Associate Director, Clinical Trial Transparency Anonymizations (Alexion)

This position is accountable for working autonomously and globally with systems and process owners, business areas, the Data Privacy Office, and vendors to design, implement, and refine industry-leading methodology for automated clinical data and document anonymization and data privacy protection. This individual collaborates cross functionally, monitors regulations and industry trends, and applies appropriate analysis tools to generate best-in-class anonymized documents for public disclosure and external data sharing. This position will function with limited supervision as required, with dotted line reporting to AZ CTT leadership.  

Principal Responsibilities

To support Alexion’s mission to improve the lives of people affected by rare diseases, the Medical Writing & Clinical Trial Transparency (MW&CTT) team drives the development of strategic and regulatory-compliant documents to enable clinical research and regulatory approval of new therapies, and ensures Alexion’s continued compliance with laws, policies, regulations, and public commitments for transparency and disclosure.

CTT is responsible for posting clinical trial information to public websites and preparing clinical documents and data so they can be shared publicly to meet regulatory requirements and company commitments.

The Associate Director, Alexion CTT Anonymizations, is expected to:

• Perform the CTT Lead role for assigned clinical document anonymization packages, ensuring full work delivery, and author anonymization reports for assigned packages.

• Manage and refine data and document anonymization methodologies, including analysis of system capabilities to continuously improve anonymization rules.

• Ensure a structured approach with appropriate level of quality versus risks of anonymization methods.

• Monitor industry best practices and anonymization tool landscape to meet business needs and regulatory requirements, in collaboration with end users and customers.

• Report observations and risks related to tools and methods analysis.

• Manage methods adjustments and drive communication with Data Privacy Office as well as vendors to track new system capabilities.

• Provide data for periodic and ad hoc quality and compliance reports, presentations, and dashboards for Alexion and AZ CTT leadership.

• Coach and mentor CTT colleagues and drive delivery of anonymized clinical documents.

• Balance multiple priorities and stakeholders simultaneously to meet global priorities.

• Serve as an expert on industry best practices, international standards, data privacy laws, anonymization tools, and process and policies supporting clinical document anonymization.

• Manage key internal stakeholders to ensure a cross functionally aligned anonymization approach, including processes, procedures and systems.

• Participate in and coordinate activities in required system testing and validation activities and provide expert input to global data initiatives and networks.

• Provide general support related to anonymization rules updates, validation, and maintenance.

• Contribute to ensuring all team documentation is kept up to date and relevant, including but not limited to guidelines, training materials, and other tools. 

• Participate in forward-thinking efforts around proactive writing of clinical study reports to support automated anonymization.

• Ensure adherence to all applicable Alexion/AZ and external requirements.

• Establish best practice to improve quality, productivity, and effectiveness of Alexion/AZ processes.

• Manage multiple, parallel projects end-to-end to the satisfaction of customers, to get clinical documents into the publishing stage.

• Proactively learn of new policies, legislation, and business processes that arise due to the dynamic and evolving nature of the data and document-sharing landscape.

Required Qualifications

• Excellent organizational skills and ability to balance different projects/priorities and deliver high-quality outcomes under pressure.

• Experienced project manager with well-developed interpersonal, communication, coaching, influencing, and managing skills.

• Knowledge of industry best practices in validated systems landscape.

• Expertise in anonymization rules, methods, and tools supporting anonymized datasets and documents delivery.

• Expertise in risk measurement and quantification of data sets, particularly those used for delivery of EMA Policy 0070 redacted document packages and other regulatory policies globally.

• Experience managing scientific and quality services in collaboration with systems owners and vendors.

• Advanced verbal and written communication skills, and ability to maintain and create professional networks with stakeholders.

• Advanced and proven problem solving, conflict resolution, and change management skills.

• Strong attention to detail, analytical skills, and ability to concisely summarize large amounts of complex information.

• Understanding of the data collected and used in the clinical study lifecycle and how technical programming and information components of a study are delivered, including but not limited to the following:

  • Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) data sets

  • Tables, figures, and listings (TFLs)

  • CTT deliverables (data de-identification, results posting files)

• Demonstrated knowledge of clinical study reports and other clinical documents.

• Desirable knowledge and experience include:

  • Operational excellence and lean principles

  • Design and implementation of data privacy protection solutions and tools

  • Statistical or database programming language (preferably SAS)

  • Medical writing

Education

• PhD in life sciences, statistics, or computer science.

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.