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Clinical Development Lead at Roche - ApplyBlast

Clinical Development Lead

Roche

3 months ago

4.1 on Glassdoor

Tucson, Arizona

Hybrid

Full Time

Senior

0 applicants

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About this role

The Clinical Development Lead at Roche Diagnostics serves as a strategic partner within the Clinical Evidence team, focusing on designing scientifically sound clinical studies and generating documentation for In Vitro Diagnostics (IVD) registration. This role involves creating protocols, reports, and regulatory submissions while collaborating with subject matter experts to support new product development and compliance. The position also includes overseeing the document lifecycle, providing scientific input for regulatory agencies, and mentoring less experienced team members.

Responsibilities

Design scientifically sound clinical studies for new product development
Create and review clinical study protocols and reports
Provide medical input for regulatory submissions and agency responses
Oversee the entire document lifecycle ensuring compliance and quality
Mentor less experienced team members and foster continuous improvement

Skills

Qualifications

Doctoral degree in life sciences, pharmacology, or related fieldPhD, MD, or PharmD5+ years of scientific research experienceProven scientific writing experience in clinical or regulatory documentsExperience with regulatory writing for in vitro diagnostics

About Roche

roche.com

Headquarters

Basel, Basel-Stadt, Switzerland

Company Size

10001+ employees

Founded

1896

View Profile

As a pioneer in healthcare, we have been committed to improving lives since the company was founded in 1896 in Basel, Switzerland. Today, Roche creates innovative medicines and diagnostic tests that help millions of patients globally.