Director, Clinical Development Sciences

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🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

👻 Ghost score 10%

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BioCryst Pharmaceuticals, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $450M Post-IPO Debt - BioCryst Pharmaceuticals on 2023-04

Healthcare • Consulting • Logistics

BioCryst Pharmaceuticals, Inc. is a global biotechnology company focused on the discovery, development, and commercialization of novel oral small-molecule and protein therapeutics for rare diseases, notably hereditary angioedema (HAE). Founded in 1986, BioCryst uses structure-guided drug design, medicinal chemistry, and advanced technologies to develop first-in-class or best-in-class medicines, and works closely with patients, advocacy groups, and global partners to bring treatments to market.

📋 Description

• Lead delivery of high-quality data from multiple sources while supporting global development programs for one or more product candidates across all study phases • Lead development program design, conduct, oversight, protocol design, execution, analysis, and reporting • Represent Clinical Development Sciences in integrated development teams to ensure high scientific, ethical, and regulatory standards and expeditious worldwide registration submissions • Lead multidisciplinary clinical development teams, including proactive risk identification and management, consistency across programs, data quality, and scientific validity • Own or scientifically review medical and scientific elements of clinical research and regulatory documents, including protocols, IBs, IND, MAA/NDA modules, PIP/PPSR documents, and clinical study reports • Serve as subject matter expert for assigned clinical development programs and lead trial/program design, data collection tools, data review, and data analysis • Provide input and oversight into critical study-level documentation, including statistical analysis plans • Support optimal study execution and data collection with clinical operations, data management, and statistics, including CRA training, laboratory assessment selection, and input into tables, listings, and figures • Serve as SME for global marketing application regulatory questions and support responses to CTA questions outside the US • Establish communication and collaboration with functional peers, study teams, data management, biostatistics, and regulatory teams • Support external dissemination of clinical trial data through publication committees, abstracts, posters, and manuscripts • Present to and interact with investigators and thought leaders; conduct or oversee scientific training, investigator meetings, study-data training, clinical development, and medical advisory boards • Provide leadership and oversight to clinical development staff and study-level scientists • Set goals and conduct performance evaluations for direct reports; support career pathing, training plans, and leadership development • Perform other duties as assigned

🎯 Requirements

• Bachelor’s degree required • Advanced scientific degree (MD/PhD/PharmD) strongly preferred • 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 manage multiple studies concurrently • Strong leadership and interpersonal skills; ability to manage and cultivate relationships, make high-level decisions, and communicate effectively at senior management level and externally • Ability to communicate information appropriately for audiences ranging 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

🏖️ Benefits

• 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 • Compliance with federal, state and local law • Protected veteran and disability employment protections