Senior Director of Clinical Development (Pharmaceutical, Remote)

Job summary

This role is responsible for leading innovative strategies in clinical development, overseeing the implementation of solutions for complex challenges, and serving as a subject matter expert. The position involves ensuring the integrity of medical and scientific practices in clinical trials and managing relationships with internal and external stakeholders.

Qualifications

• Medical degree (e.g., MD, DO, MBBS) from a recognized institution.
• Over 7 years of experience in clinical research and development within the biopharmaceutical industry.
• Licensed to prescribe medications independently for at least 2 years post-internship.
• Experience in phase 3 clinical research.
• Proven scientific writing skills with a record of publications, posters, or presentations.
• In-depth knowledge of clinical development processes, global regulations, ICH/GCP, and adverse event management.

Responsibilities

• Lead the clinical execution of multiple high-complexity studies, ensuring alignment with business objectives.
• Develop and oversee the creation of protocol design documents and amendments, ensuring operational efficiency and quality.
• Provide medical monitoring for clinical trials, addressing inquiries from investigators and site personnel.
• Establish and manage Data Monitoring Committees and ensure compliance with risk management plans.
• Review and approve clinical documents, including Informed Consent Documents and Clinical Study Reports.
• Support regulatory filings and responses to regulatory queries as needed.

Skills

• Strong leadership and matrix management capabilities.
• Excellent communication and collaboration skills with cross-functional teams.
• Ability to analyze complex clinical data and make informed decisions.

Education

• Medical degree from an accredited institution.

Tools

• Familiarity with clinical data management systems and regulatory submission tools.