Director, Clinical Development Sciences — Global Trial Leader

BioCryst Pharmaceuticals; North Carolina; On-site; USD 180,000 - 240,000; Full time

Job summary

BioCryst Pharmaceuticals, headquartered in Durham, NC, seeks a Director of Clinical Development Sciences to lead high-quality data delivery across global development programs. You will design, oversee, and review protocols, study reports, and regulatory documents while guiding a multidisciplinary clinical development team.

You will contribute to regulatory strategy, program design, and clinical strategy discussions, ensuring robust scientific standards and timely submissions with global impact.

Qualifications

• Bachelor's degree required; advanced scientific degree strongly preferred (MD/PhD/PharmD).
• Expertise in clinical trial and program design, data interpretation, GCP, statistics, and cross-functional team management.
• Strong leadership, interpersonal, and communication skills for senior management and external stakeholders.
• Understanding of worldwide drug development, regulatory processes and regulatory submissions.

Responsibilities

• Represent Clinical Development Sciences in integrated development teams to support expeditious registration submissions.
• Lead multi-disciplinary teams to ensure data quality and scientific validity across programs.
• Review medical/scientific elements of protocols, IND/MAA/NDA modules, and clinical study reports.

Skills

Clinical trial design

Program design

Data interpretation

GCP

Statistical analysis

Cross-functional leadership

Regulatory collaboration

Communication skills

Education

Bachelor's degree

MD/PhD/PharmD (advanced degree)

Job description

BioCryst Pharmaceuticals, headquartered in Durham, NC, seeks a Director of Clinical Development Sciences to lead high-quality data delivery across global development programs. You will design, oversee, and review protocols, study reports, and regulatory documents while guiding a multidisciplinary clinical development team.

You will contribute to regulatory strategy, program design, and clinical strategy discussions, ensuring robust scientific standards and timely submissions with global impact.