Sr. Program Manager

📋 Description

• Lead cross-functional teams through all stages of small molecule drug development, from preclinical
• Drive end-to-end program lifecycle – initiation to closure – ensuring stakeholder alignment and
• Oversee CMC timelines and deliverable completion for activities that include process development
• Coordinate with Nonclinical activities such as toxicology, PK/PD, safety pharmacology, and ADME
• Partner with Regulatory Affairs to develop and implement regulatory strategy toward NDA completion
• Develop and maintain integrated project plans covering scope, timelines, budgets, resources, and

🎯 Requirements

• Advanced degree in life sciences, pharmaceutical sciences, or related field (PhD, PharmD, MS, or
• Minimum of 8 years of experience in the pharmaceutical/biotech industry, with at least 5 years in
• Proven track record managing small molecule development programs through IND-enabling studies and
• Experience with CMC, regulatory submissions, clinical operations, and non-clinical activities
• Strong understanding of the drug development lifecycle, from discovery through commercialization
• Familiarity with global regulatory requirements (FDA, EMA, ICH guidelines) and compliance standards