Director, Clinical Development Scientist - Remote

Overview

The Director, Clinical Development Scientist will be the clinical and medical primary lead to support the APAC region for our lead program, Myasthenia Gravis (gMG).

In Short

• Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project.
• Leading development of clinical sections of trial and program level regulatory documents.
• Driving execution of the program and/or clinical trial in partnership.
• Supporting the Clinical Development program lead by providing medical input into Clinical Development Plan (CDP).
• Literature review and KOL interactions.
• Leading the protocol development for new indications.
• Medical monitoring of assigned clinical trials.
• Working closely with internal and external stakeholders.

Requirements

• MD, PhD, or PharmD required.
• Experience in clinical development required.
• Experience in rare diseases, neurology highly preferred.
• Strong business communication skills.
• Thorough understanding of GCP/regulatory requirements.
• Ability to identify challenges and risks.
• Highly motivated and self-starter.
• Collaboration skills with cross-functional teams.
• Open-mindedness and willingness to seek guidance.

Benefits

• Opportunity to join a growing organization.
• Lead clinical strategy for auto-immune neurology indications.
• Work remotely.