Senior Director, Clinical Affairs

What You Will Need

• Bachelor's Degree in scientific or related discipline with related experience including clinical strategy
• Demonstrated track record in people management with ability to effectively lead and manage a diverse team across multiple geographies
• Experience with Class II & III medical devices preferred, documented current continuing education in clinical research monitoring or experience in Clinical Research
• Proven experience in effectively working with Investigators, physicians and site study teams

What You Will Need (Preferred)

• Relevant clinical trial experience in heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure areas strongly preferred
• Experience in managing Pivotal and Post Approval clinical trials in the US and Europe
• Experience in clinical, regulatory and marketing aspects of medical device technology
• Experience providing leadership and direction to large cross-functional teams to successfully implement global enterprise systems and related solutions
• Proven successful project management leadership skills with ability to meet deadlines on multiple projects
• Expert understanding of clinical regulations/guidelines and procedures (e.g., ICH/GCP E6, ISO14155, CFR 820, Canadian Medical Device Regulation (CMDR), EU MDD/MDR) while looking beyond existing methodologies and own discipline to define and resolve complex problems
• Expert understanding and application of industry best practices
• Demonstrated ability to direct teams 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
• Developing and integrating metrics into the projects and operations that clearly demonstrate the value of clinical affairs to the business
• Serving as core partner to senior leaders in Business Units, Functional Groups, and Regions
• Understanding concepts of biostatistical and actuarial methods

What You Will Impact

• Direct clinical activities with overall responsibility of developing systems, planning, staffing, budgeting, managing expense priorities, recommending and implementing changes to methods through manager(s) and/or experienced professionals
• Develop a robust talent development and succession planning in alignment with functional growth strategies across the clinical organization
• Analyze, formulate and present recommendations to advise and guide executive level leadership; develop and deliver executive level communication
• Mitigate/eliminate risk, direct and communicate highly complex projects, initiatives and/or strategies which includes negotiations with internal and external parties
• Plan and direct strategic activities including prioritizing and selecting appropriate projects with overall responsibility for meeting business objectives
• Lead in identifying risk, developing complex mitigation strategies, best practices, alternative solutions, resolving issues, etc. in collaboration with cross functional and/or matrix teams including but not limited to:
• Ensure on time execution of clinical trials in accordance with global clinical processes, regulations and good clinical practices
• Effectively partner with internal team members to drive clinical trial success across multiple functions
• Provide strategic leadership and direction including the development and maintenance of significant KOL relationships
• Key stakeholder in Scientific Communication activities: clinical data reports, presentations for Regulatory submissions, conferences and study meetings (e.g., Executive Committees, DSMB, CEC, Steering Committees) and ensure accuracy and relevancy

Pay and Benefits

For California, the base pay range for this position is $209,000 - $296,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Applications will be accepted while this position is posted on our Careers website.

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