Principal Clinical Scientist: Evidence & Regulatory

Sonova Group; Santa Clarita (CA); Hybrid; USD 131.000 - 165.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision coverage

401k plan with company match

Life/AD&D insurance

Zusammenfassung

Advanced Bionics, a Sonova Group company, in Valencia, CA, seeks a Principal, Clinical Scientist to lead clinical study design, regulatory strategy, evidence generation, and scientific communication across the product lifecycle to support approvals and indications.

The role requires a Master’s in Life Sciences with 8+ years in clinical development, strong ICH-GCP/FDA knowledge, and excellent scientific writing. Hybrid work, ~15–25% travel, and strong growth opportunities are offered.

Qualifikationen

• Master's degree in Life Sciences, Health Sciences, or related field.
• 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, CSRs, regulatory documents, and 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 collaborate across global, cross-functional teams and provide scientific leadership.
• Ability to travel ~15–25% to congresses, investigator meetings, and study activities.

Aufgaben

• Lead design, development, and oversight of pivotal, post-market, investigator-sponsored, and real-world evidence studies.
• Develop clinical study protocols, CSRs, literature reviews, and regulatory documents.
• Lead activities supporting regulatory submissions and health-authority interactions.
• Analyze and interpret clinical evidence to support development, regulatory strategy, and lifecycle management.
• Collaborate with Regulatory, QA, R&D, externals to advance programs.
• Lead development and review of manuscripts, abstracts, posters, and publications.
• Support publication strategies, training, congress presentations, and dissemination of evidence.

Kenntnisse

8+ years clinical development

Scientific writing

Regulatory thinking

Cross-functional collaboration

Communication skills

Project management

Travel readiness

Ausbildung

Master's degree in Life Sciences/Health Sciences

Tools

Reference-management software

Statistical software

Jobbeschreibung

Advanced Bionics, a Sonova Group company, in Valencia, CA, seeks a Principal, Clinical Scientist to lead clinical study design, regulatory strategy, evidence generation, and scientific communication across the product lifecycle to support approvals and indications.

The role requires a Master’s in Life Sciences with 8+ years in clinical development, strong ICH-GCP/FDA knowledge, and excellent scientific writing. Hybrid work, ~15–25% travel, and strong growth opportunities are offered.