Associate Director Senior Study Lead

The Associate Director Senior Study Lead is the leader of the cross-functional clinical trial team (CTT), who guides planning and management of the assigned clinical study/studies end-to-end to achieve objectives.

Accountable for proactive, iterative operational planning with effective contingencies and embedded risk management mindset in CTT. Oversees budget and people allocation within assigned study/studies. Contributes in promoting operational excellence through process improvement and knowledge sharing across studies. Fosters an empowered, psychologically safe organization that can navigate a matrix environment, learns, and adjusts quickly to changing conditions and business needs.

Key accountabilities

• Executes and delivers clinical studies; guides planning and decision making at study-level
• Acts as the CTT product owner with clear and focused duties and responsibilities per the agile ways of working
• Active member of a Clinical Operations community within the study leadership organization
• Promotes operational excellence in the shared development of global clinical study protocol(s), clinical study report(s), and other study-related documents

Deliverables

• Patient recruitment, clinical data, study documentation and study reports
• Efficient delivery of the protocol, ICF, Monitoring Plan, and CSR in quality and on time
• Cost effective management of study budget
• Proactive, iterative operational planning with effective contingencies and embedded risk management mindset in CTT

Key expertise and skillset

• Bachelor's degree in life sciences/healthcare (or clinically relevant degree) is required. Advanced degree is strongly preferred.
• ≥ 4 years of recent involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV of standard to high complexity and priority.
• ≥ 3 years of recent contribution to and accomplishment in all aspects of conducting clinical studies of standard to high complexity and priority (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry or a contract research organization, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities
• Experience in managing people globally in a complex matrix environment preferred
• Management of virtual teams. Proven ability and strong experience leading teams and building capabilities
• Excellent communicator and presenter (oral and written); ability to communicate at all levels
• Excellent organization and prioritization
• Strong negotiation and conflict resolution skills and enterprise mindset, demonstrated by ability to drive for aligned solutions
• Fluent English, oral and written