VP, Clinical Development

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we’ve been guided by our passion for not settling for “ordinary” in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama. Our global headquarters is in Durham, North Carolina, our European headquarters is in Dublin, Ireland and our employees span the globe across sites in multiple countries. 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 our website at www.biocryst.com or follow us on LinkedIn and Instagram.

ESSENTIAL DUTIES & RESPONSIBILITIES:

Clinical Development Responsibilities

• Creates, develops, and executes clinical program strategies for ophthalmology disease indications, aligned with Product Team goals.
• Maintains up-to-date knowledge of treatment and regulatory landscape for ophthalmology disease indications relevant to the company’s programs. Contributes to design of registration strategy for rare disease indications, including assessment of precedent clinical endpoints and relevance for company program goals.
• Provides strategic medical guidance and matrixed-leadership to cross functional clinical team members, including clinical scientists, development physicians, non-clinical and others to identify and execute optimal development plans.
• Provides senior medical leadership on trial and program teams and representation of medical strategy as requested at leadership team and BOD interactions on the project.
• Collaborates with Medical Affairs and Clinical Science to develop and execute ophthalmology KOL strategy, providing scientific and medical expertise in support of ongoing KOL engagement and advisory boards.
• Accountable for medical interpretation of outcomes of clinical trials in ophthalmology indications.
• Act as senior ophthalmology medical leader in presenting the product externally to academic, regulatory, prescriber, government, and payer communities.
• Responsible for oversight of and if needed, editing and review of medical and scientific elements of regulated clinical research documents to ensure strategic alignment, accuracy, consistency with standard of care, logistical ease, and internal consistency, as assigned.
• Supervises or provides medical input to, reviews, or if needed authors, relevant sections of regulatory documents such as IND/NDA submissions, MAAs, Product Labeling and promotional materials.
• Provides medical support in corporate partner interactions on assigned projects.
• Accountable, together with Safety Officer, for detecting and communicating adverse safety signals to relevant internal stakeholders.
• Identifies and evaluates external epidemiologic data sources as required.
• Attends appropriate scientific meetings and stays up to date with relevant scientific literature to maintain expertise.
• Co-authors external presentations, posters, and manuscripts in collaboration with principal investigators on product, aligned with established authorship standards and policies.

Clinical Study Responsibilities

• Oversees and if needed contributes to and advises on the development of clinical research documents including protocols, Informed Consent Forms, Training materials, Study Manuals, Guidelines, etc.
• Educate investigator and site staff on the medical and scientific aspects of protocols, as assigned.
• Supports clinical operations in detection and communication of adverse trends in any aspect of study conduct, as appropriate to the issue and audience.
• Supervises medical input into, reviews, and if necessary, may author sections of Clinical Study Reports.

 

EXPERIENCE & QUALIFICATIONS:

• MD/DO with postgraduate training, active medical license and at least 5-years’ clinical experience with direct patient care responsibilities.
• Demonstrated drug development experience within the biotech/pharmaceutical industry.
• Experience with anticipating and solving the practical issues encountered in conce