Associate Director, CMC Leadership

The Associate Director position is responsible for the technical leadership of cross-functional CMC Teams supporting small molecule program development from pre-nomination through commercialization. This individual will lead the integration of technical and regulatory strategies to set the overall CMC strategy to achieve the desired target product profile. This individual will represent the CMC Team as the primary point of contact to project teams and governance forums and will communicate regularly on key risks and challenges. The successful candidate will be an effective role model for the scientific/technical community in the company by effectively managing technical details and providing expert opinions. This is a highly collaborative role that requires successful collaboration with various functions to successfully move CMC projects forward. 

This is a hybrid role, 3 days/week in the office, based in Waltham, MA

Responsibilities

Major duties and responsibilities are: 

• Seek appropriate representation on the CMC Team from functional area management
• Ensure the trajectory of the CMC Team is such that it can meet CMC deliverables
• Facilitate cross functional scientific discussion, collaboration and decision-making
• Ensure alignment on data-driven decisions, prioritization and resourcing 
• Ensure risks are identified, documented and escalated as appropriate
• Ensure milestones are achieved in a timely manner
• Drive development of the overall product control strategy
• Provide Team recommendations, or select the appropriate functional area representative(s) to provide Team recommendations, that require external alignment and decision-making

Qualifications

Education and Experience:

• Bachelor’s and/or post-graduate degree with 8+ years relevant experience in small molecule product development 
• Late development (Phase 3 through commercialization) experience, preferred
• Demonstrated capability to effectively manage technical details

Knowledge/Skills Required

• Exceptional oral and written communication skills
• Excellent technical project management abilities
• Deep and thorough understanding of various aspects of small molecule product development
• Proven ability to apply scientific principles to design, execute, and interpret experiments
• Significant knowledge of cGMPs and applicable regulatory guidance
• Demonstrated ability to lead and collaborate within an interdisciplinary team environment on creative problem solving
• Sound understanding of analytical methodology 
• Adept with standard computer applications 

Travel

• Involves some travel (<10%)