Sr. Program Manager Job Sunnyvale area,California USA,Business

Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do a global leader in robotic-assisted surgery and minimally invasive care, our technologies like the da Vinci surgical system and Ion have transformed how care is delivered for millions of patients worldwide.

We're a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human.

Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration.

The work is challenging, but deeply meaningful because every improvement we make has the potential to change a life.

Fluorescence Imaging at Intuitive Surgical

The Fluorescence Imaging Team at Intuitive is developing agents designed to work seamlessly with Intuitive's robotic platforms and Firefly imaging technology. The agents have the potential to highlight critical anatomy and disease in real time - giving surgeons clearer information at the moment decisions matter most and helping improve outcomes for patients.

If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here.

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.

Qualifications Basic 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.
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.
Strategic thinker with excellent problem-solving, organizational, and risk management capabilities.
Strong interpersonal skills with a demonstrated ability to influence without authority to…