Director, Clinical Development Sciences

COMPANY:

At BioCryst, we are passionate about advancing novel therapeutics for patients with rare and serious diseases. Our structure-guided drug design process leads us to the discovery and development of novel small-molecule drugs. We integrate traditional biology and medicinal chemistry along with a wide array of advanced technologies to understand the three-dimensional structures of active sites of target enzymes. Our scientists then design molecular structures to create bespoke drugs for patients. We focus on therapeutic areas with either no available treatments or large unmet patient needs. BioCryst’s US headquarters are located in Durham, North Carolina, our European headquarters in Dublin, Ireland and our Discovery Center of Excellence in Birmingham, Alabama. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit the Company’s website at www.biocryst.com.

JOB SUMMARY:

The Director, Clinical Development Sciences draws on their clinical and scientific knowledge to lead the delivery of high-quality data from multiple sources while supporting the management of global development programs for one or more product candidates, in all study phases. The Director plays a key role in development program design, conduct and oversight, including protocol design, execution, analysis and reporting. The Director will take a leadership role in program and compound level development and a leadership role on the multi-disciplinary clinical development team. He/she will be an active contributor in clinical strategy discussions and in the creation and review of clinical documents to support regulatory submissions. The Director will contribute to program design and oversight of ongoing study conduct and data analysis activities, identify trends and areas for training or process improvements, in support of high-quality data program wide. #LI-Remote

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Write, edit, and review medical and scientific elements of clinical research and regulatory documents, including but not limited to protocols, IBs IND, MAA or NDA modules, and clinical study reports.
• Provides input and oversight to critical study level documentation for key studies, including the statistical analysis plan.
• Responsible for setting goals and staff performance evaluation for direct reports, and for departments as a whole. Ensures that staff have a clear understanding for their career path. Assists with development and implementation of training plans and leadership development.
• Support external dissemination of clinical trial data. This may include leading a product publication committee, or proposing, authoring, or reviewing abstracts, posters, and manuscripts.
• Serves as subject matter expert for assigned clinical develop program(s) and works closely with relevant stakeholders to lead development and implementation of trial/program-specific data collection tools, data review tasks, and data analysis to ensure quality and consistency across the program.
• Leads multi-disciplinary clinical development teams to ensure proactive risk identification and management, consistency across development programs, data quality and scientific validity.
• Contributes toward overall process decisions related to data collection and handling, data processes.
• Provides training and support to Investigator Meetings and other events, and to internal study teams as needed.
• Establish and maintain effective communication and collaboration with functional area peers, including study teams, data management, biostatistics, regulatory, among others.
• Establish and maintain quality corporate relationships with leading investigators and clinical signs on assigned protocols in collaboration with Clinical Operations team
• Provides leadership and oversight to clinical development staff on individual studies within the assigned program.
• All other duties as assigned.

 

EXPERIENCE & QUALIFICATIONS:

• Masters or PhD degree in biological sciences, pharmacy nursing or related field strongly preferred.
• A minimum of 10 years of pharmaceutical development experience including experience in a Sponsor CRO role and broad experience in both clinical study management and data management or an equivalent combination of education and experience.
• Skilled with clinical trial design and conduct, GCP, statistical analysis, management of cross-functional clinical/ regulatory teams and CROs.
• Understanding of pharmaceutical business, worldwide drug development and regulatory process.
• Expertise in clinical trial design, conduct and interpretation of scientific data.
• Ability to work independently and ac