Senior Director, Pharmaceutical Strategy and Development Leader

Role Summary

The Senior Director, Pharmaceutical Development Team Leader (PDTL) is responsible for developing and leading the execution of comprehensive, compound-specific Technical Operations strategies to meet the global project team's needs. This role provides leadership to interdisciplinary teams, managing multiple assets through various stages of development, and collaborates with various functional areas to achieve optimal development and business results.

Responsibilities

• Develop, refine, update, and oversee Technical Operations project plans from multiple inputs, with emphasis on the alignment of these plans with strategic objectives, the decomposition of major objectives into discrete WBS-level work packages, the mapping of internal and cross-functional interdependencies, and the management of project risks.
• Perform detailed scenario planning where significant ambiguity is present and map out the scope, cost, timeline, and risk aspects of each scenario.
• Provide leadership to interdisciplinary matrix teams responsible for developing and executing compound-specific integrated Technical Operations strategies.
• Manage multiple assets from candidate nomination to commercial formulation and manufacturing processes.
• Represent the Technical Operations organization on GPTs and collaborate with Clinical, Commercial, Regulatory, and other functional areas to integrate Technical Operations plans/activities into GPT goals and objectives.
• Communicate and partner effectively with stakeholders to define and execute Technical Operations strategy for projects.
• Identify and escalate key issues and risks, as well as resource allocation needs.
• Critically review relevant documents, including Technical Operations regulatory submissions and briefing booklets.
• Promote best practices and lead improvement opportunities.
• Partner with the Corporate Development to support Due Diligence evaluations.

Qualifications

• MSc or PhD in a relevant technical/scientific discipline.
• 15+ years of CMC experience in all phases of development, including regulatory submission (IND, NDA/MAA, IMPD) experience with a strong track record of success.
• Broad and sound understanding of process chemistry, drug product development, and analytical development.
• Proven track record in CMC development of clinical stage programs.
• Experience in multiple modalities is preferred.
• Solid understanding of CMC integration with Non-Clinical and Clinical development, Quality, Regulatory, and Commercial areas.
• Demonstrated strong project management experience.
• Relevant strategic and tactical project leadership experience.
• Excellent verbal and written communication skills.
• Experience in leading empowered, highly collaborative matrix teams.
• Keen sense for value of investment and ability to manage ambiguity.

Education

• MSc or PhD in a relevant technical/scientific discipline.

Travel

• You may be required to travel for up to 30% of your time.