VP, Global Clinical Development

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COMPANY: At BioCryst , we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable protein therapeutics. Our global headquarters is in Durham, North Carolina, we have a regional office in Boston, Massachusetts, 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 or follow us on LinkedIn and Instagram . JOB SUMMARY: The VP, Global Clinical Development will provide extensive experience in personnel management, operations, matrix team integration and strategic planning in a pharmaceutical setting and will work closely with senior leadership teams and product teams in setting and meeting company goals. This position will be responsible for ensuring efficient and productive clinical development across all stages of drug development to produce high-quality clinical program results, including leading the development and implementation of new initiatives focused on the coordination of the company’s clinical programs, as well as the integration of the strategic clinical plan into the research and product development missions. The VP, Global Clinical Development will be deeply scientific in approach to drug development, patient centric, and possess a sense of urgency and creativity in planning and executing industry-leading clinical development programs. ESSENTIAL DUTIES RESPONSIBILITIES: Accountable for performance against key trial metrics, organizational objectives, and development and implementation of operational strategy across the scientific disciplines supporting Clinical Development. Leads, shapes, oversees or directs as necessary, implementation of changes required in Clinical Development functions to scale and succeed in delivering high-quality clinical trials across multiple assets and indications. Sets goals and evaluates performance for direct reports and the broader department. Ensures staff understand their career paths and supports training and leadership development plans. Responsible for departmental budgets and resourcing strategy to support needs of all clinical programs and phases. Builds a quality-focused clinical infrastructure, identifies areas for improvement, and in consultation with senior management, proposes and implements corrective actions. Accountable for development of SOPs to ensure operational processes, systems and standards are consistent with regulatory requirements and are implemented and documented consistently across trials. Ensures inspection readiness of both active and completed studies. Sets outsourcing strategy, best suited for clinical development success, in conjunction with appropriate interdepartmental team members and ensures a robust vendor oversight program. Serves as point of contact for escalation management of external vendors and/or CROs. Collaborate with stakeholders to strengthen clinical trial design, increase scientific rigor and likelihood of success, leverage appropriate regulatory pathways, and advance pipeline compounds efficiently. Fully participates in relevant governance bodies and processes including the Portfolio Review Committee, stage gate reviews and Development Review Group, providing guidance to project teams. Partners in developing a communication strategy which presents the value of the company’s programs and products to prospective KOLs and investigators. Champions a patient-focused mindset and approach that fosters collaboration and consistency across the department to “go fast because patients are waiting” with an “owner not renter” mentality. Ensures advocacy and voice of the patient is represented in the planning, design, and conduct of clinical trials. E

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