Sr. Program Manager
Listed on 2026-09-20
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Management
Regulatory Compliance Specialist, Project & Program Management, Operations Management
Job Description
Primary Function of Position
We are seeking an experienced Senior Program Manager to oversee and drive cross-functional development programs for small molecule therapeutics. This role will provide leadership and coordination across CMC, non-clinical, clinical, and regulatory functions, ensuring that programs are executed on time, within budget, and in compliance with global regulatory standards.
The Senior Program Manager will serve as the primary point of accountability for assigned programs, leading integrated teams, and reporting progress and risks to executive leadership. The ideal candidate brings broad drug development expertise, strong organizational skills, and the ability to influence and motivate diverse stakeholders to achieve program goals.
Roles and Responsibilities
- Lead cross-functional teams through all stages of small molecule drug development, from preclinical through late-stage clinical studies
- Drive end-to-end program lifecycle – initiation to closure – ensuring stakeholder alignment and objective clarity
- Oversee CMC timelines and deliverable completion for activities that include process development, manufacturing, analytical methods, formulation, stability, and clinical supply readiness across multiple suppliers to ensure that materials are delivered on time and within budget
- Coordinate with Nonclinical activities such as toxicology, PK/PD, safety pharmacology, and ADME studies to enable on time regulatory submissions
- Partner with Regulatory Affairs to develop and implement regulatory strategy toward NDA completion and submission
- Develop and maintain integrated project plans covering scope, timelines, budgets, resources, and risk management strategies
- Track progress against milestones, anticipate issues, and implement corrective actions when necessary
- Provide clear, concise updates and presentations to executive leadership, governance committees, and external stakeholders
- Identify and mitigate program risks across technical, regulatory, operational, and financial dimensions.
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