VP, Global Clinical Development

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Deliver strategic leadership for personnel management, operational functions, integration of matrix teams, and planning of clinical development.

• Ensure effective and productive clinical development throughout all phases of drug development.

• Lead the creation and execution of initiatives that coordinate the company's clinical programs.

• Integrate the strategic clinical plan with research and product development missions.

• Oversee performance in relation to trial metrics, organizational goals, and operational strategies.

• Drive changes in Clinical Development functions to scale operations and deliver high-quality clinical trials across various assets and indications.

• Establish goals and assess performance for direct reports as well as the department.

• Support career development paths, training, and leadership advancement plans.

• Manage departmental budgets and resource allocation strategies.

• Build a quality-focused clinical infrastructure and implement necessary corrective actions.

• Develop Standard Operating Procedures (SOPs) that align with regulatory requirements and ensure their consistent implementation and documentation.

• Maintain inspection readiness for both active and completed studies.

• Formulate outsourcing strategies and oversee vendor relationships, Contract Research Organizations (CROs), and escalation management processes.

• Collaborate with stakeholders on trial design, scientific integrity, regulatory pathways, and advancement of the pipeline.

• Engage in governance bodies and processes, including the Portfolio Review Committee, stage gate reviews, and Development Review Group.

• Create communications to present the company's programs and products to potential Key Opinion Leaders (KOLs) and investigators.

• Advocate for patient-focused clinical development and represent patient advocacy and perspectives in trial planning, design, and execution.

⛳️ Requirements

• MD with a minimum of 10 years of experience in pharmaceutical development, ideally obtained in a sponsor and/or CRO setting.

• At least 5 years in a senior management position or a comparable combination of education and experience.

• Proven experience in drug development within the biotech/pharmaceutical sector.

• Proficiency in clinical trial design, execution, analysis, and interpretation of scientific data.

• Experience in building, training, mentoring, and motivating clinical development teams in the industry.

• Highly developed line management and matrix team skills, including the ability to collaborate and influence across senior-level functions.

• Capability to multitask across a wide range of activities while maintaining strong priorities.

• Motivated to advance programs and timelines at a rapid pace.

• Compliance with equal employment opportunity and applicable work authorization requirements.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career progression.

• Flexible work arrangements to support work-life balance.

• Collaborative and supportive company culture.