Global Study Associate Director, Early Phase

Overview

The Global Study Associate Director (GSAD) is a business‑critical role whose primary accountability is the delivery of clinical studies on time, within budget, and meeting quality standards set by the EPT/GPT. The GSAD leads a multidisciplinary study group, provides direction and mentorship, ensures effective partnership and collaboration among internal and external stakeholders, and oversees study governance following the Early Phase clinical outsourcing model (EPA), ICH GCP, SOPs, and company policies.

• Lead and coordinate a cross‑functional study team following the EPA outsourcing approach and its RACI framework.
• Ensure the clinical study progresses as planned and drives achievement of breakthroughs according to timelines, budget, and quality standards.
• Develop or coordinate development and maintenance of study documents, including the global study management plan, protocol, study report, and risk‑based quality and risk management plans.
• Lead and facilitate communication across all functions, provide mentorship and support to core and extended study team members.
• Serve as the main contact for the external vendor (CRO), Global/Early PT (GPT/EPT) and the clinical sub‑team (CST).
• Accountable for study performance against agreed plans, achievements, and key performance indicators (benchmarks, quality, operational).
• Maintain study tracking systems and project timelines (PLANIT, CTMS, TMF dashboard) and communicate risks and mitigation plans.
• Identify and report quality issues in accordance with SOPs.
• Proactively share findings and corrective action plans (CAPAs) with relevant partners.
• Coordinate TMF completion, ensure the TMF plan and Expected Document List (EDL) are established, and perform QC activities for TMF completeness.
• Ensure timely compliance with company‑wide governance controls (Delegation of Authority, Sunshine Act, Clinical Trial Transparency).
• Maintain inspection‑ready status per ICH‑GCP, SOPs, and relevant guidelines; act as primary Clinical Operations point of contact during audits or inspections.
• Manage risk response strategies and issue partner concern pathways for the study team.
• Serve as the primary Alexion point of contact for the CRO Project Manager, ensuring study delivery and documentation of CRO oversight.
• Oversee external service providers contracted under the EPA outsourcing model (central laboratories, IXRS, ePRO, etc.), ensuring contracted goals, timelines, and budgets are met.
• Plan, track, and forecast the Global Clinical Operations budget and timelines, coordinating study budgeting with outside providers and managing financial risks.
• Delegate and oversee team member responsibilities; conduct lessons‑learned exercises to promote continuous process improvement.
• Participate in non‑drug project work, such as process improvements and improvement projects, as agreed upon with the manager.
• Work with global and regional teams to define the accurate country footprint and obtain internal governance approvals.
• Maintain global oversight of study results, milestones, and site monitoring throughout the study lifecycle.
• Work with global and country‑level collaborators to mitigate risks or issues related to site management and monitoring.
• Support other study and functional activities as assigned.

• 5–7 years of experience conducting clinical studies, with 2 years in a leading role accountable for planning and execution of global clinical trials.
• Bachelor’s degree or equivalent experience in clinical practice/health care, life sciences, or drug development.
• Extensive knowledge of clinical research regulatory requirements and clinical study management processes.
• Strong team‑leadership abilities and proven conflict‑management skills.
• Excellent communication, interpersonal, strategic, and critical‑thinking skills.
• Strong organizational and problem‑solving skills.
• Ability to lead competing demands.

• Advanced degree (Master’s, Ph.D.) or PMP certification.
• Experience applying AI and machine learning tools, including generative AI, to streamline clinical study operations, automate workflows, analyze complex data sets, support strategic decision‑making, and enhance overall study delivery and quality.

The role is primarily office‑based, with expectations to use a computer, communicate via phone, video, and electronic messaging, collaborate with others, and maintain general availability during standard business hours. The position follows a hybrid model with a minimum of three days per week in the office.

• Annual base salary ranging from  to , with additional Variable Pay Bonus/Short‑Term Incentive opportunities and eligibility for equity‑based long‑term incentives (where applicable).
• Competitive Flex Benefits and Retirement Savings Program.
• Four weeks paid vacation and annual personal days.
• Contract or temporary positions (excluding students) are offered a Contract Benefits Program.