Senior Manager, Clinical Affairs

Intuitive•Sunnyvale, CA

About The 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 support 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 support 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 lead 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 objectives.

Requirements

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 independently 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 strong experience collaborating or leading a cross-functional team
Proven track record of strong cross-functional and key opinion leader management
Strong experience with clinical study resource and budget management
Strong experience supporting development of scientific and regulatory strategy for clinical studies
Strong experience in developing study protocol and other study documents, conducting literature review, writing clinical section for regulatory submission
Strong knowledge of 21 CFR part 812 , Good Clinical Practice, ISO14155 and other regulations/guidelines.
Basic understanding of statistics, statistical methods, and design of experiment
Previous experience supporting internal and external audit on clinical studies is preferred
Excellent ability to interact with physicians and other professionals inside and outside the company
Comfortable in a hospital environment, with experience working with nurses and surgeons; existing or previous experience/familiarity with surgery/surgical technology is preferred
Strong communication, presentation and interpersonal skills with high attention to detail and organization
Results-driven attitude and strong problem solving skills, consistently shows dedication or strong work-ethic to help meet aggressive timelines or multiple projects when necessary
Must be able to travel up to 30-40%

Responsibilities

Play a key role in the development of company’s strategy for clinical studies to meet business goals and objectives.
Collaborate 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 support 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 strong 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), analysis, interpretation and synthesis in order to develop Clinical Study Report and /or support 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 support direct reports in consistently achieving their goals and objectives
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