The Senior Director, Drug Development Project Management will manage assigned project (s), including program’s strategic direction, integrated project plan, alliance management, cross-functional deliverables as required by the International Project Team. This role requires interaction with, and management of, internal cross-functional team members, business partners, and contractors.
Oversees the development of compounds from candidate selection to NDA/MAA filing for the assigned project (s) in the Alzheimer’s Disease and Brain Health Group at The company, in accordance with agreed to development plans and corporate objectives.
Advanced understanding of clinical research and the clinical drug development process
Advanced understanding of the Neurology therapeutic area
Advanced understanding of the drug development plans, preclinical toxicology, toxicology, CMC, regulatory and other development requirements as they relate to efficient execution of the development plans.
Advanced understanding of clinical trial management, including general understanding of all specialized support functions.
Ability to lead a team of cross-functional experts and influence without authority
Ability to effectively prioritize work and engage in creative problem solving to manage global projects.
Pro-actively identify, analyze, and resolve project issues to ensure project milestones are met and projects are completed, with quality, on time and within budget.
Ability to work independently, with strong organizational, communication and interpersonal skills (works well with all levels of staff in a professional manner)
History of working in complex team environments with numerous and diverse key stakeholders in multiple regions
Bachelor’s degree is required. An advanced degree is desirable (MS or PhD). PMP is desirable.
Minimum of 12+ years’ experience in the biotech/pharmaceutical industry in the phase 2 -3 development space.
Expertise in integrated drug development knowledge with solid understanding of the Neurology therapeutic area and the ability to contribute to strategic discussions
Demonstrated leadership skills, including situational leadership
Demonstrated competency in deploying project management methods and influencing work processes that span across departments and geographic boundaries.