Director, Medical Monitoring (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 Medical Monitoring Director is a therapeutic area (TA) aligned management role reporting directly to the Head of Medical Monitoring Unit. The role will combine oversight related to the Medical Monitoring Unit scope in the relevant TA, the input to department management, and the line management accountabilities (D-E bands), if applicable. It requires extensive collaboration with experts including but not limited to medical teams accountable for medical and safety oversight of clinical trials. The individual will lead and manage teams responsible for reviewing and cleaning critical clinical data collected in clinical trials, setting up and maintaining the processes/tools, and interacting with clinical trial sites. This role may lead a cross functional team in the design and execution of a clinical study and may provide input into the global clinical development plans and strategy for a therapeutic area and must be a science-driven individual with relevant therapeutic area/indication/program experience.

You will be responsible for:

• Member of the Medical Monitoring Unit (MMU) Leadership Team, contributing to and influencing the future direction and strategy of the MMU.

• Oversee portfolio and team assigned to therapeutic areas from the MMU perspective.

• Ensure knowledge transfer, consistency, and standardization between studies within a drug program, therapeutic area, and the MMU.

• Accountable for junior MMU members performing the review and cleaning of critical clinical data for medical completeness and accuracy.

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

• Configure and employ medical review tools, including User Acceptance Testing.

• Support assigned clinical development medical monitors, physicians/scientists, the therapeutic area head, and GPT with deliverables necessary for effective clinical development plan design and execution, and therapeutic area strategy.

• Align with respective therapeutic areas to establish strategy and standards for the review of critical clinical data related to medical monitoring, performance, and quality.

• Ensure alignment with key functions involved in handling and interpreting clinical data related to medical review (e.g., Global Therapeutic Area, Data Management, Patient Safety, Centralized Monitoring, Biometrics) and recommend appropriate training.

• Support and act on behalf of the Head of MMU in leading governance and implementation, as well as developing MMU processes, initiatives, improvements, automation, and simplification (reporting implementation success measures and department metrics).

• May lead a cross-functional team in the design and execution of a clinical study and provide input into global clinical development plans and strategy for a therapeutic area.

• Provide medical perspective and advice for risk assessment and mitigation planning to make the decisions within the scope agreed.

• Collaborate as a member of COM and Global Development Operations DRS.

• Collaborate with the Head of MMU and peers to forecast resources, utilization, and functional budget.

• Maintain inspection readiness from the MMU perspective.

• Line manages MMU team members in D and E band roles, if applicable.

• Develop, build, and maintain long-term sustainable capacity, capability, and onboarding training for all MMU skills within the therapeutic area, indication, program, and/or functional area.

• Ensure employees comply with training requirements, corporate policies, procedures, and guidelines, including reporting in MyTime, financial reporting, and QI reporting.

• Work according to the agreed functional and regional SHE strategy by managing SHE risks, incidents, reporting, follow-up, and improvements.

• Responsible for the resourcing, training, goal setting, and performance management of MMU personnel.

• Maintain a positive, results-oriented work environment, build partnerships, model teamwork, and communicate openly and objectively with the MMU LT and teams.

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

• Mentor and coach employees to ensure continuous professional development.

You will need to have:

• Medical or life science degree; MD, MBBS, or equivalent for Medical Director, Medical Monitoring

• Extensive knowledge of clinical and pharmaceutical drug development process, including clinical research methodology, statistics, data analysis and interpretation, Risk-Based Monitoring principles, project and management in a global environment, required for the effective and efficient design and execution of clinical development plans and therapeutic area strategy development

• Solid level of medical knowledge in relevant therapeutic area/indication

• Extensive knowledge of applicable regulations and guidelines related to clinical development, including ICH/GCP Guidelines

• Demonstrated stakeholder management skills

• Demonstrated team leadership skills, with a proven capacity to facilitate team building and teamwork

• Demonstrates professionalism, diplomacy, mutual respect and the ability to manage/value diversity and cultural differences and promote productivity through encouragement

• Positive approach to individual, team, and business changes, perceived as opportunity to improve performance and add value to the business

• Computer proficiency

• Excellent communication and presentation skills in both spoken and written English

• Exhibit of Alexion Values and Behaviors

We would prefer for you to have:

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

• Specific therapeutic area experience

• Ability to develop advanced computer skills to increase efficiency in day-to-day tasks

• Experience in medical writing and producing patient narratives

• Experience as a line manager with a track record of developing direct reports in their professional growth

• International working experience

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.