Global Study Lead

Alnylam Pharmaceuticals; United States; On-site; USD 145,000 - 196,000; Full time

Job summary

Alnylam Pharmaceuticals seeks a Sr. Manager, Clinical Operations to lead the planning and execution of global clinical trials from start-up through closeout.

You will guide cross-functional teams to meet timelines, budgets, and regulatory requirements, while mitigating risks and upholding quality across programs. You will mentor Study Management colleagues, coordinate with Finance, Quality, Data Management, and Regulatory, and drive continuous improvement in trial delivery and collaboration.

Qualifications

• BS/ BA degree is required.
• Minimum 7+ years of clinical research experience with CRO, Biotech or Pharmaceutical Company on Phase 1-4 trials.
• 3-5 years leading end to end global clinical trials including Phase 3 registrational trials.
• Experience leading global trials outsourced to a CRO and managing all aspects of trial execution.
• Excellent decision-making, analytical and financial management skills.
• Strong leadership, collaboration, and ability to operate with limited supervision.
• Proven track record of cross-functional influence in global matrix organizations.
• Experience mentoring/ coaching others.
• Excellent organizational, prioritization and problem solving abilities.
• Proficient with MS Office Suite (Excel, Word, PowerPoint) and MS Project.

Responsibilities

• Lead cross-functional trial teams to develop and execute study operational plans and deliver end-to-end trial execution.
• Accountable for trial-level delivery including timelines, budget, quality oversight, milestones and deliverables.
• Oversee CRO and vendor selection, onboarding, contracting, budget management and monitoring.
• Identify operational risks and ensure mitigations and contingencies are initiated.
• Ensure trials comply with global regulations, GCP and internal procedures.
• Participate in Health Authority inspections and internal QA audits.
• Maintain inspection-readiness with R&D Quality oversight.
• Drive continuous improvement in study execution, efficiency, quality and collaboration.
• Mentor Study Management colleagues and share best practices.

Skills

Cross-functional leadership

Budget management

Risk management

Project planning

Communication

MS Office & MS Project

Education

BS/BA degree

Tools

MS Office

MS Project

Job description

The Sr. Manager, Clinical Operations is responsible for leading the operational planning and execution of global clinical trials from study start-up through closeout. This role provides leadership to cross-functional trial teams, ensuring trial objectives are achieved on time, within budget, and in compliance with applicable regulations, Good Clinical Practice (GCP), and company procedures. The Sr. Manager identifies and mitigates operational risks, drives alignment across stakeholders, and delivers high-quality trial execution in support of development program goals.

Summary Of Key Responsibilities

• Lead cross-functional trial teams to develop and execute study operational plans and deliver successful end-to-end trial execution.
• Accountable for trial-level delivery, including timelines, budget management, quality oversight, key milestones, and critical study deliverables.
• Oversee CRO and vendor selection, onboarding, contracting, budget management, performance monitoring, and issue resolution to ensure successful study delivery.
• Proactively identify operations risks and ensure that trial deliverables and milestones are met according to corporate and study-level goals.
• Identify risks and ensure mitigations and contingencies are being initiated and followed through.
• Ensure trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes.
• Participate in preparation for, and conduct of, Health Authority Inspections and internal QA audits
• Ensure that the trial team operates in a constant state of inspection-readiness, collaborating with R&D Quality to ensure quality oversight
• Contribute to continuous improvement initiatives by identifying opportunities to enhance study execution, operational efficiency, quality, and cross-functional collaboration.
• Mentor and support onboarding and development of Study Management colleagues, sharing best practices and lessons learned across teams.
• Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups.
• Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure.
• Prepare and provide operational updates, risks, and recommendations to governance forums, leadership teams, and cross-functional stakeholders.
• Ability to travel approximately 10% but flexibility to go over or below as per business need.

Qualifications

• BS/ BA degree is required.
• Minimum 7+ years of clinical research experience gained with a CRO, Biotech or Pharmaceutical Company working on Phase 1-4 global clinical trials.
• 3-5 years leading end to end global clinical trials with experience in conducting Phase 3 registrational trials
• Experience leading global trials outsourced to a CRO and ability to manage all aspects of execution of a clinical trial
• Excellent decision-making, analytical and financial management skills are essential to this position
• Excellent leadership skills, proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervision
• Demonstrated success leading cross-functional teams in global matrix organizations and achieving results through influence.
• Experience mentoring/ coaching others
• Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.
• Strong project planning/ management, communication (written and verbal) and presentation skills
• Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.

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.

Before applying, please review Alnylam's Candidate Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.

The pay range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

U.S. Pay Range

$144,500 - $195,500 USD