Senior Manager, Clinical Affairs

Intuitive•Sunnyvale, CA

About The Position

The Senior Manager of Clinical Affairs contributes to clinical strategies and oversees study execution for emerging technologies across multiple specialties. The portfolio may include U.S. and global first-human-use and pivotal clinical trials intended to support regulatory submissions. The role manages clinical protocols and other study documents, clinical publications and evidence dissemination, and communications with clinical trial sites, CROs, KOLs, and medical societies. It develops and manages a team that supports company clinical requirements in accordance with applicable guidelines and regulations, and anticipates challenges by developing methods to address them. As a functional manager, this position leads clinical operations personnel, including clinical study managers and clinical research associates, and supports their professional development. It works cross-functionally with Regulatory Affairs, R&D, PMO, CRE, clinical research managers, GAVE, GPA, Regulatory Compliance, Training, Legal, and commercial functions to optimize clinical study strategies and meet business objectives. The role manages study resources and budgets, oversees study quality and compliance, and helps deliver studies on schedule and within budget. Travel of up to 30–40% is required.

Requirements

Bachelor’s or master’s degree in a scientific field, or an MD or PhD, with 12+ years of professional experience.
At least 5 years of experience independently managing clinical studies through different phases, including pre-IDE, IDE submission, site selection and activation, study execution, data analysis and reporting, and closeout.
At least 3–5 years of supervisory experience is preferred.
Excellent clinical operations and project management skills, including experience collaborating with or leading cross-functional teams.
Proven record of cross-functional and key opinion leader management.
Strong experience managing clinical study resources and budgets.
Strong experience supporting clinical study scientific and regulatory strategy development.
Strong experience developing study 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, and interpersonal skills, with attention to detail and organization.
Results-driven attitude, strong problem-solving skills, and a strong work ethic to meet aggressive timelines or manage multiple projects when necessary.
Ability to travel up to 30–40%.

Nice To Haves

Previous experience supporting internal and external audits of clinical studies.
Comfort in a hospital environment and experience working with nurses and surgeons.
Existing or previous experience or familiarity with surgery or surgical technology.

Responsibilities

Contribute to the company’s clinical study strategy in support of business goals and objectives.
Collaborate with internal stakeholders and KOLs to develop and review study concepts, protocols, and study outlines, and drive identified initiatives.
Partner strategically with Regulatory Affairs to support regulatory approval of new products and contribute clinical sections to regulatory submissions.
Manage study resources and budgets to ensure studies are conducted on schedule, within budget, and with high quality and compliance.
Build and maintain relationships with investigational sites and investigators for current 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 such as GCP and U.S. FDA regulations and guidelines; review departmental procedures and lead process-improvement initiatives.
Set effective goals that benefit the department and organization.
Lead and develop direct reports, provide ongoing guidance, and support their communication and achievement of goals and objectives.
Set and uphold individual and team standards for competencies and performance; help the team prioritize and solve complex problems.
Develop a capable, effective team of clinical study managers and clinical research associates to manage clinical studies efficiently.
Travel up to 30–40%.