Senior Director, Program Management

Role Overview

• Work with the leadership team to develop pipeline strategies and build high-performing teams that can deliver defined business solutions
• Develop and deliver on project plans to guide programs while managing risk, contingencies and/or corrective actions
• Lead and manage the project management function
• Define and direct the technical approach to project management
• Lead and provide effective project/program leadership of the development team to deliver high-quality projects/programs with clear boundaries and outcomes on time and within budget
• Work in partnership with the Leadership Team to develop and implement overall project/program strategy
• Align development plans across Regulatory, Clinical, R&D, Pharmacology-Toxicology and CMC
• Interface with Regulatory Affairs to develop global regulatory strategy and plans
• Provide cross-functional leadership for the strategic planning of integrated development plans for programs, starting at first-in-human through registration
• Co-chair cross-functional project/program team meetings to ensure appropriate action plans are created and implemented
• Set realistic yet aggressive timeframes for achieving objectives with team buy-in and alignment
• Lead cross-functional project/program team(s) to prepare Target Product Profile and global development plan to deliver differentiated products, leveraging the scientific and medical leadership of the Leadership Team
• Define and implement a communication strategy/plan for the program that supports the most effective team empowerment and progress
• Act as an appropriate role model/coach/mentor to facilitate the success and development of individuals within the teams and the team as a whole

Requirements

• Minimum of a Bachelor’s degree
• Minimum of 12 years of relevant experience
• Proven track record of experience in drug development, especially with project/program leadership of cross-functional teams
• Demonstrated experience planning, managing and completing one or more large, complex projects with teams of 30+ individuals, 18+ month duration and implementation cost of $20M+, engaging varied functional stakeholders
• Experience leading programs through the complexity of Phase 3 and regulatory submission readiness
• A strong understanding of the biotech drug development process and regulations
• Strong written and verbal communication skills with a collaborative, team-oriented approach
• Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
• Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude