Associate Director, Medical Review (Alexion)

This is what you will do:

The Medical Monitoring Unit is a specialized department within ARDU’s Research and Development organization dedicated to the meticulous medical review and monitoring of efficacy and safety data collected in clinical trials o ensure 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.

The Associate Director, Medical Review is 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 and maintaining the 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 with Medical Monitoring Leadership Team (LT) and the Senior Scientists group on strategy and processes for Medical Monitoring. The Associate Director, Medical Review is responsible for managing key stakeholders, representing Medical Monitoring LT in technical innovation initiatives and events, and fostering technical innovation within the Medical Monitoring team. Additionally, the Associate Director, Medical Review works closely with the MMU LT and Senior Medical Reviewers to ensure optimal utilization of systems, tools and 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, AI to leverage these technologies for portfolio delivery and to improve ways of working within and beyond Medical Monitoring.

You will be 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, clean, analyze, and review safety and efficacy data to identify trends and follow up as appropriate.

• 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.

• Provide medical 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 to benefit the 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 Review tools functionality and development.

• Ensure Data Review tools are fit for purpose, including their 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.

• Demonstrate expertise in 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 and participate in change initiatives related to the Medical Monitoring Team.

You will need to have:

Education and Experience:

• Minimum bachelor's degree in life science or a related discipline; 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 of the clinical study and drug development process.

• Knowledge of ICH/GCP Guidelines.

Technical Knowledge:

• Knowledge of clinical research methodology, 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 to facilitate team 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 and Behaviors.

We would prefer for you to have:

• Knowledge of Alexion/AZ Procedural documents, as they pertain to Study delivery systems and processes

• Experience in cross-functional pharmaceutical development

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

• Experience using electronic data capture systems, query management, and medical review tools, e.g. JReview, JMP Clinical, Elluminate, or Spotfire

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

Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.