Senior Director, Clinical Trials & Medical Strategy

Edwards Lifesciences Gruppe; Redhill (MD); Presencial; USD 209.000 - 296.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Clinical strategy

People management

Medical devices experience

Investigators collaboration

Regulatory knowledge

Data analysis

Executive communicatie

Educación

Bachelor's Degree in scientific field

Descripción del empleo

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