Associate Director, CMC Dossier Strategy and Leadership

📋 Description

• Author and coordinate submission documentation for all phases of clinical development of synthetic
• Leverage extensive drug development experience to lead the global cross-functional CMC Team in
• Demonstrate excellent interpersonal skills, ability to develop important relationships with
• Develop standard processes and lead CMC project teams in planning, preparation, review and approval
• Embedded in the CMC team throughout development to collaborate on control strategy development and
• Participates in benchmarking activities to gather insights in industry trends and identify &amp

🎯 Requirements

• Bachelor’s with 12, Masters with 10, or PhD with 7 years of CMC functional experience including
• 2+ years of leadership experience managing a team of technical professionals.
• Interdisciplinary CMC experience required.
• Prior experience in a relevant laboratory-based CMC function (chemistry, analytical, formulation
• Excellent scientific writing skills including contributions to INDs and/or marketing applications
• Strong communication skills, written and verbal, with a demonstrated ability to summarize and

🎁 Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance and 401(k)
• Long-term incentive programs