Senior Director of Clinical Development (Pharmaceutical, Remote)

Job summary

This role is responsible for leading innovative strategies in clinical development, ensuring the integrity of medical practices, and overseeing the execution of complex clinical studies with significant business impact. The position serves as a primary contact for both internal and external stakeholders regarding clinical and medical protocol aspects.

Qualifications

• Medical degree (e.g., MD, DO, MBBS) from an accredited institution.
• 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.
• Proven experience in phase 3 clinical research.
• Strong scientific writing skills demonstrated through publications and presentations.
• In-depth knowledge of clinical development regulations and adverse event management.

Responsibilities

• Lead the clinical execution of high-complexity studies, ensuring operational efficiency and participant engagement.
• Develop and oversee protocol design documents and amendments, ensuring compliance and quality.
• Provide medical monitoring and oversight for clinical trials, addressing safety findings and adverse events.
• Manage and approve informed consent documents and responses to stakeholder inquiries.
• Conduct periodic safety data reviews and ensure compliance with trial management frameworks.
• Contribute to regulatory filings and support audit responses 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

• Primary medical degree required, with ongoing registration in good standing.

Tools

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