2 дня назад
Principal Clinical Scientist (Neurodegenerative)
120 000 - 130 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Principal Clinical Scientist (Neurodegenerative) (Diagnostics/Clinical Research): Designing clinical trial strategies and evidence plans for neurodegenerative diagnostic products across US and EU markets with an accent on study design, regulatory compliance, and scientific interpretation. Focus on developing protocols and claims, supporting FDA 510(k)/PMA and CE-IVDR submissions, and coordinating complex cross-functional clinical programs.
Location: Remote-based in the United States, with an onsite option in Chaska, Minnesota
Annual salary: $120,000–$130,000, plus bonus or incentive pay
Company
develops life sciences, diagnostics, and biotechnology solutions, including connected diagnostic technologies for hospitals, clinics, and research partners.
What you will do
- Design clinical studies and evidence strategies for global regulatory submissions across diagnostic modalities.
- Develop study protocols, claims, and evidence plans with regulatory bodies, key opinion leaders, and external clinical sites.
- Partner with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams to align clinical programs with product development and market access.
- Author and review clinical and regulatory documentation, including study reports, technical files, and publications.
- Build internal and external collaborations, mentor junior scientists, and monitor evolving clinical guidelines, regulatory standards, and diagnostic technologies.
Requirements
- Bachelor’s degree in Life Sciences, Healthcare, or a related field with 9+ years of relevant clinical research experience; alternatively, a Master’s degree with 12+ years or a Doctoral degree with 4+ years.
- Significant experience with clinical trials in the US and/or EU.
- In-depth knowledge of clinical study design and methodology in diagnostics, medical devices, or pharmaceuticals intended for US and EU markets.
- Ability to solve complex clinical trial issues and critically interpret scientific and clinical data.
- Strong written, verbal, and interpersonal communication skills.
Nice to have
- Experience designing studies for IVD technologies, particularly neurodegenerative biomarkers.
- Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs.
- Professional clinical research certification such as SoCRA or ACRP.
Culture & Benefits
- Flexible remote working arrangement for eligible employees.
- Medical, dental, and vision insurance.
- Paid time off.
- 401(k) benefits for eligible employees.
- Bonus or incentive pay eligibility.
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