Principal Scientist

About the role

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.

Requirements

• 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.
• A minimum of 300Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality.

Preferred Qualifications

• 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.
• Experience with reference-management and statistical software.

Benefits

• 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.

Pay

This role's pay range is between $131K – $165K. This role is also bonus eligible.

Schedule

Hybrid work model with team-customized flexibility to balance individual needs with business goals.