Director, Clinical Development Sciences

🔥 6 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 • Lead program- and compound-level development activities and multidisciplinary clinical development teams • Contribute to clinical strategy discussions and create and review clinical documents supporting regulatory submissions • Represent Clinical Development Sciences in integrated development teams to uphold scientific, ethical, and regulatory standards and support worldwide registration submissions • Lead multidisciplinary clinical development teams, including proactive risk identification and management, consistency, data quality, and scientific validity • Review medical and scientific elements of 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 for critical study documentation, including statistical analysis plans • Support optimal study execution and data collection with clinical operations, data management, and statistics • Train CRAs; select laboratory assessments for safety and pharmacodynamics; and provide input into tables, listings, and figures • Serve as SME for global marketing-application regulatory questions and support responses to CTA questions outside the US • Collaborate with study teams, data management, biostatistics, regulatory, and other functional peers • 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 sessions, and advisory boards • Provide leadership and oversight to clinical development staff and study-level scientists • Set goals and evaluate performance for direct reports; support career-path clarity, training plans, and leadership development • Perform other duties as assigned

🎯 Requirements

• 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 • 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 target audiences, including patients, regulatory agencies, FDA, EMA, investigators, and external/key opinion leader advisory panels • Advanced scientific degree (MD/PhD/PharmD) strongly preferred

🏖️ Benefits

• Equal employment opportunity commitment • Employment protections for veterans and individuals with disabilities • Federal, state, and local employment-law compliance