Note: The job is a remote job and is open to candidates in USA. BioCryst Pharmaceuticals, Inc. is a pharmaceutical company developing therapeutics for hereditary angioedema and other rare diseases. The VP, Global Clinical Development will lead global clinical development strategy and operations across drug development stages, overseeing teams, budgets, infrastructure, regulatory compliance, vendors, and clinical program execution.
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
Skills
- MD with a minimum of 10 years pharmaceutical development experience
- At least 5 years in a senior management role
- Or an equivalent combination of education and experience
- Demonstrated drug development experience and driving results within the biotech/pharmaceutical industry. Has specific expertise in clinical trial design, conduct, analysis and interpretation of scientific data
- Skilled in building, training, mentoring, and motivating clinical development teams in industry, ideally for an emerging biopharmaceutical company pursuing novel therapeutics
- Highly developed line management and matrix team skills, including collaboration and influencing across functions at senior level
- Able to multi-task across a broad range of activities and a strong sense of priorities. Driven to progress programs and timelines at very rapid speeds and to drive extraordinary accomplishments
- Preferably gained in a sponsor and/or CRO role
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