic discussions and meetings with Project Team throughout the project lifecycle to assist with tasks as setting up new processes.
• Work with and support management with strategies on studies or programs.
• Prepare plans and documents for team meetings. Work with and support management with strategies on studies or programs.
• Writing sections of regulatory documents (IND, NDA)

Requirements:

• Bachelor's degree in a Scientific discipline is required; Advanced degrees or medical graduates or other Life Sciences are strongly desired (MBA and Ph.D. are preferred).
• Over 7 years of industry experience in a biopharmaceutical setting.
• 4 years of Program Management experience overseeing multi-disciplinary development teams across all stages of drug development within the pharmaceutical industry.
• Must have direct drug development experience.
• Strong understanding and background in regulatory, especially regulatory Writing, and has authored sections of INDs and NDAs.
• Toxicology background
• Strong experience across the drug development; early-stage to phase III experience.
• Cell and Gene Therapy therapeutic focus is required.
• Experienced working on AAV Gene Therapy programs.
• Prior experience working in a matrix environment.
• Leadership and prior management experience

If you meet the above qualifications and interested in learning more, please contact Bria Gaber at bria.gaber@investigo-us.com for more information.