The Role

The Senior Medical Director, Clinical Development plays a key role across all stages of clinical development, from drug discovery through worldwide product registration.

The role is responsible for medical oversight of Phase I–IV site protocols in assigned clinical trials, ongoing safety oversight, and providing medical and scientific expertise to clinical and regulatory teams. The Senior Medical Director also provides clinical leadership to cross-functional project teams on development strategies, clinical study outlines, and interpretation of study results.

Key Responsibilities

Clinical Development

• Provide scientific and medical insights relevant to assigned programs and projects.
• Author, edit, and review medical and scientific elements of clinical research documents for accuracy, consistency with standards of care, logistical practicality, and internal consistency.
• Provide medical and safety input and/or author sections of regulatory documents, including IND/NDA submissions, MAAs, product labeling, and promotional materials.
• Provide medical leadership on the Product Team and Clinical/Medical/Regulatory (CMR) Subteam.
• Participate in leadership team and Board of Directors interactions when assigned.
• Present products externally to academic, regulatory, prescriber, government, and payer communities.
• Provide medical support for corporate partner interactions.
• Work with the Safety Officer to detect and communicate adverse safety signals to CMR and Product Leadership Teams.
• Contribute to scientific and medical strategy for other projects as needed.
• Identify and evaluate external epidemiologic data sources.
• Attend relevant scientific meetings and remain current with scientific literature.
• Co-author internal product presentations and briefings.
• Co-author external presentations, posters, and manuscripts with principal investigators.

Clinical Study Management

• Contribute to and advise on clinical research documents, including protocols, Informed Consent Forms, training materials, study manuals, and guidelines.
• Educate investigators and site staff on the medical and scientific aspects of protocols.
• Conduct medical monitoring, including subject eligibility review, ongoing clinical and laboratory review, and responses to medical queries from investigators and study sites.
• Support SAE management with Safety Operations, including narrative writing, analysis of similar medical events (AOSE), search terms, written analyses, and company comments as required.
• Review coding of medical history, adverse events, and concomitant medications.
• Advise Clinical Managers on clinical and laboratory monitoring schedules needed to achieve study objectives.
• Partner with Clinical and Data Managers and Clinical Scientists to ensure the quality of CRF templates and site tools.
• Conduct ongoing review of adverse events for assigned protocols and/or products.
• Oversee ethical conduct of assigned protocols.
• Monitor site compliance with eligibility criteria and study-specific procedures.
• Support Clinical Operations in detecting and communicating adverse trends in study conduct.
• Provide medical and safety input and/or author sections of Clinical Study Reports.
• Communicate with CRO staff and sites to understand adverse events and clinical and laboratory findings.
• Review site monitoring and audit reports when requested and drive corrective actions related to scientific and ethical trial conduct.
• Co-author internal study presentations and briefings.
• Co-author external study presentations, posters, and manuscripts with principal investigators.

Data Monitoring & Safety

• Lead Data Monitoring Committee (DMC) interactions regarding data and data interpretation for assigned projects.
• Manage overall DMC activities, including routine communications, when required.
• Monitor and communicate safety and operational trends throughout assigned studies.

Additional Responsibilities

• Perform other duties as assigned.

Qualifications

• MD with postgraduate training and 5+ years of clinical experience, or equivalent combination of education and experience, with direct patient care responsibilities.
• Board-eligible or board-certified in a specialty or relevant subspecialty preferred.
• Minimum 7 years of industry experience in clinical research, including medical monitoring, preferred.
• Demonstrated record of scholarship, independent research funding, publication, and/or membership in scholarly societies.
• Strong understanding of the clinical research process and its complexities.
• Experience anticipating and resolving practical issues encountered during 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 as necessary.
• Understanding of the clinical-regulatory-commercial development process.
• Ability to manage multiple projects and maintain timelines.
• Experience working effectively in cross-functional teams.
• Deep familiarity with ICH and GCP guidelines.
• Familiarity with safety reporting requirements under U.S. and European regulations.
• Experience with global regulatory authorities in major markets, including the U.S. FDA, European EMA, and Japan's MHLW.
• Excellent written and oral communication, interpersonal, and organizational skills.
• Initiative in producing high-quality work in a small-company environment.
• Roll-up-the-sleeves attitude.
• Strong project management skills.
• Ability to understand, influence, and collaborate within a diverse, team-based organization.
• Competence with standard office computer software tools.

Additional Information

This position description outlines the general nature and level of work expected for the classification and is not intended to be an exhaustive list of responsibilities, duties, or required skills. Additional responsibilities may be assigned by management as needed.

BioCryst is an equal opportunity employer committed to providing equal employment opportunities without regard to legally protected characteristics and to achieving its business objectives in compliance with applicable federal, state, and local laws.

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