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Associate Director, Clinical Trial Oversight
4 months ago
Responsibilities:
The Associate Director, Clinical Trial Oversight will provide strong leadership and clinical operations experience to support Alnylam's oversight of CRO monitoring effectiveness. The Associate Director, Clinical Trial Oversight will manage Clinical Trial Oversight Leads (CTOLs) and direct the work of FSP CTOLs. This position reports to the Director, Clinical Operations.
Summary of Key Responsibilities:
* Develop, implement, and oversee Alnylam's Clinical Trial Oversight strategy in alignment with ICH GCP E6 and E8
* Lead, direct, and support 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 at all times" mentality
* 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
* Travel on assignment ≤ 50%
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 (e.g. key networks, key trial sites and investigators, key opinion leaders and their site staff
* 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, 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 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.
