Clinical Trial Oversight Director

4 weeks ago

Cambridge, Massachusetts, United States Alnylam Full time
Job Summary:

The Associate Director, Clinical Trial Oversight will provide leadership and clinical operations experience to support Alnylam's oversight of CRO monitoring effectiveness. This position reports to the Director, Clinical Operations.

Key Responsibilities:

Develop and implement Alnylam's Clinical Trial Oversight strategy in alignment with ICH GCP E6 and E8

Lead and direct Clinical Trial Oversight Leads (CTOLs) in assessing CRO monitoring effectiveness across the portfolio

Direct day-to-day work activities for FSP vendor for Clinical Trial Oversight

Consistently manage oversight activities at the program level as aligned, and ensure Study Specific Oversight Plans are appropriately implemented and followed for all studies within scope

Drive a culture that balances purposeful urgency with passion for excellence, employ risk-based thinking to focus on what is critical to quality, and emphasize an inspection-ready mentality at all times

Develop and maintain effective working relationships with stakeholder functions to achieve Clinical Operations' goals

Assist in planning and trial optimization to evolve the Clin Ops organization as we scale for the future

Participate in various workstreams and projects as a leader in Clinical Operations to improve and refine processes

Ensure CTOLs complete administrative tasks on time and facilitate their continuous development

Determine resourcing needs within oversight and workload allocation based on the portfolio

Support inspection preparation and management

Maintain awareness of changes in industry and regulatory standards for GCP requirements and share updates with CTOLs

Requirements:

Bachelor's Degree is required. A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD) is preferred

Previous experience in Oversight and/or Oversight Line Management preferred

Proven experience in effectively leading teams and regional remote-based staff

Solid direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/CRA management experience preferred

Experience in all study phases of clinical research (Phase I-IV) and experience in rare medical conditions preferred

Previous regulatory inspection experience preferred

Comprehensive and current regulatory knowledge, including GCPs

Skills:

Ability to concisely present significant issues and criticality to senior leaders

Excellent interpersonal, verbal, and written communication skills, including experience in making presentations at conferences, meetings, and training sessions

Ability to build and maintain relationships with key investigators and sites

Innovator, willing to initiate changes, introduce new ideas, and creatively problem-solve

Experience with Microsoft-based applications and ability to learn internal computer systems

Effective leader and collaborator with the ability to work consistently, flexibly, and adjust to changing priorities in a fast-paced environment

Effectively manage and develop others to be successful at Alnylam and meet the needs of Clinical Trial Oversight and the broader organization

Analyze complex situations and effectively communicate issues along with potential recommendations to various functional groups

Demonstrate good judgment and decision-making experience

Ability to delegate tasks and oversee delegated activities

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 people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people. 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 the #1 Large Employer by Boston Globe Top Places to Work in 2022, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2023 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.

Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law. Alnylam is an E-Verify employer.

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