Senior Director, Medical Affairs (Irvine, CA / Remote, USA), Transcatheter Heart Valve

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring, with a rapidly growing portfolio of innovative and less invasive solutions.

The mission of the Transcatheter Heart Valve (THV) Medical Affairs organization is to foster internal and external collaborations to generate and disseminate evidence-based best clinical practices to help save patients’ lives and advance quality of care. Our work evolves around four pillars:

• Clinical Evidence Generation
• Clinical Data and Best Practice Dissemination to Physicians
• Physicians hands-on Training and Support
• New Product Testing & Expanded Indications
  
  

We have an exceptional leadership role in THV’s Medical Affairs organization. The Senior Director, Medical Affairs will be the subject matter expert for physician education and training, external KOL relationships, and therapy and procedure development, as well as the execution of assigned medical affairs activities.

This role can be based at Edwards’ corporate headquarters in the US or can be a remote-based role in the US.

Key Responsibilities:

• Lead physician education, training, and relations, including supervision of Proctor Program team
• Lead imaging development program
• Lead and participate in regular meetings on therapy and procedure development
• Work with marketing and sales on therapy development
• Analyze and present strategic recommendations with advisory boards, clinicians, and key opinion leaders to address medical education and clinical practice dissemination needs
• Serve as an advisory role for senior/executive management and deliver executive communication on technical subject matter expertise to internal leadership team
• Provide input to cross-functional teams (e.g., Regulatory Affairs, Safety, Scientific Communications, Clinical Affairs, R&D) to influence policies and strategic direction for the business unit
• Develop a robust talent development plan in alignment with functional growth strategies of the department
• Identify risk, develop, and lead in the implementation of broad and more complex cross-functional Medical Affairs (Clinical Research Studies, Scientific Communication, Medical Information Processes, Educational grants, Medical Educations) strategies which may include negotiations with internal and external parties and cross-functional teams
• Build strong, sustainable working relationships with physician key opinion leaders
• 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, etc. in collaboration with cross-functional and/or matrix teams
• Create and maintain metrics on key business processes to monitor physician training and professional education programs
  
  

Minimum Requirements:

• PhD/MD and 10 years of medical affairs and/or physician training, clinical marketing or scientific clinical research related experience within the medical device or pharmaceutical industry
  
  

OR

• Master’s degree in scientific or related discipline and 12 years of medical affairs and/or physician training, clinical marketing or scientific clinical research related experience within the medical device or pharmaceutical industry
  
  

OR

• Bachelor’s degree in scientific or related discipline and 14 years of medical affairs and/or physician training, clinical marketing or scientific clinical research related experience within the medical device or pharmaceutical industry
  
  

AND

• Demonstrated track record in people management
• Ability to travel up to 30%-50% globally/domestically for training programs, conferences and site visits, as needed
  
  

Preferred Qualifications:

• Cardiovascular medical device industry experience
• Experience in a similar role within the medical device or pharmaceutical industry
• Clinical Knowledge in the interventional cardiology space
• Knowledge and understanding of policies, procedures and guidelines related to clinical research and scientific communications.
  
  

Additional Skills and General Expectations:

• Proven track record in developing and maintaining relationships with internal and external stakeholders
• Proven successful project management leadership skills
• 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 ability to drive achievement of objectives
• Proficient in Microsoft Office Suite and related tools and systems
• Expert understanding of business strategy, competitive landscape, regulatory environment, and clinical data with extensive and detailed knowledge of company allowing for innovative concepts and promoting new ideas
• 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 medical affairs to the business
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to work and excel within a fast-paced, dynamic, and constantly changing work environment
• Dedicated to quality client service and pro-active and responsive to client needs
• Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness
• Support and solicit input from team members at all levels within the organization
  
  

For Colorado Residents Only:

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.

The base pay range for this position is $218,000 to $255,000.

Additional information can be found through the link below:

https://www.edwards.com/careers/benefits

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.