Global Study Associate Director, Early Phase

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Overview:

The Global Study Associate Director (GSAD) is a business-critical role whose main accountability is delivery of clinical studies. Responsibility for leading a multidisciplinary study group and providing the group with direction and mentorship to enable successful study delivery falls to the GSAD. The GSAD is accountable for delivering a study on time, within budget, and meeting quality standards set by the EPT/GPT. They ensure effective partnership and collaboration among the research group and with external partners.

The GSAD leads the study team following the Early Phase clinical outsourcing model (EPA), current clinical trial regulations (e.g. ICH GCP), Standard Operating Procedures (SOPs), policies and standard methodologies (e.g. job aides, guidelines), and in line with Alexion’s mission, values, and behaviours.

Studies are focused on Early Phase Healthy Volunteers and may be placed across various therapeutic areas.

Responsibilities:

• Lead and coordinate a cross-functional study team of experts applying the EPA outsourcing approach and its (RACI) framework. Ensure the clinical study progresses as planned. Drive achievement of breakthroughs according to timelines, budget, and quality standards.
• Develop or coordinate development/maintenance of relevant study documents/plans (e.g., global study management plan and its relevant components, etc.) including required input into clinical study protocol, clinical study report, and study level quality and risk management planning (e.g., risk based quality management, proactive risk and contingency plans, inspection readiness plans, etc.).

• Lead and facilitate communication across all functions and provide mentorship and support to the core and extended study team members as needed.
• Leading the Clinical Trial Team (CTT), the GSAD serves as the main contact for the external vendor (CRO). The GSAD also contacts Global/Early PT (GPT/EPT) and the clinical sub-team (CST).
• Accountable for study performance against agreed upon plans, achievements, and key performance indicators (benchmarks, quality and operational).
  • Maintain study tracking systems and project timelines (e.g., PLANIT, CTMS, TMF dashboard, etc.) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations.
  • Identify and report quality issues that arise during the study following applicable SOPs. Work with all functions as needed to overcome barriers and reach achievements. Proactively share findings and corrective action plans (CAPAs) with relevant partners (e.g., CPT, quality assurance staff, functional line management, etc.).
  • Coordinate TMF completion according to relevant SOPs. Confirm the TMF plan and Expected Document List (EDL) are established. Perform QC activities regularly to keep the TMF completeness.
  • Ensure timely compliance with company-wide governance controls (e.g., Delegation of Authority, Sunshine Act, Clinical Trial Transparency, etc.).
  • Ensure studies are inspection-ready at all times, according to ICH-GCP, SOPs, and relevant policies/guidelines. Primary Clinical Operations point of-contact in the event of an audit or inspection.
  • Ensure that the risk response strategies and issue partner concern pathways are clear to the entire study team.
• For outsourced studies, be the primary Alexion point of contact for the CRO Project Manager to ensure study delivery according to agreed upon timelines, budget, and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant SOPs and guidelines (e.g., description of services, transfer of obligations, etc.).
• Ensure all external service providers contracted under the EPA outsourcing model (E.g. central laboratories, IXRS, ePRO etc.) meet contracted goals, timelines, and budgets at the study level. Provide detailed oversight of their performance.
• Accountable for planning, tracking and forecasting the Global Clinical Operations budget and timelines for the studies against the agreed goals. Coordinates development of study(s) budget by the outside provider. Maintains budgets for study(s) that include short and long-range clinical forecasting and monthly accruals based on clinical activity to support Clinical Development financial goals, and identifying any financial risks and mitigation plans (as a part of the ongoing study change control process).
• Delegate and oversee team member responsibilities.
• Conducts lessons learned exercises to provide continuous process improvement and sharing of best practices.
• Work on non-drug project work such as Clinical Operations representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.
• Works alongside global and regional teams to define the accurate country footprint pertaining to the study. This entails gathering information from country teams to help in acquiring internal governance approvals for the study.
• Maintains global oversight of study results, milestones, and site monitoring throughout the study lifecycle.
• Works with global and country-level collaborators to mitigate risks or issues related to site management and monitoring as they arise.
• Support other study and functional activities, as assigned.

Qualifications:

• 5 -7 years of experience conducting clinical studies, 2 of which in a leading role accountable for the planning and execution of global clinical trials.
• Bachelor’s degree or equivalent experience in one of the fields related to clinical practice/health care, life sciences, or drug development, or commensurate work experience.
• Extensive knowledge of clinical research regulatory requirements and proven abilities in clinical study management processes and clinical/drug development.
• Strong, proven abilities/skills in team leadership.
• Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and collaborators, along with strong conflict management skills.
• Excellent communication and interpersonal skills.
• Strong strategic and critical thinking abilities.
• Strong organizational and problem-solving skills.
• Ability to lead competing demands.
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without accommodation, to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Preferred Qualifications:

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

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.

Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.

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AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs.  In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role).  Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.