Roche

Senior Clinical Research Scientist

Roche

full-time

Posted on:

Location Type: Hybrid

Location: Basel • 🇨🇭 Switzerland

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Lead the development of the clinical science aspects of the Clinical Development Plan strategy
  • Support various deliverables for effective CDP execution for the molecule/indication
  • Provide oversight of Medical Data Review Plan execution, database lock, data interpretation and CSR
  • Establish the clinical science strategy for CTA/EC submissions and other relevant documents
  • Act independently with investigators and oversight of investigator meetings
  • Contribute to Therapeutic Area Expert interactions to optimize clinical programs

Requirements

  • You hold a bachelor’s Degree (life sciences)
  • Advanced Clinical/Science Degree is highly preferred (e.g. PhD, PharmD, MSN, MPH, etc)
  • Extensive academic and/or industry experience, with a primary focus in late stage clinical development
  • Strong knowledge of medical aspects of GCP, ICH, FDA, EMA and other relevant guidelines and regulations
  • Experience leading and mentoring others
  • Demonstrated experience independently managing relationships with significant external partnerships/institutions
  • Ability to set out the strategy for trial/protocol development and context in the broader CDP
Benefits
  • Professional development opportunities
  • Flexible work arrangements
  • Health insurance

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
clinical development planmedical data reviewdata interpretationclinical trial applicationprotocol developmentdatabase lockclinical science strategyregulatory submissions
Soft skills
leadershipmentoringindependent managementrelationship managementstrategic planning
Certifications
PhDPharmDMSNMPH