Sr. Director, Global Clinical Affairs & Medical Affairs

Valencia, CA - Hybrid

Senior Director, Global Clinical Affairs & Medical Affairs

The Sr. Director, Global Clinical and Medical Affairs, is responsible for leading the planning and execution of clinical research and medical affairs programs to support regulatory approval, market access, and product life-cycle initiatives for Advanced Bionics' portfolio of Class III medical devices. This role supports global clinical and medical strategy and ensures the timely and compliant execution of clinical trials and dissemination of clinical data, with a focus on collaboration, innovation, and operational excellence.

Responsibilities:

• Lead the development and execution of global clinical research strategies to support regulatory submissions, market access, and product lifecycle initiatives, including pivotal, pre-launch, and post-market studies.
• Set direction and ensure alignment of clinical research priorities with company objectives, ensuring timely delivery of impactful clinical evidence.
• Provide strategic oversight of global clinical operations, ensuring trial execution meets regulatory, ethical, and quality standards across regions.
• Cultivate and sustain high-impact relationships with Key Opinion Leaders (KOLs), investigators, and key external stakeholders to support study execution and enhance market readiness.
• Partner cross-functionally with R&D, Regulatory, Quality, and Commercial teams to translate clinical insights into product development and go-to-market strategies.
• Shape medical communication strategies by guiding the development of educational materials, publications, and evidence-based messaging that reinforce the clinical value proposition.
• Develop and lead high-performing teams, fostering a culture of accountability, innovation, and continuous learning through mentorship, coaching, and professional development planning.
• Oversee the design and refinement of study protocols, risk management plans, and monitoring strategies, ensuring operational feasibility and regulatory compliance.
• Collaborate with global regulatory and quality teams to align clinical strategy with evolving regulatory pathways and support successful global submissions.
• Champion operational excellence through continuous improvement, driving efficiencies in clinical execution, resource management, and data dissemination.
• Other duties as assigned.

Additional Key Responsibilities

• Monitor and report on the progress of projects.
• Manage budgets and resources.
• Ensure timely submission of clinical trial data to regulatory authorities.
• Identify and mitigate risks associated with clinical research and medical affairs activities.
• Provide medical input for marketing and promotional materials to ensure accuracy and compliance.
• Support the development of reimbursement strategies and health economics studies.
• Drive continuous improvement in clinical research and medical affairs processes.

More about you:

• Bachelor's degree in a relevant field (e.g., Life Sciences, Medicine, Biomedical Engineering).
• Nice to have: Advanced degree (e.g., Master's, PhD) in a related field.
• Ongoing professional development in clinical research, medical affairs and regulatory affairs.

• Nice to have: Certifications in clinical research and medical affairs (e.g., CCRP, CCRA, MSL).

• 10+ years of progressive experience in clinical research, with at least 5 years in a senior leadership role.
• Nice to have: Experience in the Class III medical device sector is strongly preferred
• Fluent in English

• Nice to have: Proficiency in additional languages relevant to global operations.
• Proficiency in clinical trial management systems and software and data analysis tools

• Nice to have: Advanced skills in data analysis tools and software.

• Willingness to travel internationally.
• Commitment to ethical standards and practices.

A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova

Don't meet all the criteria? If you're willing to go allin and learn we'd love to hear from you!

We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered. Sonova does not recruit via app, telegram, carrier pigeon or any other format that does not include speaking with an actual human. If you are offered a job without speaking with someone please contact Sonova Human Resources

What we offer:

• Medical, dental and vision coverage*
• Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
• TeleHealth options
• 401k plan with company match*
• Company paid life/ad&d insurance
  
  
  
  • Additional supplemental life/ad&d coverage available
  
  
  
  
• Company paid Short/Long-Term Disability coverage (STD/LTD)
  
  
  
  • STD LTD Buy-ups available
  
  
  
  
• Accident/Hospital Indemnity coverage
• Legal/ID Theft Assistance
• PTO (or sick and vacation time), floating Diversity Day, & paid holidays*
• Paid parental bonding leave
• Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more)
• Robust Internal Career Growth opportunities
• Tuition reimbursement
• Hearing aid discount for employees and family
• Internal social recognition platform

*Plan rules/offerings dependent upon group Company/location.

This role's pay range is between $160,680/yr - $241,020/yr. This role is also bonus eligible.

How we work:

At Sonova, we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team-customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.