Senior Medical Director, Clinical Development

🔥 20 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏱ Part Time

🟠 Senior

👨‍⚕️ 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

• Provide scientific and medical insights for assigned programs and projects • Write, edit, and review medical and scientific elements of clinical research and regulatory documents • Provide medical and safety input to IND/NDA submissions, MAAs, product labeling, promotional materials, and Clinical Study Reports • Lead medical activities on Product Teams and Clinical/Medical/Regulatory Subteams • Present products to academic, regulatory, prescriber, government, and payer communities • Support corporate partner interactions • Detect and communicate adverse safety signals and trends • Identify and evaluate external epidemiologic data sources • Attend scientific meetings and maintain current scientific expertise • Co-author internal and external presentations, posters, and manuscripts • Advise on protocols, informed consent forms, training materials, study manuals, and guidelines • Educate investigators and site staff on protocol medical and scientific aspects • Conduct medical monitoring, including subject inclusion review, clinical and laboratory findings review, and responses to investigator queries • Manage serious adverse events with Safety Operations, including narratives and analyses when requested • Review coding of medical history, adverse events, and concomitant medications • Advise on clinical and laboratory monitoring schedules and contribute to CRF templates and site tools • Review adverse events and oversee ethical conduct, eligibility compliance, and study-specific procedures • Support clinical operations in detecting and communicating adverse study trends • Review site monitoring and audit reports and drive corrective actions when requested • Communicate with CRO staff and sites regarding adverse events and clinical and laboratory findings • Lead Data Monitoring Committee interactions and manage routine DMC communications when required • Perform other duties as assigned

🎯 Requirements

• MD with postgraduate training and 5+ years of clinical experience (or an equivalent combination of education and experience) with direct patient care responsibilities • Board-eligible or board-certified in a specialty or relevant subspecialty preferred • Demonstrated industry experience in clinical research, including medical monitoring; minimum 7 years preferred • Demonstrated track record of scholarship, independent research funding, publication, and/or membership in scholarly societies • Understanding of the clinical research process and its intricacies • Experience anticipating and solving practical issues encountered in clinical trial execution • Strong leadership and process improvement skills • Excellent interpersonal communication, organization, and presentation skills • Strong quantitative skills, including familiarity with statistical and epidemiological concepts • Ability to maintain professional skills and learn new ones when necessary • Understanding of the clinical-regulatory-commercial development process and its intricacies • Ability to manage multiple projects and maintain timelines • Ability to work in cross-functional teams • Deep familiarity with ICH and GCP guidelines • Familiarity with safety reporting requirements under US and European regulations • Experience with global regulatory authorities in one or more major markets, including USA (FDA), Europe (EMA), and Japan (MHLW) • Initiative in producing high-quality work product in a small company environment • Strong project management skills • Ability to understand, influence, and collaborate in a diverse team-based organization • Competence with standard office computer software tools

🏖️ Benefits

• Equal employment opportunity commitment • Compliance with federal, state, and local law