Sr. Program Manager

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.

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 deliver broad impact
• Experience working with senior leadership and presenting to executive stakeholders
• Excellent written and verbal communication skills; able to synthesize complex topics into clear, actionable plans
• Highly motivated, detail-oriented, and adaptable in fast-paced, dynamic environments

Preferred Qualifications

• Prior experience in biopharmaceutical launch
• Project Management Professional (PMP) certification is preferred.
• Knowledge of Design Controls under US and International Regulations preferred.
• Proven ability to think strategically, plan and align product development with business goals and market needs.
• Naturally accountable, a self-starter, self-motivated, self-directed, self-sustaining.
• Outstanding communication and presentation skills, written and verbal, to all levels of an organization.

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the candidate’s qualifications, consistent with applicable law.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.

Accommodation & Accessibility Notice:

Intuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process, please contact People Services at [email protected].