Associate Director, Medical Review (Alexion)

This is what you will do:

The Medical Monitoring Unit is a specialized department within ARDUs Research and Development organization dedicated to the meticulous medical review and monitoring of efficacy and safety data collected in clinical trialsoensure completeness robustness consistency and accuracy of critical medical data to uphold the highest standards of data integrity and maintain the safety of clinical trial participants. The mission of the Medical Monitoring Unit is ensuring that the clinical data collected within the study will allow determination of the benefits and risks of the compound as well as to allow for the intended label indication by involvement in activities related to the design conduct monitoring data interpretation and reporting of individual clinical trials.

TheAssociate Director Medical Reviewis an expert in technology/tools/data supporting and overseeing Senior Medical Reviewers responsible for reviewing and cleaning critical medical data collected in clinical trials and/or setting up andmaintainingthe processes/tools. This individual share accountability for the Medical Monitoring service ensuring high-quality medical data review related to efficacy and safety at study level. The role involves active collaboration withMedicalMonitoring Leadership Team (LT) and the Senior Scientists group on strategy and processes forMedicalMonitoring. The Associate Director MedicalReviewis responsible formanaging key stakeholdersrepresentingMedicalMonitoring LT in technical innovation initiatives and events and fostering technical innovation within the Medical Monitoring team. Additionally the Associate Director Medical Review worksclosely withthe MMU LTand Senior Medical Reviewers to ensureoptimalutilizationof systemstoolsand processes supported by programming teams in alignment with predefined plans and business needs to deliver the portfolio. They stay abreast of trends in tools automation AItoleveragethese technologies forportfolio delivery and to improve ways of working within and beyondMedicalMonitoring.

You willbe responsible for:

• Provide strategic assessment with an enterprise mindset and accountability for the proactive development and execution of a Medical Monitoring strategy at the study level.

• Lead the implementation of best practices optimization and standardization of work processes and tools.

• Explore technologies to propose and lead automation and improvement of Medical Monitoring processes tools and systems.

• Lead the execution of clinical trials; monitor cleananalyze and review safety and efficacy data toidentifytrends and follow up asappropriate.

• Support the execution of clinical trials and associated data collection activities providing guidance to the clinical study team on-site training oversight patient recruitment country and site feasibility assessments and selection ongoing data monitoring and study closeout.

• Support teams in preparing clinical study-related documents including protocols charters statistical summary reports meeting presentations publications and clinical sections of regulatory documents (may support several studies in parallel).

• Participate in investigator meeting planning and execution including on-site initiation meetings.

• Providemedical advice for risk assessment and mitigation planning at the study level.

• Build networks stakeholder relationships and collaborate with technology functions across the organization (e.g. DS&AI Robotics teams driving initiatives) and externally tobenefitthe Medical Monitoring Team.

• Lead and support functional and cross-functional improvements.

• Oversee improvements on study project and process levels assigned to subordinates.

• Act as an expert on data analysis visualization and Data Reviewtoolsfunctionality and development.

• Ensure Data Review tools are fit forpurpose includingtheir configuration User Acceptance Testing and employment.

• Maintain a positive results-oriented work environment build partnerships with other functions and communicate openly balanced and objectively.

• Foster a culture of courageous leadership creativity speak-up culture and feedback sharing.

• Mentor and coach individuals to ensure continuous professional development and development planning.

• Demonstrateexpertisein technology tools systems and processes used to support the Medical Monitoring scope.

• Ensure the quality of work delivered by staff reporting to them.

• Cooperate with the Medical Monitoring Leadership Team and other roles across Alexion for the advancement and maintenance of tools processes standards and frameworks.

• Demonstrate willingness to take on any level of project activity consistent with experience in support of the Medical Monitoring Team.

• Manage projects andparticipatein change initiatives related to the Medical Monitoring Team.

You will need to have:

Education and Experience:

• Minimumbachelorsdegree in life science ora relateddiscipline; MD MBBS or equivalent for Associate Medical Director Medical Monitor Scientist.

• Minimum three years of experience working on clinical studies in the Biotech/Pharma/CRO industry or equivalent.

• Understanding ofthe clinical study and drug development process.

• Knowledge of ICH/GCP Guidelines.

Technical Knowledge:

• Knowledge of clinical researchmethodology statistics data analysis and interpretation and familiarity with Risk-Based Monitoring principles in clinical trials.

• Knowledge of SAE reporting requirements.

• Knowledge of medical coding dictionaries and conventions (e.g. MedDRA WHO DD).

Skills and Abilities:

• Excellent analytical skills.

• Proven ability to prioritize and manage multiple tasks with conflicting deadlines.

• Proven ability to interact effectively with all levels of management.

• Demonstrated leadership ability in a team environment; ability tofacilitateteam building and teamwork.

• Excellent organization and time management skills with the ability to multi-task in a high-volume environment with shifting priorities.

• Proven negotiation collaboration interpersonal problem-solving and conflict resolution skills.

• Change management skills.

• Supervising others work and providing support in areas of expertise.

• Negotiation influencing and leadership skills for stakeholders.

• Excellent communication and presentation skills.

• Advanced computer skills (Microsoft Outlook Excel and Microsoft Power Platform).

• Excellent knowledge of spoken and written English.

• Exhibit Alexion Values andBehaviors.

We wouldpreferfor you to have:

• Knowledge of Alexion/AZ Procedural documents as they pertain to Study delivery systems andprocesses

• Experience in cross-functional pharmaceuticaldevelopment

• Experience in review of patient-level clinical data including clinicaldata

• Experience using electronic data capture systems query management and medical review toolse.g.JReview JMP ClinicalElluminate or Spotfire

• Programming experience in data analysis and/or data mining set-up (e.g.Python R SAS)