Associate Director / Director, Program Management

The Associate Director / Director, Program Management will lead one or more cross-functional drug development program teams including research, development, and commercial representatives.

Essential Duties/Tasks

• Lead and coordinate all cross-functional activities related to clinical development, CMC, and regulatory for a new therapeutic
• Develop integrated development plans and drive execution. Anticipate issues and proactively mitigate risks and roadblocks. Direct program team to achieve targets within appropriate quality standards, deadlines, budget, and resources
• Drive program level decision-making
• Ensure appropriate and effective communication within the program team, senior management, and the executive team, including the CEO
• Represent development point of view in commercial planning and decision making
• Provide formal and informal reports of program status to stakeholders

Education and Experience

• Master's Degree in a life science or related field or equivalent experience
• At least 10 years project management experience in drug development in the pharmaceutical industry, including Phases 1-3, regulatory filings and product launch
• PMP or other Project Management Institute certification

Skills, Qualifications, or Technical Proficiencies

• Demonstrated leadership skills and ability to manage, motivate, and integrate complex, cross-functional development teams
• Analytical skills and ability to focus on both details and the big picture
• Excellent interpersonal, problem solving, and influence/negotiation skills
• Knowledge of regulatory guidelines for drug development functions (ICH and FDA)
• Able to navigate uncertainty with creative problem solving
• Ability to achieve business results with colleagues of diverse levels, functional expertise, skills, and priorities. Effective as both a team player and a team leader
• Ability to take a hands-on, "roll up your sleeves" approach