Lead Clinical Scientist, Diagnostics (Remote)

Beckman Coulter Diagnostics

Las Vegas (NV)

À distance

USD 120 000 - 130 000

Plein temps

Il y a 2 jours
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Avantages offerts par ce poste

Remote work
Bonus eligibility
Medical/dental/vision insurance
401(k) plan
Paid time off

Résumé du poste

Beckman Coulter Diagnostics seeks a Principal Clinical Scientist to lead clinical trial strategies for US and EU regions, supporting regulatory submissions and ensuring compliance. The role may be remote or onsite, operating within the Danaher Diagnostics framework.

You will design studies, liaise with regulators and key opinion leaders, and collaborate with R&D, Medical Affairs, and Quality teams to align clinical programs with product development and market access needs.

Qualifications

  • Bachelor’s degree in Life Sciences or related field with 9+ years of clinical research experience.
  • In-depth understanding of US/EU trial design and regulatory requirements.
  • Strong communication and cross-functional collaboration skills.
  • Experience with regulatory submissions (FDA/CE) preferred.

Responsabilités

  • Design clinical studies and evidence strategies for regulatory submissions.
  • Coordinate with regulatory bodies, KOLs, and external sites.
  • Collaborate with R&D, Regulatory, Medical Affairs, and QA teams.
  • Prepare reports, technical files, and publications.
  • Mentor junior scientists and stay current with regulatory guidelines.

Connaissances

Clinical trial design
Regulatory compliance
Regulatory liaison
Communication skills
Cross-functional collaboration

Formation

Bachelor’s degree Life Sciences (or related)
Master’s degree or Doctoral degree (optional)

Description du poste

Beckman Coulter Diagnostics seeks a Principal Clinical Scientist to lead clinical trial strategies for US and EU regions, supporting regulatory submissions and ensuring compliance. The role may be remote or onsite, operating within the Danaher Diagnostics framework.

You will design studies, liaise with regulators and key opinion leaders, and collaborate with R&D, Medical Affairs, and Quality teams to align clinical programs with product development and market access needs.

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