Senior Program Manager, Drug Development

Socket.dev; Sunnyvale (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

Intuitive Surgical in Sunnyvale, CA is seeking an experienced Senior Program Manager to oversee cross-functional development programs for small molecule therapeutics. You will align CMC, non-clinical, clinical, and regulatory functions to ensure programs are executed on time, within budget, and in compliance with global standards.

The role leads integrated teams, reports progress to executive leadership, and mitigates risks across technical, regulatory, and financial dimensions.

Qualifications

• 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.

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
• 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.

Skills

Cross-functional leadership

Program management

Regulatory submissions

Budgeting & forecasting

Risk management

Communication to executives

Stakeholder influence

Clinical development knowledge

Education

PhD/PharmD/MS or equivalent

Job description

Intuitive Surgical in Sunnyvale, CA is seeking an experienced Senior Program Manager to oversee cross-functional development programs for small molecule therapeutics. You will align CMC, non-clinical, clinical, and regulatory functions to ensure programs are executed on time, within budget, and in compliance with global standards.

The role leads integrated teams, reports progress to executive leadership, and mitigates risks across technical, regulatory, and financial dimensions.