Drug Development Program Manager

Overview

Our client is seeking a Drug Development Program Manager to support both early-stage development programs (IND/CTA preparation and transition into clinical development) and late-stage programs supporting major regulatory submissions. This individual will partner with Global Program Leads (GPLs), Global Project Managers (GPMs), Clinical Science, Therapeutic Area leadership, and cross-functional teams to drive Integrated Development Plans (IDPs), strategic execution, governance, and risk management across the drug development lifecycle. Candidates should possess experience supporting early-stage development programs, major product submissions, or ideally both.

Responsibilities

• Partner with GPLs, GPMs, Clinical Science, and cross-functional stakeholders to develop and execute drug development strategies.
• Develop and manage Integrated Development Plans (IDPs), program timelines, milestones, and critical path activities.
• Lead cross-functional planning and execution across Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, CMC, Safety, and Nonclinical functions.
• Support programs from IND-enabling activities through clinical development and key regulatory submission milestones.
• Lead planning activities for early-stage programs, including IND/CTA preparation and early clinical development.
• Support late-stage development programs and major regulatory submissions, ensuring cross-functional readiness and execution.
• Drive governance, risk management, scenario planning, resource forecasting, and budget planning activities.
• Partner with Clinical Operations to support enrollment, study execution, and issue resolution.
• Drive accountability across matrixed teams and prepare executive-level communications and governance materials.
• Promote operational excellence and continuous improvement initiatives.

Qualifications

• Bachelor's degree required.
• 8-10 years of experience within pharmaceutical, biotechnology, or drug development organizations.
• Experience supporting development programs from IND-enabling activities through clinical development.
• Experience supporting early-stage development programs, including IND/CTA preparation.
• Experience supporting late-stage development programs involving major regulatory submissions (NDA, BLA, MAA, etc.).
• Strong understanding of the drug development lifecycle, including clinical, regulatory, nonclinical, and CMC activities.
• Experience leading complex cross-functional development programs within matrixed organizations.
• Strong program planning, governance, risk management, stakeholder management, and budget/resource planning skills.
• Excellent communication, presentation, and executive-facing skills.
• Ability to work onsite 2-3 days per week (50%) in Princeton, NJ, Cambridge, MA, or Brisbane, CA. This requirement is non-negotiable.

Preferred Qualifications

• Neuroscience drug development experience strongly preferred.
• Advanced scientific or business degree (MS, MBA, PharmD, or PhD) preferred.
• PMP certification is a plus.
• Experience with Microsoft Project, Office Timeline, and similar project planning tools.