Note: The job is a remote job and is open to candidates in USA. BioCryst Pharmaceuticals, Inc. develops oral small-molecule and injectable protein therapeutics for hereditary angioedema and other rare diseases. The Director, Clinical Development Sciences leads clinical development programs across study phases, overseeing protocol design, trial execution, data analysis, regulatory documentation, scientific strategy, and multidisciplinary team leadership.
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 but not limited to 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, including trial/program design, trial/program-specific data collection tools, data review tasks, and data analysis to ensure quality and consistency across the program
- 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 collection of data together with clinical operations, data management and statistics, accomplished through training CRAs, selection of laboratory assessments for safety and pharmacodynamics, and providing input into tables, listings and figures to be generated
- 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 functional area peers, including study teams, data management, biostatistics, regulatory, among others
- Support external dissemination of clinical trial data. This may include leading a product publication committee, or proposing, authoring, or reviewing abstracts, posters, and manuscripts
- Presents to and interacts with investigators and thought leaders. May conduct or be responsible for scientific training (e.g., SIVs, Investigator Meetings, or study data), clinical development and medical advisory boards
- Provides leadership and oversight to clinical development staff, including a team of study level scientists on individual studies within the assigned program
- Responsible for setting goals and staff performance evaluation for direct reports. Ensure that staff have a clear understanding for their career path. Assists with development and implementation of training plans and leadership development
- All other duties as assigned
Skills
- Bachelor's degree required
- 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
- 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
- Ability to clearly communicate information appropriate for the target audience, from individual patients to regulatory agencies, including presentations to FDA and European Medicines Agency (EMA), investigator meetings, and external/key opinion leader (KOL) advisory panels
- Advanced scientific degree (MD/PhD/PharmD) strongly preferred
- Experience in Rare Disease drug development is desirable
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