The Senior Director, Development Sciences Licensing & Acquisitions leads a specialized team responsible for evaluating external pipeline opportunities, overseeing due diligence activities, and guiding Chemical, Manufacturing, and Controls (CMC) strategies for licensing and acquisitions across multiple therapeutic areas. The role is pivotal in assessing and integrating technical, regulatory, and operational considerations for external innovations, ensuring successful transitions into internal development pipelines.

Responsibilities:

• Build and manage a high-performing team dedicated to technical evaluation of novel drug substances, drug products, devices, and platforms. Partner with key technical SMEs to evaluate opportunities and understand impact across technical functions.
• Lead CMC due diligence activities, including comprehensive technical assessments, risk mitigation, and integration of CMC strategy with clinical development plans for business development opportunities.
• Serve as the primary CMC representative in cross-functional evaluations with R&D, Regulatory Affairs, Operations, Quality, Finance, and Commercial teams, influencing decision-making and integrating CMC perspectives into overall business strategy.
• Prepare and present balanced technical recommendations, risk analyses, and findings to senior management and governance forums.
• Ensure seamless transition and knowledge transfer of externally sourced assets into internal product development pipelines, coordinating with project management and technical teams.
• Support post-deal integration and development/resource planning to ensure continuity of clinical.
• Monitor industry and regulatory developments in CMC, manufacturing, and compliance, adapting strategies to the evolving landscape.
• Manage multiple concurrent CMC diligence projects across various asset types and therapeutic areas in a fast-paced environment.
• Build and maintain best in class licensing and acquisition processes to move projects forward in the most efficient and effective manner and provide recommendations for dismissing ideas early and effectively.