Global Study Lead

Alnylam Pharmaceuticals; Maidenhead; Hybrid; GBP 90,000 - 120,000; Full time

Job summary

Alnylam Pharmaceuticals is seeking a Global Study Lead (Sr. Manager, Clinical Operations) to lead the operational planning and execution of global clinical trials from start-up to closeout.

You will provide leadership to cross-functional trial teams, ensuring trials are on time, within budget, and compliant with GCP and company procedures. This hybrid role is based in Maidenhead, with exceptional candidates considered for remote work.

Qualifications

• BS/BA degree required.
• 7+ years clinical research experience in CRO/biotech/pharma.
• 3-5 years leading global Phase 1-4 trials including Phase 3 registrational.
• Experience managing trials outsourced to CRO and budgets.
• Strong leadership, analytical, and financial management skills.
• Ability to mentor and lead cross-functional teams.
• Excellent planning, communication and presentation skills.
• Proficiency with MS Office and MS Project.

Responsibilities

• Lead cross-functional trial teams to develop and execute operational plans.
• Own trial-level delivery including timelines and budgets.
• Oversee CRO/vendor selection, onboarding, contracting, and performance.
• Identify operations risks and ensure milestones met.
• Ensure compliance with global regulations and GxP.
• Support Health Authority Inspections and QA audits.
• Drive continuous improvement in study execution and cross-functional collaboration.
• Mentor Study Management colleagues.
• Interface with key stakeholders across Finance, Regulatory, Data Management, etc.
• Provide variance analysis of budget-to-actuals.
• Provide operational updates to governance forums.
• Travel ~10% with flexibility.

Skills

Leadership

Cross-functional collaboration

Budget management

Project planning

MS Office Suite

MS Project

Stakeholder management

Problem-solving

Education

BS/BA degree

Tools

MS Project

MS Office Suite

Job description

Overview

The Global Study Lead (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.

Overview

The Global Study Lead (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.

This is a hybrid role based in Maidenhead. However, for exceptional candidates, remote working arrangements may also be considered.

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.