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 uson LinkedIn and Instagram.

JOB SUMMARY:

The VP, Clinical Development plays a key role at all stages of clinical development for product programs targeting rare disease indications from the drug discovery stage through product registrations world-wide. This Physician-Leader will drive strategy for rare disease indications, while partnering closely with key internal stakeholders. Provides expert level clinical leadership in cross-functional project teams on development strategies, clinical study outlines, and data interpretation of study results. Oversees ongoing and planned product trials and the exploration of novel indications. #LI-Remote

ESSENTIAL DUTIES & RESPONSIBILITIES:

Clinical Development Responsibilities

• Creates, develops, and executes clinical program strategies for multiple rare disease indications, aligned with Product Team goals.
• Maintains up-to-date knowledge of treatment and regulatory landscape for rare 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.
• Recruits, develops, and leads a team of clinical development physicians as required for rare disease indications.
• Provides senior medical leadership on trial and program teams as assigned. May be assigned to provide representation to Product Leadership team (PLT), leadership team and BOD interactions on the project.
• Works closely with Medical Affairs in support of rare disease external stakeholder strategy.
• Accountable for medical interpretation of outcomes of clinical trials in rare disease indications.
• Act as senior rare disease 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.

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 from a US accredited institution with postgraduate training. MD/PhD preferred.
• Significant and successful drug development experience within the biotech/pharmaceutical industry, ideally has seen multiple products advance into commercialization or equivalent.
• Complement system experience highly preferred.
• Rare disease experience preferred.
• Established organizational leader who can positively influence others around them and lead by example.
• Experience with anticipating and solving the practical issues encountered in conception, development, execution, analysis, and interpretation of clinical trials.
• Strong quantitative skills, including solid familiarity with statistical and epidemiological concepts (record of publication in the field is desirable).
• Highly developed understanding of the clinical-regulatory-commercial development process and its intricacies.
• Deep familiarity with ICH and GCP guidelines.

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing 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. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.