Global Study Associate Director – Late Phase

Location: Barcelona, Spain (on-site) / 3 days working from the office and 2 days working from home

This is what you will do:

The Global Study Associate Director (GSAD) is a business-critical role whose mainaccountability isthe deliveryof clinical studies. TheGSADis responsible to lead a cross-functional study team and provide the team with direction and guidance to enable successful study delivery. The GSAD isaccountabletotheGPTforthedeliveryofastudyaccordingtoagreedupon timelines, budget, and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners.

The GSAD leads the study team in accordance with the Rare Disease Study Team Operating Model for Internal Delivery (rSOLID) and/or clinical outsourcing model (e.g., SCOPE), current clinical trial regulations (e.g. ICH GCP), current observational and post-marketing study regulations (e.g., GVP),Standard Operating Procedures (SOPs),policiesandbestpractices(e.g.job aides,guidelines),andinlinewithAlexion’s mission,values,andbehaviours.

Studies may be across various therapeutic areas and all phases (I-IV, including Late Phase, Non-Interventional, Post Authorization Safety Studies, Registries, Early Access Programs, etc.). 

You will be responsible for: 

• Leadandcoordinateacross-functionalstudyteamofexpertsinaccordancewith theinternal operating model (rSOLID) andoutsourced operating model (SCOPE)andits roles, accountabilities, and responsibilities framework (RACI) to ensure the clinical study progress as planned, driving achievement of milestones according to timelines, budget, and quality standards.

• Develop and maintain 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.).

• Leadandfacilitatecommunicationacrossallfunctionsandprovideguidanceandsupporttothe core and extended study team members as needed.

• As the leader of the Clinical Trial Team (CTT), is the main point of contactfor the Global Project Team (GPT)/Global Medical Affairsand relevant Project Subteams, egthe Clinical Sub-Team (CST). 

• Accountable for study performance against agreed upon plans, milestones, and key performance indicators (KPIs, quality and operational).

• Maintainstudy tracking systems and project timelines(e.g.,PLANIT,CTMS,TMFdashboard, etc.)andcommunicate any risks to timelines and/or quality to relevantprojects subteams, along with proposed mitigations.

• Identify and report quality issues that have occurred within the study in accordance with relevant SOPs and collaborate with all functions as necessary to overcome barriers and achievemilestones;proactivelycommunicatefindingsandcorrectiveactionplans(CAPAs)to relevant stakeholders (e.g., CPT, quality assurance staff, functional line management, etc.).

• Oversee TMF completion in accordance with relevant SOPs, including ensuringtheTMFplanandExpectedDocumentList(EDL)areinplace andthatQCactivitiesare performed on an ongoing basis to ensure TMF completeness at all times.

• Ensuretimelycompliancewithcompany-widegovernancecontrols(e.g.,Delegationof Authority, Sunshine Act, Clinical Trial Transparency, etc.).

• Ensurestudiesareinspection-readyatalltimes,accordingtoICH-GCP,GVP,SOPs,andrelevant policies/guidelines.Primary Clinical Operations point-of- contact in the event of an audit or inspection.

• Ensure that the risk response strategies and issue escalation pathways are clear to the entire study team.

• For outsourced studies, be the primary Alexion point of contact for the CRO Project Manager to ensurestudydeliveryaccordingtoagreedupontimelines,budget,and qualitystandards,while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycleofthe study, inaccordance withrelevant SOPsandguidelines(e.g., description of services, transfer of obligations, etc.).

• Ensure all external service providers (e.g., central laboratories, IXRS, ePRO, etc.) engaged at thestudy level are performing to contracted goals and timelines/budget and that adequateoversight is documented.

• Accountable for planning, tracking and forecasting the Global Clinical Operations budget and timelines for the studies against the agreed goals. Develops and 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 learnedexercises to provide continuous process improvement and sharing of best practices.

• Workonnon-drugprojectworksuchas Clinical Operationsrepresentativeinprocessimprovementsand/or leading improvement projects as discussed and agreed upon with their manager.

• Works with global and country teams to determine appropriate country footprint for the study, including consolidation of information from country teams to support internal governance approvals for the study.

• Leads and coordinates Key External Expert (KEE) outreach activities to assess study design suitability and/or identify opportunities for protocol improvement.

• Partners closely with Strategic Feasibility to develop country and site footprint proposals and patient enrolment projections for endorsement by Global Program Team (GPT)/Global Medical Affairs.

• Maintains global oversight of study deliverables, milestones, and site monitoring throughout the study lifecycle.

• Works with global and country-level stakeholders to mitigate risks or issues related to site management and monitoring as they arise.

• Support other study and functional activities, as assigned.

You will need to have:

• >7years of clinical research experience, 2of which in a leading role accountable for the planning and execution of global clinical trials.

• Bachelor’s degree or equivalent, in one of the disciplines related to clinical practice/health care, life sciences, or drug development, or commensurate work experience.

• Extensive knowledge of clinical researchregulatory requirements anddemonstrated abilities in clinical study management processes and clinical/drug development.

• Solid knowledge in observational and real-world evidence study management processes and post-marketing study regulatory requirements

• Strong, demonstrated abilities/skills in team leadership.

• Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills.

• Excellent communication and interpersonalskills.

• Strong strategic and critical thinking abilities.

• Strong organizational and problem-solvingskills.

• Ability to manage competing priorities.

• 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 an 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.

We would prefer for you to have:

• Advanced degree (Masters, Ph.D.) is desirable. 

• PMP certification desirable.