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Director, Clinical Research Scientist

8+ years
Not Disclosed
10 Nov. 28, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Opportunity: Director of Clinical Research Scientist
Location: Wilmington, DE
Employment Type: Contract

Proclinical is seeking a seasoned Director of Clinical Research Scientist to lead and support the Clinical Research team. This role offers a unique opportunity to work on innovative projects in a collaborative environment.

Primary Responsibilities:

  • Collaborate with physicians within Clinical Development to support clinical research programs.
  • Develop clinical study protocols and contribute to program strategy for assigned compounds/programs.
  • Draft and review clinical scientific documents, including INDs, Investigator Brochures, and Health Authority submissions.
  • Provide clinical input for eCRF design, statistical analysis plans (SAP), and tables, listings, and figures (TLFs).
  • Analyze and review study data with study team members, identifying trends and insights.
  • Represent Clinical Development on project teams and engage with external consultants for protocol feedback.
  • Lead the preparation of abstracts, posters, presentations, and manuscripts for study dissemination.
  • Collaborate with CROs, clinical sub-teams, and other stakeholders to ensure program success.
  • Stay updated on the competitive landscape and evolving standards of care in the industry.

Skills & Requirements:

  • A degree in a scientific or life sciences field is required; Pharm.D. or Ph.D. preferred.
  • At least 8 years of research experience, with 5+ years in drug development or relevant alternative experience.
  • Ability to manage multiple tasks in a fast-paced environment independently.
  • Exceptional written and oral communication skills.
  • Strong analytical abilities with a strategic mindset.
  • Willingness to travel up to 20% as required.

Key Deliverables:

  • Clinical study protocols
  • INDs, Investigator Brochures, and Health Authority submissions
  • Abstracts, posters, presentations, and manuscripts
  • Clinical input on study designs and deliverables

Contact Information:

For inquiries or to apply, please contact:
Mike Raletz
Email: m.raletz@proclinical.com

About Proclinical:

Proclinical is a leading recruitment firm specializing in pharmaceutical, biopharmaceutical, biotechnology, and medical device sectors. We are committed to diversity and inclusion and are proud to be an equal opportunity employer.

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