Senior Director, Clinical Affairs

Edwards Lifesciences Gruppe; Redhill (MD); On-site; USD 209,000 - 296,000; Full time

Job summary

Edwards Lifesciences is seeking a results-driven leader for its Clinical Affairs team in the United States. You will drive clinical strategy, oversee trial management, and coordinate with investigators, CROs, regulatory bodies and internal stakeholders to optimize patient outcomes and expand access to innovative therapies.

You will also lead talent development, ensure compliance with ICH/GCP, ISO14055, and CFR 820, and mentor a diverse, geographically distributed team while aligning activities

Qualifications

• Bachelor's Degree in a scientific field with clinical strategy experience.
• Proven leadership of diverse teams across geographies.
• Experience with Class II & III medical devices; ongoing clinical research education.
• Proven experience working with investigators, physicians and site study teams.

Responsibilities

• Direct clinical activities with responsibility for developing systems, planning, staffing and budgeting.
• Develop robust talent development and succession planning across the clinical organization.
• Oversee trial management, CRO staff and field clinical specialists on Edwards' research programs.
• Analyze and present recommendations to executive leadership; deliver executive communications.
• Mitigate risk and direct complex projects with internal/external negotiations.
• Plan and direct strategic activities to meet business objectives.
• Identify risk and develop mitigation strategies with cross-functional teams.
• Ensure on-time execution of clinical trials per global processes and regulations.
• Partner with internal teams to drive clinical trial success across functions.
• Provide strategic leadership including KOL relationships and scientific communications.

Skills

Clinical strategy

People management

Medical devices experience

Investigators collaboration

Regulatory knowledge

Data analysis

Executive communicatie

Education

Bachelor's Degree in scientific field

Job description

Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you will make an 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.
• Oversee the proper management and training of all trial management, CRO staff and field clinical specialists working on Edwards' research programs.
• 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.

What you will need (Required):

• Bachelor's Degree in 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 else we look for (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.
• Provide 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.
• Excellent financial and business acumen.
• 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.
• Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of clinical affairs to the business.
• Serves as core partner to senior leaders in Business Units, Functional Groups, and Regions.
• Understanding concepts of biostatistical and actuarial methods.
• Fully comply with all US and Global regulations, and SOPs in the execution of all job duties.
• 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 $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.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.