Principal Scientist Advanced Bionics

• 3.7 Valencia, CA Job Details $131,000
• $165,000 a year 9 hours ago Benefits Paid parental leave Paid holidays Disability insurance Health insurance Dental insurance Flexible spending account Tuition reimbursement Paid time off Parental leave Employee assistance program Vision insurance 401(k) matching Opportunities for advancement Qualifications Medical writing Clinical study protocols and reports Scientific and medical presentations experience Scientific research papers ICH guidelines Scientific protocols Compliance documentation Biomedical regulatory compliance Medical affairs Scientific reports Full Job Description 165193 Principal, Clinical Scientist Valencia, California•Hybrid Join Advanced Bionics as a Principal, Clinical Scientist and provide scientific leadership across global clinical development programs supporting innovative medical device technologies.

In this highly collaborative role, you will lead clinical study design, regulatory scientific strategy, evidence generation, and scientific communication across the product lifecycle to support regulatory approvals, indication expansions, and Medical Affairs initiatives. Responsibilities Lead the scientific design, development, and oversight of pivotal, post-market, investigator-sponsored, and real-world evidence studies from concept and protocol development through study completion and publication. Develop clinical study protocols, Clinical Study Reports (CSRs), literature reviews, and other essential clinical and regulatory documents supporting regulatory submissions. Lead scientific activities supporting regulatory submissions, including scientific justifications, responses to health-authority questions, and scientific interactions with regulatory agencies. Analyze and interpret clinical and scientific evidence to support clinical development, regulatory strategy, evidence generation, and product lifecycle management. Collaborate closely with Regulatory Affairs, Quality Assurance, R D, external experts, and other cross-functional partners to advance clinical development programs. Lead the development and review of scientific manuscripts, abstracts, posters, presentations, and other scientific publications. Support publication strategies, scientific training, congress presentations, and other activities that communicate and disseminate clinical evidence. More about you Master's degree in Life Sciences, Health Sciences, or another related scientific discipline. Minimum 8 years of experience in clinical development, clinical research, Medical Affairs, or Scientific Affairs, including protocol development and scientific writing. Demonstrated experience developing clinical study protocols, Clinical Study Reports, regulatory scientific documents, and scientific publications. Strong knowledge of

ICH-GCP, ISO 14155, FDA

regulations, and medical device clinical development. Excellent scientific writing, analytical, communication, presentation, and project-management skills. Ability to effectively collaborate across global and cross-functional teams and provide scientific leadership to complex programs. Ability to travel approximately 15-25% to scientific congresses, investigator meetings, and other study-related activities.

Preferred qualifications include:

a PhD or AuD; experience with Class III medical devices, hearing healthcare, or neuromodulation; experience leading cross-functional scientific initiatives or mentoring junior scientists; experience supporting

FDA PMA/IDE, EU

MDR, or other global regulatory submissions and health-authority interactions; and experience with reference-management and statistical software. A minimum of 300Mb/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 all in 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: $131K
• $165K.

This role is also [bonus eligible/commission eligible, if applicable]. 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. Sonova is an equal opportunity employer We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate's ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.