Assoc. Director, Clinical Development Sciences
Anywhere, United States
Posted on: June 20, 2022
Closing: July 20, 2022
Position Type: Full Time
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.
The Assoc. Director, Clinical Development Sciences draws on their extensive clinical and scientific knowledge to lead the delivery of high-quality data from multiple sources while supporting the management of global clinical studies for one or more product candidates, in all study phases. The Assoc. Director plays a key role in all aspects of study conduct including protocol design, study start-up, execution, analysis and reporting. The Assoc. Director will also perform an in-depth review of clinical study protocols to identify the critical data points needing to be collected for a study to meet its endpoints. He/she works closely with the Clinical Study Manager and Data Management to develop Case Report Forms (CRFs), eDiaries, and other systems targeted to evaluate study endpoints, as well as providing input on the development of edit checks that are critical to ensuring data quality and prompt notification of potential safety or eligibility concerns, in compliance with regulatory and ICH/FDA GCP guidelines. The Assoc. Director will perform ongoing data analysis as requested and identify trends and areas for training or process improvements, in support of high-quality data program-wide. He/she will participate in cross-functional data quality review meetings and dry run review meetings run by Biostatistics. #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, statistical analysis plans, regulatory documents, key study plans, and clinical study reports.
• Participates in vendor selection and management, especially pertaining to data-related vendors such as the eCRF and/or eDiary vendor(s), study budget tracking, and other tasks as needed. He/she will provide training and support to CRAs, sites, and internal study teams with regards to best practice and issue resolution for study data from multiple sources. The Associate Director will also support study management-related tasks as required, such as regulatory submissions, co-monitoring, monitoring subject compliance with patient-entered clinical outcome assessments, generate/review study plans and documents, or other tasks as needed.
• Serves as subject matter expert and works closely with relevant stakeholders to lead development and implementation of trial/program-specific data collection tools, including but not limited to layout of data collection tool(s), edit checks, and associated study documentation such as Data Management Plan, Data Validation Specifications, Completion Guidelines or other vendor-specific documentation.
• Leads and delegates clinical data review tasks and data analysis to ensure data quality and consistency across program, including the identification of data and query trends to contribute to overall data quality.
• Participates in protocol review to ensure the data collection requirements are clear and supportive of the study endpoints.
• Contributes toward overall process decisions related to data collection and handling, data processes.
• Provides input on critical study documentation including but not limited to the statistical analysis plan and clinical study report.
• Contributes to management of eCRF and eDiary vendors (or others as requested) and budgets to ensure timely and cost-effective implementation of Clinical Development Plan, as assigned.
• Provides training and support to sites and CRAs at 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
• Participate in development of publication strategies, writing and editing of draft presentations and manuscripts
• All other duties as assigned.
EXPERIENCE & QUALIFICATIONS:
• Bachelor’s degree in biological sciences, pharmacy nursing or related field preferred.
• A minimum of 10 years of pharmaceutical development experience in a Sponsor and/or 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 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.
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, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.
BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.
Posted on: June 20, 2022
Closing: July 20, 2022
Position Type: Full Time