Associate Director, Clinical Risk and Analytics

Overview

The Associate Director, Clinical Risk & Analytics (CR&A) is responsible for coordinating and overseeing the cross-functional risk management and central monitoring activities for their direct reports and their own assigned Alnylam clinical trials in accordance with ICH GCP E6 requirements. The associate director has comprehensive knowledge of study management, data management, site monitoring and/or clinical science process that can be applied to identify issue/risks and lead clinical study team’s and their CR&A team members to apply effective and efficient mitigations and monitoring strategies.

Responsibilities

The AD Clinical Risk & Analytics (CR&A) will.

• Lead, develop, coach, and manage members of the global Clinical Risk & Analytics (CR&A) team.
• Responsible for managing, maintaining and updating their assigned portion of the RBQM framework (e.g. training, processes, documentation, system(s)) for CR&A
• Assists in creating and driving the vision and operating model of RBQM+ in Clinical Development
• Acts as RBQM Lead on assigned trials(s), including the development of the Risk Management and Action Plan (Risk MAP), RBQM Plan, Integrated Data Quality Plan (IDQP), and Targeted SDV and SDR planning on assigned trials.
• Along with the Director of CR&A develop and maintain appropriate metrics, dashboards and communication tools regarding RBQM.
• Delivers and ensures delivery of timely and high-quality RBQM system analytic summaries reports and communicate findings to the cross-functional study teams and CRO.
• Ensure inspection readiness for clinical risk management and centralized monitoring activities on their team and their own assigned studies
• Provide insight to Alnylam and CRO study team on best practices of risk management, vendor oversight, and Centralized Monitoring.
• Train and Mentor CR&A and/or Clinical Development team in risk management and centralized monitoring as needed
• Guide teams on inspection readiness and study risk preparation in the event of a regulatory authority audit in partnership with QA. Interface with regulatory inspectors, as needed.
• Coordinate, lead and participate continuous improvement activities in CR&A and beyond, as required
• Demonstrate clear alignment with Alnylam Core Values including, Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture and Passion for Excellence.

Requirements

• Proven experience in a clinical research environment.
• Bachelor's Degree is required, an advanced degree (MS, MA, MBA, PharmD) is preferred
• Previous experience in study management, site monitoring, data management, risk Management and or centralized monitoring preferred
• Proven experience in effectively leading and managing teams and globally based staff
• Solid direct risk management and process development experience gained with a CRO or pharmaceutical company working on multinational clinical studies.
• Experience in all study phases of clinical research (Phase I-IV) preferred
• Experience Building, developing, and maintaining good working relationships with internal and external customer groups.
• Have strong aptitude for data analytics, mathematical and statistical concepts.
• Experience and understanding of Risk Based Monitoring and Site Profiling Tools preferred.
• Experience with and good understanding clinical data
• Previous regulatory inspection experience preferred.
• Comprehensive and current regulatory knowledge, including Good Clinical Practice/ICH E6 Guidelines and/or other applicable regulatory requirements.
• Experience and understanding of clinical trial data from various sources (e.g., Clinical devices, SDTM, RAVE, IRT, etc)
• Ability to work collaboratively in a team environment whilst managing changing priorities to achieve goals/targets.
• Excellent leadership and organizational skills and ability to deal with competing priorities
• Excellent Project management capabilities
• Effective communication skills (written, verbal and presentation)

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.