SVP, Clinical Operations

Overview

The Senior Vice President of Clinical Operations will be accountable for leading and continuing to build our Clinical Operations function to advance Alnylam’s growing portfolio of RNAi therapeutics through clinical development across a wide range of diseases. In addition to assuming responsibility for both the strategic direction and tactical execution of global clinical trials across all stages of development, this senior leader will be responsible for selecting and managing clinical CROs and vendors, ensuring rigorous quality in trial conduct, and be an enterprise leader involved in capability build and process improvement throughout the Company.

Currently, the team has over 80 clinical operations professionals located primarily in Cambridge, MA and Maidenhead, UK and works closely with several strategic CRO partners to design and execute clinical trials. In addition to direct study facing personnel, the Clinical Operations team function includes groups focused on Patient Recruitment & Retention, Trial Master File, and Clinical Trial Oversight & Systems. The team will continue to grow to manage an expanding clinical portfolio around the globe. This position reports directly to the Chief Development Officer and will work in close partnership with our heads of Clinical Research, Data Science and Statistics, Medical Writing, Regulatory, Clinical Pharmacology, Quality and Procurement. They will be a member of the Operating Team of the Company and key governance committees responsible for strategic oversight of product development plans and study protocols. As such, we expect this leader to bring their integrated knowledge of drug development and clinical operations strategy and execution to bear on helping us advance RNAi therapeutics to patients in need.

The successful applicant will have the ability to develop strategy while remaining very hands-on, given our entrepreneurial biotech culture and will be a key member of the Development organization and work in a vibrant culture, thriving on science, passion, and urgency.

Key Responsibilities

• Be the senior strategic and operational leader for Clinical Operations providing a strong, clear voice both internally and externally, demonstrating an inspirational and entrepreneurial mindset
• Partner with internal stakeholders to integrate clinical operations knowledge and expertise into all applicable clinical development activities, including product development plans and study protocols
• Build and maintain relationships with both internal and external partners such as our broader development organization, procurement function and Contract Research Organizations (CROs)
• Set strategic direction for clinical outsourcing and oversight; provide leadership in CRO and vendor selection and management; establish and maintain strong relationships with CROs, external experts and investigators to ensure effective and timely execution of internal and external clinical projects
• Ability to provide strategic direction in clinical trial design for Phase 1- Phase 3 trials in rare and prevalent diseases
• Grow, direct, and support the operations of a global function supporting all of our clinical phase programs
• Lead a globally dispersed team towards a common vision and set of related goals
• Build a world-class operations team by attracting talent, developing staff to grow into roles of increasing scope and seniority and maintaining a culture of engagement and drive.
• Optimize time, quality, and cost of Clinical Trials across all stages of development
• Be accountable for clinical trial timelines and deliverables
• Ensure all relevant SOPs and systems/ processes are in place and optimized to ensure an efficient and compliant organization that is inspection ready
• Evaluate, select, and manage Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation while adhering to FDA, EMEA, GCP, and ICH guidelines
• Ability to be forward-thinking, innovative and scale organizations
  
  

Qualifications

• BS degree in Life Sciences. PhD, MBA, or equivalent is strongly preferred
• 15+ years industry experience focused in Clinical Operations, ideally including global experience
• Experience leading and growing a broad team of clinical operations specialists, ideally globally, with a history of attracting, retaining, and developing staff
• Direct knowledge of and experience in dealing with external alliance partners
• Proven ability and history of establishing and maintaining strong alliance relationships with biotech/pharma partners
• Outstanding leadership and collaboration skills working within a matrix environment
• Comfortable working with Senior Executive Teams, joint steering committees with vendors and on occasion with Board members
• Thrives in highly entrepreneurial biotech environment, with prior experience in a small/medium size company an advantage
• Experience in managing complex vendor relationships
• Experience in trial oversight, data management, financial planning, and controls.
  
  

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 the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, 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. 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.