VP, Global Clinical Development

EXPERIENCE & QUALIFICATIONS

• MD with a minimum of 10 years pharmaceutical development experience, preferably gained in a sponsor and/or CRO role and 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.

• 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.