Sr. Manager, Clinical Affairs – Emerging Technology

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of Position

As a Senior Manager of Clinical Affairs, this role is responsible for contributing to clinical strategies and overseeing study execution for emerging technologies across various specialties. Clinical trials in this portfolio may be both in the US and global and include first-human-use and pivotal clinical trials targeted for regulatory submission. This role will oversee and manages clinical protocols and other key study documents in assistance of regulatory submissions; manage clinical publications and evidence dissemination strategy, oversee manage communications with clinical trial sites, CROs, KOLs and medical societies; grow, develop and manage team to interface and help all clinical requirements of the company with the applicable guidelines and regulations; foresee challenges and develops critical concepts and methodologies to overcome those. As a functional manager, this role will also manage a team of clinical operations personnel, such as clinical study managers and clinical research associates and play a key role in their development.

As a key cross-functional constituent, this employee will work closely with functions across the organization – Regulatory Affairs, R&D, Program Management Office (PMO), Clinical Research Engineering (CRE), Clinical Research Managers, Global Access Value Economics (GAVE), Global Public Affairs (GPA), Regulatory Compliance, Training, Legal, and commercial functions to optimize clinical study strategies to meet business priorities.

Roles and Responsibilities

• Play a key role in the development of company’s strategy for clinical studies to meet business goals and priorities. Partner with internal stakeholders and KOLs to develop and review study concepts, protocol and study outlines and subsequently driving identified initiatives
• Acting as a key strategic partner to Regulatory Affairs to assist with regulatory approval of new products and contribute to clinical sections of regulatory submissions
• Responsible for managing resource and study budget to ensure clinical studies are conduced on schedule and within budget while ensuring high quality and compliance
• Build solid and sustaining relationship with investigational sites and investigators for ongoing and future studies
• Work closely with data management to provide guidance on development of case report form (CRF), data cleaning to ensure collection of high quality data
• Work closely with Biostats in study design, developing statistical analysis plan (SAP), insights, interpretation and synthesis in order to develop Clinical Study Report and /or assist with development of scientific publications
• Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US FDA regulations and guidelines) and responsible for ongoing review of departmental procedures and process improvement initiatives
• Responsible for setting up effective goals that are meaningful to the department and impactful to the organizations
• Provide functional manager leadership to direct reports and provide ongoing guidance for the assigned team members in their internal/external communication and assist direct reports in consistently achieving their goals and goals
• Sets and hold individual and team accountable for high standard of competencies and overall performance
• Effectively distills complexity and provides clear and actionable direction and information, help team prioritize, solve complex problems that enable the team to make significant progress
• Develop talents, build a highly capable and effective team of clinical study managers (CSM) and clinical research associates (CRA) to efficiently manage clinical studies

Qualifications

Skill/Job Requirements

Aptitude Requirements: (Skills is based on: education, training, skills and experience.)In order to adequately perform the responsibilities of this position the person must have:

• Minimum Education: Bachelor’s or Master's degree in scientific field/MD/ PhD with 12+ years of professional experience and at least 3-5 years of supervisory experience is preferred
• Minimum of 5 years of experience autonomously managing clinical studies through different study phases (pre-IDE, IDE submission, site selection and activation, study execution, data analysis and study report, and closeout)
• Excellent clinical operation and project management skills, with proven experience engaging or leading a cross-functional team
• Proven track record of exceptional cross-functional and key opinion leader management
• Solid experience with clinical study resource and budget management
• Excellent experience helping development of scientific and regulatory strategy for clinical studies
• Proven experience in developing study protocol and other study documents, conducting literature review, writing clinical section for regulatory submission
• Solid knowledge of 21 CFR part 812 , Good Clinical Practice, ISO14155 and other regulations/guidelines.
• Basic knowledge of statistics, statistical methods, and design of experiment
• Previous experience helping internal and external audit on clinical studies is preferred
• Excellent ability to interact with physicians and other professionals inside and outside the company
• At ease in a hospital environment, with experience working with nurses and surgeons; existing or previous experience/familiarity with surgery/surgical technology is preferred
• Exceptional communication, presentation and relational skills with high attention to detail and organization
• Results-driven attitude and exceptional problem solving skills, consistently shows dedication or exceptional work-ethic to help meet fast-paced timelines or multiple projects when necessary
• Must be able to travel up to 30-40%

Additional Information

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 Employment 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.

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

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 salary ranges are listed.

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

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 salary ranges are listed.