Associate Director, CMC Dossier Strategy & Leadership

📋 Description

• Author and coordinate submission documentation for all phases of clinical development of biologics
• Leverage extensive biologics drug development experience to lead the global cross-functional CMC
• Demonstrate excellent interpersonal skills, ability to develop important relationships with
• Manages completion of CMC regulatory submission documentation for multiple projects of moderate
• Serve as the primary Dossier Strategy & Leadership (DSL) representative to interface with the
• Partner with CMC Regulatory to assist CMC project teams in identifying submission-related risks and

🎯 Requirements

• Bachelors Degree with at least 8-10 years of CMC experience required; Masters Degree with at least
• Interdisciplinary experience required, biologics experience strongly preferred.
• 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
• Demonstrated ability to make decisions based on scientific data, to manage and prioritize multiple
• Demonstrated skills in negotiation, influencing others, and leadership.

🎁 Benefits

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick)
• This job is eligible to participate in our long-term incentive programs.