Senior Clinical Scientist - Growing Biotech

Highly Competitive
  1. Permanent
  2. Clinical Scientist
  3. Netherlands
Leiden, Nederland
Posting date: 26 Mar 2024

Job Title: Senior Clinical Scientist - Permanent Position. Growing Biotech.
Location: Leiden, NL (on-site)

Job Description:
Proclinical is seeking a Senior Clinical Scientist to join our team. This role is integral to our development organization as we prepare to start clinical development of our Axiomer pipeline. The successful candidate will lead the scientific and operational elements of the Clinical Development Plan for one of our pipeline projects, focusing particularly on cholestatic liver diseases. This role requires a proactive leader who can navigate the complexities of early clinical stage programs.

Key Responsibilities:
- Crafting detailed protocols and defining innovative endpoints.
- Leading robust data analysis and statistical evaluation.
- Acting as the primary scientific contact for study sites, vendors, operational teams, and management.
- Building and maintaining relationships with Key Opinion Leaders (KOLs) and external studies.
- Staying abreast of the scientific, competitive, and regulatory landscapes.
- Ensuring study plans and reports are compliant with GCP and adverse events are appropriately reported.
- Writing and reviewing clinical and regulatory documents to support clinical development of lead compound(s).

- An advanced degree (PhD/MSc) in a Life Science or Applied Science discipline.
- Experience in liver and cardiovascular diseases, with prior experience in cholestatic disease and rare disease drug development being an advantage.
- 5-10 years experience in various facets of research & development including clinical operations, and clinical development.
- Excellent knowledge of GCP, clinical operations, clinical trials, translation from pre-clinical to phase 1, scientific methodology, data analyses and basic statistics.
- Experience working in multiple Phases of drug development, specifically early phases of clinical development (i.e., phase 1-2) and writing clinical documents for regulatory submissions.
- Knowledgeable about the scientific, competitive and evolving drug development environment.
- The ability to work independently and in a matrix setting.
- Excellent written and oral communication, strategic & creative thinking, decision making and problem solving skills.
- Cross functional / matrix leadership skills and strong project planning and management skills.
- Being able to work in a fast pace environment.

About Proclinical:
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