Associate Director (Supervisor) - Clinical Development

Role Summary

The Associate Director, Clinical Development is responsible for executing integrated clinical development plans and clinical trial packages aligned with the asset team. They lead the asset/indication clinical team, provide direction and technical expertise, and partner with senior leaders to model leadership behaviors and develop staff.

Responsibilities

• Clinical Planning: Develop the clinical plan from asset strategy through submission, inspection, approval, and post-launch support; collaborate to accelerate the complete trial package; lead global submission strategy.
• Clinical Execution: Coordinate with Clinical Design and CDTL for transition to execution; manage the global submission plan, communications, resources, and risks; oversee timelines and budget; manage risk plans and cross-functional communications; supervise partner expectations with CROs and alliances.
• Effective Management: Align cross-functional resources across therapeutic areas; ensure TMF and inspection readiness; model decision-making within compliance and quality requirements; drive continuous improvement of clinical development processes.
• People Management: Recruit, lead, develop, and retain a diverse workforce; foster inclusive culture; support talent identification and training for direct reports.

Qualifications

• Required: Bachelor's degree, preferably in a scientific or health-related field.
• Required: 5+ years' experience in the pharmaceutical industry and/or clinical development.
• Required: Legally authorized to work in the United States (visa sponsorship not anticipated).
• Preferred: Strong understanding of clinical development processes and interdependencies; demonstrated project management skills on complex/cross-functional projects; excellent communication and virtual team leadership skills; ability to coach and develop others; comfort working across geographies and cultures; PMP or similar certification; prior experience with CROs/alliances/JVs; prior submission and inspection experience; strong self-management and organizational skills; ability to influence without direct authority; travel may be required.

Education

• Bachelor's degree, preferably in a scientific or health-related field