Role Summary
Associate Director Clinical Development – Immunology leading integrated clinical development plans and overseeing asset/indication clinical teams, partnering with senior leadership to drive clinical strategy and delivery.
Responsibilities
- Clinical Planning: Responsible for clinical development of the assigned compound and/or indication from asset strategy through submission, inspection, approval and post-launch support. Collaborates with asset teams to accelerate execution of the complete trial package (scope, timeline, budget and risk management). Lead the global clinical submission strategy, including scope, timeline, resource and risk management.
- Clinical Execution: Ensures collaboration with Clinical Design and cross-functional teams for effective transition to execution and delivery. Manage the global clinical submission plan, including communications to team and leadership, resource and risk management. Execute clinical plans to approved timelines and manage risks and budgets at the compound/indication level. Maintain inspection readiness and align partnerships (CROs, alliances, joint ventures).
- Effective Management: Align cross-functional resources across therapeutic areas. Ensure trial-lead competencies evolve, maintain TMF readiness, practice judgment-based decision-making, and drive continuous improvement in clinical development processes.
- People Management: Recruit, develop and retain a diverse workforce; foster inclusive culture; support talent development and ensure timely training for direct reports.
Qualifications
- Bachelor's degree, preferably in a scientific or health-related field
- 5+ years in the pharmaceutical industry and/or clinical development
- 5+ years project management experience across the clinical trial landscape
- 3+ years managing a team of direct reports virtually and across geographies/cultures
- Experience managing clinical development processes and associated tasks
- Legally authorized to work in the United States
Education
- Bachelor's degree, preferably in a scientific or health-related field
Skills
- Regulatory and process knowledge to drive decision making
- Budgeting and financial planning of clinical programs
- Cross-functional leadership and collaboration
- Risk management and critical path planning
- Vendor management (CROs, alliances, joint ventures)
- Strong communication and problem-solving abilities
Additional Requirements