Director, Clinical Development Sciences — Global Trials Lead

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

Job summary

BioCryst Pharmaceuticals, Inc. in Durham, NC, seeks a Director, Clinical Development Sciences to lead data delivery across study phases and support global development programs for one or more product candidates.

You will design protocols, oversee analysis, contribute to regulatory submissions, mentor a science team, and drive high-quality data, with collaboration across clinical operations, regulatory, biostatistics, and data management.

Qualifications

• Bachelor’s degree required; advanced degree strongly preferred.
• Minimum of 10 years pharmaceutical development experience; 3+ years in a Sponsor role.
• Expertise in clinical trial and program design, data interpretation, GCP, statistics, and cross-functional teams.
• Experience in Rare Disease drug development is desirable.
• Proven track record in protocol development, execution, and reporting in industry.
• Understanding of pharmaceutical business, global regulatory processes.
• Ability to lead independently and manage multiple studies concurrently.
• Strong leadership and interpersonal skills; effective communication with senior management and regulators.

Responsibilities

• Represents Clinical Development Sciences in integrated development teams to ensure high scientific, ethical and regulatory standards and expeditious registration submissions worldwide.
• Leads multi-disciplinary clinical development teams to ensure proactive risk identification and data quality and scientific validity.
• Responsible for content and/or scientific review of medical and regulatory documents (protocols, INDs, MAA/NDA modules, PSR documents, study reports).
• Serves as SME for assigned clinical development programs; leads trial design and data collection tools and data review tasks.
• Provides input into the statistical analysis plan and study-level documentation.
• Oversees training of CRAs and contributes to generating tables, listings and figures.
• Serves as SME for regulatory questions on marketing applications globally; supports CTAs outside the US.
• Maintains effective communication with study teams, data management, biostatistics, and regulatory peers.
• Supports external dissemination of clinical trial data; may lead publication efforts.
• Presents to investigators; may conduct scientific training and advisory boards.
• Provides leadership and performance evaluation for staff; assists with training plans.

Skills

Leadership

Clinical development

GCP

Statistics

Cross-functional

Regulatory communication

Rare disease

Independence

Education

Bachelor’s degree

Advanced scientific degree (MD/PhD/PharmD)

Job description

BioCryst Pharmaceuticals, Inc. in Durham, NC, seeks a Director, Clinical Development Sciences to lead data delivery across study phases and support global development programs for one or more product candidates.

You will design protocols, oversee analysis, contribute to regulatory submissions, mentor a science team, and drive high-quality data, with collaboration across clinical operations, regulatory, biostatistics, and data management.