Sr Program Manager - Drug Development (onsite)

Role Summary

Senior Program Manager to lead cross-functional teams in developing strategies for drug development programs, partnering with Program Leads to create and execute comprehensive program plans from preclinical stages through regulatory approval and commercialization.

Responsibilities

• Program Strategy & Execution: Collaborate with Program Leads and cross-functional teams to develop and execute strategic plans.
• Schedule & Resource Management: Establish and maintain functionally integrated program schedules, forecast and manage resources and budgets.
• Risk Management: Identify and plan risk responses; lead scenario planning for milestones.
• Cross-Functional Collaboration: Facilitate communication and alignment across pre-clinical, CMC, clinical, regulatory, and commercial functions.
• Stakeholder Interaction: Build relationships with stakeholders at all levels, manage escalation, contribute to decision-making and strategic alignment.
• Process Improvement: Lead program management process improvements and serve as a resource for the broader organization.

Qualifications

• Education: Bachelor's degree in Life Sciences with 8+ years of multi-disciplinary experience in the pharmaceutical/biotechnology industry; Master‚Äôs degree with 6+ years; or PhD with 4+ years. PMP Certification preferred.
• Leadership Skills: Ability to lead, mentor, and align cross-functional teams; manage conflict and promote decision-making.
• Project Management Expertise: Knowledge of project management in drug development; proficiency with project management software (e.g., Smartsheet, MS Project, Planisware, OnePager, Office Timeline or similar).
• Industry Experience: Significant experience in pharmaceutical/biotechnology industry, managing early and/or late phase global drug development efforts, including IND/CTA, NDA/MAA submissions, global clinical studies, pediatric development, rare diseases, small molecule and biologic modalities.