- Robot type
- Surgical and Medical
- Location
- SunnyvaleCaliforniaUSA
- Job type
- Product
- Posted
- Sep 16, 2026
Sr. Program Manager
Job description
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.
Job 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…
- 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
Job requirements
- Advanced degree in life sciences, pharmaceutical sciences, or related field (PhD, PharmD, MS, or equivalent strongly preferred).
- Minimum of 8 years of experience in the pharmaceutical/biotech industry, with at least 5 years in program management.
- Proven track record managing small molecule development programs through IND-enabling studies and clinical phases to NDA Submission.
- 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 (GxP).
- Advanced program management skills with experience in budgeting, forecasting, and scenario planning.
- Ability to communicate complex issues clearly to both technical teams and executive leadership.
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