Director, Clinical Trial Patient Screening & Core Lab Management (California Hybrid) TMTT

Have you been searching for a role that brings you to the forefront of innovation? We have an outstanding leadership opportunity for you to join an early-stage medical device team boldly designing transcatheter mitral and tricuspid therapies from the ground up!

The Transcatheter Mitral and Tricuspid Therapies (TMTT) division is passionate about developing breakthrough solutions for patients suffering from structural heart disease. Join this rapidly growing, fast paced, dynamic team - and play a pivotal role in managing Edwards Lifesciences sponsored clinical studies, bringing new medical devices from concept to commercialization.

As the Director, Clinical Trial Screening & Core Lab Management, you will manage a team of clinical patient screening managers and clinical analysts dedicated to guiding the process of patient selection for clinical trials.

Key Responsibilities including but not limited to:

• Lead Clinical Patient Screening team including management oversight, mentoring, guidance to drive processes and excellence to support global clinical studies and business initiatives.
• Oversee primary leads of multiple clinical trials, including developing global cross-functional protocols
• Manage relationships with multiple Core Labs, partner to analyze radiologic trial data to support patient eligibility and study endpoints
• Plan, oversee, and lead in the development of procedures and supportive training materials (e.g., work instruction, slide deck) that guide clinical patient screening processes
• Anticipate future needs and oversee the development of content and present trial data and protocol reviews externally (e.g., trial meetings and conferences) in collaboration with physicians and KOLs and present to internal stakeholders (e.g., executive and department team meetings)
• Plan and direct complex activities with large scale or significant business impact with the accountability for successful completion of all deliverables. Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues in collaboration with cross functional and/or matrix teams
  
  

Minimum Qualifications

• Bachelor’s or equivalent four (4) year degree
• Experience with Clinical Patient Screening, Clinical Trial Management, Clinical Project Management or Clinical Research experience obtained from medical device / pharmaceutical / biotech, CRO, or hospital industries
• Demonstrated track record of people management experience and strong leadership and coaching ability
  
  

Preferred Qualifications

• Strong knowledge of Cardiovascular Physiology and structural heart anatomy
• Prior clinical research experience within Medical Devices including PMA, IDE, 510k
  
  

Additional Talents And General Expectations

• Proven successful project management leadership skills
• Proven expertise in Microsoft Office Suite and related tools and systems
• Excellent problem-solving, organizational, analytical, and critical thinking skills including high discretion/judgment in decision making
• Excellent written and verbal communication skills and interpersonal relationship skills, including negotiating and relationship management skills with the ability to drive achievement of objectives
• Understanding of clinical procedures while addressing issues with impact beyond own team based on knowledge of related disciplines
• Understanding of associated aspects of clinical patient screening processes and/or systems
• Demonstrated ability to manage a team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
• Ability to develop and integrate metrics into the projects and operations that demonstrate the value of clinical patient screening to the business
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to work and excel within a fast-paced, dynamic, and continually changing work environment
  
  

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $153,000 to $218,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.