Remote Director, Clinical Development Sciences

BioCryst Pharmaceuticals, Inc.; Northern (KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

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

You will guide protocol design, execution, analysis, and reporting while contributing to regulatory submissions and global development strategy. The role requires a Doctoral-level scientific background with a track record in pharmaceutical development, protocol execution, and leadership of cross-functional teams.

Qualifications

• Bachelor’s degree required.
• Advanced scientific degree (MD/PhD/PharmD) strongly preferred.
• A minimum of 10 years of pharmaceutical development experience, including at least 3 years in a Sponsor role and broad experience in clinical development or an equivalent combination of education and experience.
• Expertise in clinical trial and program design, conduct, interpretation of scientific data, GCP, statistical analysis, and management of cross-functional clinical/regulatory teams.
• Experience in Rare Disease drug development is desirable.
• Demonstrated track record of scholarship, publication and membership in scholarly societies OR proven track record of successful protocol development, execution, and reporting in industry.
• Understanding of pharmaceutical business, worldwide drug development and regulatory process.
• Ability to work independently and accountable for managing multiple studies concurrently.
• Strong leadership and inter-personal skills, the ability to manage and cultivate relationships, the ability to recommend/make high-level decisions and to communicate effectively on a senior management level and externally.
• The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities so classified.

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 management, consistency across development programs, data quality and scientific validity.
• Responsible for the content and/or scientific review of medical and scientific elements of clinical research and regulatory documents, including protocols, IBs, IND, MAA or NDA modules, PIP/PPSR documents, and clinical study reports.
• Serves as subject matter expert for assigned clinical development program(s) and works closely with relevant stakeholders to lead development and implementation of trials and programs.
• Provides input and oversight into critical study level documentation for key studies, including the statistical analysis plan.
• Is a primary member of the clinical development study team responsible for optimal study execution and data collection with clinical operations, data management and statistics.
• Serves as SME for regulatory questions on marketing applications globally and supports study level scientists in responding to regulatory questions on CTAs outside the US.
• Establish and maintain effective communication and collaboration with peers in study teams, data management, biostatistics, regulatory, among others.
• Support external dissemination of clinical trial data through publications, abstracts, posters and manuscripts.
• Presents to and interacts with investigators and thought leaders; may conduct scientific training.

Skills

Scientific leadership

Clinical development

Regulatory strategy

GCP compliance

Cross-functional collaboration

Program management

Education

Bachelor's degree

MD/PhD/PharmD

Job description

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

You will guide protocol design, execution, analysis, and reporting while contributing to regulatory submissions and global development strategy. The role requires a Doctoral-level scientific background with a track record in pharmaceutical development, protocol execution, and leadership of cross-functional teams.