Back to jobs
New

Global Study Lead

Cambridge, MA or Philadelphia, PA

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.

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

We are the leader in RNAi therapeutics – a revolutionary approach 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 possible and 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, where an authentic, inclusive culture and breakthrough thinking fuel 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.

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

Create a Job Alert

Interested in building your career at Alnylam Pharmaceuticals? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Select...
Select...
Select...
Select...
Select...
Select...
Select...

*Note: Fixed Term Contractors please apply via the Internal Careers page

Select...
Select...

State Specific Applicant Notices

  • Arizona Applicants: To the extent required by applicable law, the Company maintains a smoke-free workplace.
  • Maryland Applicants:
    • UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
    • The Company considers this Application for Employment to be a part of the personnel record.
  • Massachusetts (MA) Applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
  • Rhode Island (RI) Applicants: The Company is subject to Chapters 29-38 of Title 28 of the General Laws of Rhode Island, and is therefore covered by the state's workers' compensation law.
Select...

I understand the Company may obtain, without using the services of a third party investigative consumer reporting agency, public records pertaining to my character, general reputation, personal characteristics or mode of living during its evaluation of my application for employment and, if employed, during my employment.  

Select...

I acknowledge that I have read and understand the California Applicants Notice set forth above and confirm that I waive my right to receive copies of public records obtained by the Company under California Civil Code section 1786.53. 

Select...

Acknowledgement 

I have read and fully understand the questions asked in this application.  I certify that all of the answers I have given are true, accurate and complete.  I understand that the falsification, omission and/or misrepresentation of any fact from or on this application or during any interview will result in immediate rejection of my application or if I am hired will be cause for immediate dismissal.  I authorize the Company and its agents, including consumer reporting agencies, to independently inquire about, investigate and obtain copies of any records which relate to me from my former employers and educational institutions, and otherwise verify any of the information provided by me during the application process.  To the fullest extent allowable under applicable law, I hereby release the Company and all affiliated persons and entities, as well as any person or institution that provides the Company with any lawful information about me, from any and all liability whatsoever resulting from any such lawful independent inquiry, investigation or communication.

If hired, I understand that I will be required to abide by all of the rules and regulations of the Company.  I understand that nothing in this application shall constitute an offer, a contract or a guarantee of employment for a specific period of time.  If hired, I understand that my employment may be terminated with or without cause and with or without notice at any time, at the will of the Company or me, unless otherwise provided by applicable law.  I further understand that no representative or agent of the Company, other than the Chief Human Resources Officer has the authority to enter into any agreement for employment, on an individual or collective basis, for any specific period of time, or to make an agreement contrary to the foregoing.  I also understand that any agreement modifying at-will employment status, on an individual or collective basis, must be in writing and signed by the Chief Human Resources Officer.  In addition, I understand that the Company and all plan administrators shall have the maximum discretion permitted by law to administer, interpret, modify, discontinue, enhance or otherwise change all policies, procedures, benefits or other terms and conditions of employment.

US - Voluntary Self-Identification of Veteran & Disability Status

Invitation to Self Identify
EEO is the Law Poster
Voluntary Self-Identification of Veteran Status

Why are you being asked to complete this form?

A "disabled veteran" is one of the following:

A veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or

A person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to.

Protected veterans may have additional rights under USERRA—the Uniformed Services Employment and Reemployment Rights Act. In particular, if you were absent from employment in order to perform service in the uniformed service, you may be entitled to be reemployed by your employer in the position you would have obtained with reasonable certainty if not for the absence due to service. For more information, call the U.S. Department of Labor's Veterans Employment and Training Service (VETS), toll-free, at 1-866-4-USA-DOL.

If you believe you belong to any of the categories of protected veterans listed above, please indicate by checking the appropriate box below. As a Government contractor subject to VEVRAA, we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA.

Submission of this information is voluntary and refusal to provide it will not subject you to any adverse treatment. The information provided will be used only in ways that are not inconsistent with the Vietnam Era Veterans' Readjustment Assistance Act of 1974, as amended

The information you submit will be kept confidential, except that (i) supervisors and managers may be informed regarding restrictions on the work or duties of disabled veterans, and regarding necessary accommodations; (ii) first aid and safety personnel may be informed, when and to the extent appropriate, if you have a condition that might require emergency treatment; and (iii) Government officials engaged in enforcing laws administered by the Office of Federal Contract Compliance Programs, or enforcing the Americans with Disabilities Act, may be informed.

Voluntary Self-Identification of Disability (Form CC-305 / OMB Control Number 1250-0005 / Expires: 04/30/2026)

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .

How do I know if I have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

Alcohol or other substance use disorder (not currently using drugs illegally)
Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
Blind or low vision
Cancer (past or present)
Cardiovascular or heart disease
Celiac disease
Cerebral palsy
Deaf or serious difficulty hearing
Diabetes
Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
Epilepsy or other seizure disorder
Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
Intellectual or developmental disability
Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
Missing limbs or partially missing limbs
Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
Neurodivergence, for example, attention-deficit/hyperactivity disorder(ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
Partial or complete paralysis (any cause)
Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
Short stature (dwarfism)
Traumatic brain injury

Select...
Select...