Global Study Lead

Alnylam Pharmaceuticals; Philadelphia (Philadelphia County); Hybrid; USD 145,000 - 196,000; Full time

Benefits offered by this job

Medical, dental, and vision

401(k) match

Paid time off

Job summary

Alnylam Pharmaceuticals in Cambridge, MA or Philadelphia, PA is seeking a Global Study Lead to orchestrate operational planning and execution of global clinical trials from start-up to closeout. You will lead cross-functional teams, ensure trials meet timelines, budget, and quality standards, and mitigate risks in line with GCP and company SOPs.

This hybrid role requires strong leadership and program management skills, experience with Phase 1-4 trials and CRO oversight, and the ability to travel

Qualifications

• Minimum 7+ years of clinical research experience with CRO/biotech/pharma.
• 3-5 years leading end-to-end global clinical trials including Phase 3.
• Experience leading global trials outsourced to a CRO and managing all aspects.

Responsibilities

• Lead cross-functional trial teams to develop and execute study operational plans.
• Oversee trial delivery timelines, budget, quality, milestones and deliverables.
• Manage CRO/vendor selection, onboarding, contracting and performance.
• Identify and mitigate operational risks and ensure milestones are met.
• Ensure regulatory compliance and health authority inspections readiness.
• Provide updates and recommendations to governance and stakeholders.
• Travel approximately 10%, with flexibility as needed.

Skills

Leadership

Cross-functional

Budget management

GCP compliance

Risk management

Project planning

Communication

Regulatory knowledge

Inspection readiness

Education

BS/ BA degree

Tools

MS Office Suite

MS Project

Job description

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 preferably based in Cambridge, MA or Philadelphia, PA. However, for exceptional candidates, remote working arrangements may also be considered.

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.

U.S. Pay Range

$144,500.00 - $195,500.00

The pay range 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

About Alnylam

We are the leader in RNAi therapeutics– a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.