The Director, Program Management is accountable for the successful delivery of drug development programs according to the program strategy in all phases of development, lifecycle management projects, regulatory submission projects or sub projects within a major program. In collaboration with the Project Leader, the responsibilities of the Program Manager include leadership of the team in predicting and planning solutions to achieve successful operational execution; driving the team to achieve clarity on issues and focus on effective contingencies; managing external partners/collaborators; interfacing with senior management and influencing decision-making on projects.
Proven leadership experience in managing a global, cross-functional team with demonstrated skills in strategic planning, risk mitigation, and operation problem solving.
Solid working knowledge of functional BLA and NDA components/requirements required.
Ideal candidate has worked on a program(s) that lead to successful regulatory approval (i.e., NDA, BLA, MAA, or SNDA).
Experience in bone and breast cancer or related therapeutic program preferred. Experience with combination products is a plus.
Excellent verbal, written, and organizational communication skills.
Strong interpersonal skills with the ability to motivate others, influence without authority and develop important relationships with key stakeholders.
Ability to drive decision-making within cross-functional teams.
Proficient in Microsoft Office including Word, Excel, PowerPoint, Project, Sharepoint, Outlook and Visio.