Senior Director / Executive Director, Small Molecule Chemistry, Late-Stage Development

About the role

The Senior Director / Executive Director, Small Molecule Chemistry, Late-Stage Development role will lead the late-stage small molecule chemistry group, overseeing drug substance process development, scale-up, and commercialization.

Responsibilities

• Create a high-performance team culture that operates with clarity of roles, responsibilities, and expectations for both individuals and the team.
• Actively manage internal and external resources, including CMOs and external partners, to drive late stage small molecule chemistry development across the portfolio.
• Ensure safety of employees and facilities through implementation of robust safety programs / procedures.
• Recruit, develop, and grow the next generation of scientific leaders.
• Provide strategic guidance to small molecule chemistry teams, including integration and application of new synthetic technologies, continuous and flow chemistry, green chemistry, and emerging process analytical technologies.
• Partner with cross-functional teams including Quality, Regulatory, and manufacturing to ensure seamless integration of development activities.
• Identify opportunities for continual improvement projects that optimize business processes related to late stage small molecule chemistry development and drug substance manufacture.
• Possess deep understanding of the portfolio, project objectives, and how the technical programs and teams are poised to deliver on those objectives.
• Communicate and support execution of SMDD’s technical strategy.
• Evaluate the organization’s strengths and needs and drive appropriate changes.

Requirements

• Ph.D. in Organic Chemistry, Synthetic Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field, or BS with equivalent work experience.
• 10+ years of CMC experience.
• Direct experience in late phase development, scale-up, and commercialization of small molecule drug substances, including route selection, process development, and regulatory filings (IND/NDA/CTD Module 3, Section 3.2.S).

Qualifications

• Previous supervisory experience.
• Excellent communication (written and verbal).
• Exceptional teamwork/interpersonal/leadership/vision.
• External network and networking skills.
• Expertise in project planning/organization/management.
• Talent assessment and recruiting.