Director Clinical Affairs Information Management

This role is responsible for creating the vision, strategy and plans that guide the work of
multiple teams and effectively integrates multidisciplinary strategies to enable seamless
execution of various initiatives. The role will manage Data Management, Clinical
Systems and Biostatistics functions globally within the Clinical Affairs department. The
role balances technical expertise, strategic planning, team leadership and cross-
functional collaborations.
The data management responsibilities include overseeing data collection, management
and quality control for clinical data. Clinical systems responsibilities include overseeing
clinical technology, managing the implementation, validation and optimization of all
clinical systems in collaboration with IT department. Biostatistics responsibilities include leading design, analysis, and interpretation of data for clinical investigations while
ensuring all activities meet regulatory and scientific standards.
 

Database Management:

• Lead in lifecycle management of clinical study data collection, validation, reporting specification and usage process and guidelines.
• Oversee the development and implementation of data management plans, data collection strategies, and quality control procedures to ensure data accuracy and integrity.
• Collaborate with other teams, such as clinical operations and biostatistics, to align data management activities with overall research objectives.
• Utilize industry expertise in managing the maintenance and development of departmental operating processes (WI/DOP) for data management.
• Partner with external service providers (CROs, EDC vendors) to meet business goals.
• Proactive in understanding and assessing company needs/objectives through effective communication across multiple organizations. Works on significant and unique issues in critical situations and takes the lead in recommending solutions.

Biostatistics:

• Provide scientific and statistical expertise to drive development and life cycle management strategies. 
• Oversee the statistical design, and analyses for all phases/types of clinical investigations.
• Lead the strategy and implementation of publication-level and regulatory-level statistical programming in R, SAS, and/or Python.
• Adherence to international best practices for medical device clinical trial design, analysis, programming, and reporting.
• Develop and implement biostatistics department policies, standards, practices, and work-instructions in coordination with multiple stakeholders.

Clinical Studies Management Systems (Clinical Systems):

• Lead the implementation, management, and optimization of clinical technology solutions.
• Drive improvements in patient care and outcomes through effective use of clinical systems.
• Work with the IT department to ensure necessary corporate system support needed for clinical systems. This could include the creation of connectivity to other systems such as payments or other aspects of inventory management in the future.
• Manage system upgrades, implementation projects, and vendor relationships.
• Oversee the administration and maintenance of clinical systems at department level. This will include periodic reviews and validations as tools evolve over time.

Overall management responsibilities:

• Overall responsible for educating others on best practices and help develop guidelines.
• Establish departmental goals, managing progress and resources to ensure on-time and on-target results.
• Responsible for managing budgets and other resources in a consistently effective and efficient manner.
• Involved in developing, modifying, and executing company policies that affect immediate operations and may also have companywide effect.
• Successfully leading multiple teams or functions, effectively leads and develops others in applicable discipline(s). Routinely leads complex projects/initiatives.
• Effectively takes a short- and long-range approach to achieving results. Ensures the function and team consistently meets its targets, goals, and objectives, while keeping an eye on the future and how current results affect and support future needs and evolutions.
• Effectively integrates communications across multiple teams and activities for cohesive and unified messaging within teams and across Intuitive

Required Skills and Experience:

• 15+ years of experience in managing clinical database needs, clinical information science management and biostatistics.
• 5-7+ years of supervisory experience. Must have proven ability to develop and mentor employees and have meaningful performance conversations.
• Deep understanding of clinical technology solutions and systems, database management, and statistical analysis tools is essential.
• Experience of successful interactions with regulatory authorities, scientific congresses and peer reviewed journals.
• Good understanding of computer validation process in GxP environment.

Required Education and Training:

• Bachelor’s degree in life sciences, statistics or equivalent. Master’s level education desirable/preferred.
• Ability to oversee and influence groups, along with managing multiple projects and tasks independently.
• Must be clinically savvy and be able to bridge clinical message and analytics.
• Must have good organizational skills and be able to handle multiple projects simultaneously.
• Ability to think strategically, be resourceful, and lead without formal authority
• Excellent verbal/written communication, teamwork, and interpersonal skills are necessary to work across multiple constituents. This role requires the ability to create executive summaries and deliver polished presentations in a clear and digestible manner.
• Travel will be required for this role 5-10% to oversee global responsibilities

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.

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.