Director, Clinical Scientist

Director, Clinical Scientist – CNS

Overview

A biotechnology company seeks an experienced clinical scientist to drive CNS therapeutic development. This role involves collaborating with clinical teams, ensuring scientific integrity in trials, and engaging with regulatory authorities, strategic partners, and advocacy groups.

Key Responsibilities

• Develop clinical development plans, protocols, and regulatory documents.
• Support regulatory submissions and respond to inquiries.
• Ensure study design quality, compliance with GCP, and data integrity.
• Plan investigator meetings, oversee trial execution, and analyze data.
• Manage investigator-initiated trials and liaise with CROs and third-party vendors.

Qualifications

• Advanced degree (Master’s, PhD, PharmD, or MD) with 6+ years in clinical R&D, preferably in neuropsychiatric diseases.
• Expertise in global clinical development, trial design, regulatory processes, and data analysis.
• Strong problem-solving, leadership, and communication skills.
• Experience in mid-to-late stage clinical programs and regulatory interactions.

This role offers an opportunity to contribute to innovative CNS therapies within a collaborative environment.