Director, Clinical Development Sciences (Remote)

BioCryst Pharmaceuticals, Inc.; North Carolina; Remote; USD 180,000 - 250,000; Full time

Job summary

BioCryst Pharmaceuticals, Inc. is seeking a Director, Clinical Development Sciences to guide high-quality data across study phases for one or more product candidates.

You will lead multi-disciplinary teams, shape trial design, and contribute to regulatory submissions on a global scale. The role requires a senior scientific leader with 10+ years in pharmaceutical development, strong leadership, and excellent communication with regulators and stakeholders.

Qualifications

• Bachelor’s degree required; advanced scientific degree strongly preferred.
• 10+ years of pharmaceutical development experience with at least 3 years in a Sponsor role.
• Experience in rare disease drug development desirable.
• Demonstrated leadership, collaboration and communication with senior management and regulators.

Responsibilities

• Leads multi-disciplinary clinical development teams to ensure data quality and regulatory readiness.
• Oversees protocol design, study execution, data analysis and reporting for global programs.
• Provides SME input on regulatory questions and submissions (IND/MAA/NDA) across global markets.
• Collaborates with clinical operations, data management, biostatistics and regulatory affairs to ensure program success.
• Mentors staff and drives training, process improvements, and strategic decision-making.
• Supports external dissemination of trial data via publications and presentations.

Skills

Clinical leadership

Trial design

Regulatory strategy

Cross-functional leadership

Data interpretation

Regulatory documents

Education

Bachelor's degree

Advanced degree (MD/PhD/PharmD)

Job description

BioCryst Pharmaceuticals, Inc. is seeking a Director, Clinical Development Sciences to guide high-quality data across study phases for one or more product candidates.

You will lead multi-disciplinary teams, shape trial design, and contribute to regulatory submissions on a global scale. The role requires a senior scientific leader with 10+ years in pharmaceutical development, strong leadership, and excellent communication with regulators and stakeholders.