Director of Clinical

Description

We are seeking a Director of Clinical to join our growing team. Reporting directly to the Chief Regulatory Officer, you will be responsible for the management, oversight, and hands-on execution of clinical programs ensuring they are completed according to timelines, budgets, and regulatory and corporate quality standards. This person will serve as a functional leader and subject matter expert. They will work collaboratively with other functional leads in the achievement of departmental and corporate objectives and initiatives. With extensive industry knowledge and experience, the candidate will proactively seek to improve the efficiency, effectiveness, and quality of EBR’s clinical activities. This is an exciting time to join our fabulous team.

This is a hybrid position in Sunnyvale, CA. The typical week will require 3 days/week onsite, or more during peak times. Local candidates are preferred.

Summary of what you will do:

• Lead constructive interactions with clinical sites to ensure that all trials and programs have clearly defined plans, strategies, and milestones.
• Oversee and develop clinical operations strategy to meet corporate goals and satisfy needs of multiple stakeholders, such as regulatory agencies, corelabs, DSMB, payors, hospitals, and patients. 
• Facilitate meetings with health care professionals for Investigator Meetings, Clinical Events Committees, Advisory Boards / Steering Committees, and Publication Committees. 
• Help develop and execute clinical trials, case series and other studies in collaboration with relevant cross-functional disciplines and ensure implementation with a team of clinical affairs professionals. 
• Assume overall responsibility for the development and amendment of protocols and Case Report Forms, finalization of monitoring and data management options (either in-house or contracted to a Contract Research Organization), Ethics committee approval, development of recruitment strategies to increase patient enrollment into the trial, the provision of clinical trial materials, and management of the trial. 
• Develop budget and manage spending. Have responsibility for the financial management of the clinical trial program including budget planning, resource allocation and preparation of any required reports. 
• Recruit, hire and manage staff. Responsible for identifying training needs, coaching of direct reports and staff (such as CRAs) in relevant to job function and specific projects. 
• Draft and finalize publications, study reports, and annual reports as needed. 
• Liaise with Clinical-Marketing function to disseminate study data and meet publication schedules. 

Requirements

Education & Experience:

• Bachelor’s degree in a scientific field or equivalent experience. Advanced degree preferred. GCP Trained and Qualified 
• 10 years of experience in clinical research --working in a hospital/clinic, MedTech, or CRO (active implantable cardiovascular device experience preferred) Experience with US, CE, and other international regulations for medical devices, including regulatory support for movement of devices across geographies.

Qualifications: 

• Advanced expertise in all aspects of Clinical Operations with clear understanding of GCP practices, strategies, PI management, as relates to the EBR’s technology. 
• EBR, CEC, DSMB, and Steering Committee Support and Management.
• Experience with Active Implantable Medical Device product trials and regulations. 
• Significant knowledge of clinical and outcomes research study design. 
• Ability to recruit, train, and mentor Clinical RA and Study Managers.
• CRO and vendor management expertise. Ability to develop and maintain excellent relationships with Site Study coordinators and Core Labs.
• Excellent communication and interpersonal skills with demonstrated ability to maintain ongoing communications with field operations. 
• Personal attributes: independent, decisive, accurate, detail-oriented, organized, and flexible with a positive team-oriented attitude. 
• High attention to detail and accuracy. Proficient knowledge of medical terminology. 
• Must have strong interpersonal, communication, and organization skills.
• Must be willing and able to travel 25% of the time as required.

Salary Range:

$170,000 - $230,000

Base pay is one part of your total compensation. The final starting salary offer to the successful candidate will be determined by evaluating several factors, such as education, experience, knowledge, skills, internal equity, and alignment with market data. 

About EBR Systems

Silicon Valley-based EBR Systems is dedicated to superior treatment of cardiac rhythm disease by providing more physiologically effective stimulation through wireless cardiac pacing. The company’s patented proprietary Wireless Stimulation Endocardially (WiSE TM) technology was developed to eliminate the need for cardiac pacing leads, historically the major source of complications and reliability issues in cardiac rhythm disease management. 

We are a team of dedicated individuals, driven to deliver superior treatment to millions of patients suffering from cardiac rhythm diseases by developing safe, clinically superior, cost-effective, and reliable therapies using wireless cardiac stimulation. 

As a fast-paced company, every team member at EBR makes important contributions toward our mission. We seek candidates who are passionate about improving healthcare and motivated to do the hard and exciting work required to bring a ground-breaking technology to market.

EBR Systems offers a great place to work as well as generous benefits and growth opportunities:

• Medical, dental, vision
• Life, Long-term disability, and AD&D insurance
• 401K
• PTO – starting at 3 weeks per year
• Competitive salary with opportunities for career growth