Senior Manager, Clinical Affairs

Intuitive•Sunnyvale, CA

About The Position

The Senior Manager, Clinical Affairs contributes to clinical strategies and oversees study execution for emerging technologies across multiple specialties. The clinical portfolio may include U.S. and global first-human-use and pivotal trials intended to support regulatory submissions. The role oversees clinical protocols and other study documents, clinical publications and evidence dissemination, and communications with clinical trial sites, CROs, key opinion leaders, and medical societies. It develops and manages a team that supports the company’s clinical requirements in accordance with applicable guidelines and regulations, while anticipating challenges and developing methods to address them. As a functional manager, the position leads and develops clinical operations personnel, including clinical study managers and clinical research associates. The role works cross-functionally with Regulatory Affairs, R&D, the Program Management Office, Clinical Research Engineering, Clinical Research Managers, Global Access Value Economics, Global Public Affairs, Regulatory Compliance, Training, Legal, and commercial functions to align study strategies with business objectives. The position also manages study resources and budgets, supports regulatory strategies and submissions, and ensures clinical studies are conducted on schedule, within budget, and in compliance with corporate and regulatory requirements. Travel of up to 30–40% is required. Intuitive or its customers may require current proof of vaccination against certain diseases, including COVID-19, depending on the role.

Requirements

Bachelor’s or master’s degree in a scientific field, or MD or PhD, with 12 or more years of professional experience.
At least 3–5 years of supervisory experience is preferred.
At least 5 years of experience independently managing clinical studies through multiple phases, including pre-IDE, IDE submission, site selection and activation, study execution, data analysis and reporting, and closeout.
Excellent clinical operations and project management skills, including experience collaborating with or leading cross-functional teams.
Demonstrated ability to manage cross-functional relationships and key opinion leaders.
Strong experience managing clinical study resources and budgets.
Strong experience supporting clinical study scientific and regulatory strategy development.
Strong experience developing protocols and other study documents, conducting literature reviews, and writing clinical sections of regulatory submissions.
Knowledge of 21 CFR Part 812, Good Clinical Practice, ISO 14155, and other regulations and guidelines.
Basic understanding of statistics, statistical methods, and design of experiments.
Ability to interact effectively with physicians and other professionals inside and outside the company.
Strong communication, presentation, interpersonal, organizational, and detail-oriented skills.
Results-driven approach, strong problem-solving skills, and dedication to meeting aggressive timelines or managing multiple projects as needed.
Ability to travel up to 30–40%.
Must meet any applicable customer or company vaccination-proof requirements for certain diseases, which may include COVID-19.

Nice To Haves

Previous experience supporting internal and external audits of clinical studies.
Comfort working in a hospital environment and experience working with nurses and surgeons.
Existing or previous experience or familiarity with surgery or surgical technology.
Three to five years of supervisory experience is preferred.

Responsibilities

Contribute to the company’s clinical study strategy and align studies with business goals and objectives.
Collaborate with internal stakeholders and key opinion leaders to develop and review study concepts, protocols, outlines, and related initiatives.
Partner with Regulatory Affairs to support regulatory approval of new products and contribute clinical sections to regulatory submissions.
Manage clinical study resources and budgets to keep studies on schedule and within budget while maintaining quality and compliance.
Build and maintain relationships with investigational sites and investigators for ongoing and future studies.
Work with data management on case report form development and data cleaning to support high-quality data collection.
Work with biostatistics on study design, statistical analysis plans, analysis, interpretation, and synthesis for clinical study reports and scientific publications.
Ensure compliance with corporate procedures, including SOPs, and regulatory requirements, including GCP and U.S. FDA requirements; review departmental procedures and lead process improvement initiatives.
Set effective goals that support the department and organization.
Lead direct reports, provide ongoing guidance, support their communication, and help them achieve goals and objectives.
Hold individuals and the team accountable for competency and performance standards.
Clarify complex issues, set actionable direction, help the team prioritize and solve problems, and enable progress.
Develop talent and build an effective team of clinical study managers and clinical research associates.
Manage clinical protocols and other key study documents, publications, evidence dissemination, and communications with sites, CROs, KOLs, and medical societies.
Anticipate challenges and develop concepts and methods to overcome them.