Back to jobs
tags.new

VP, Global Trial Optimization

Cambridge, MA

Overview

Alnylam is seeking an experienced leader to drive the strategy and execution of clinical trial optimization across our development portfolio. As Vice President, Global Trial Optimization, you will lead strategic feasibility, protocol optimization, scenario planning, and patient recruitment, retention, and experience initiatives to help accelerate clinical development and improve trial performance.

As a member of the Pipeline Delivery Leadership Team and reporting to the SVP, Pipeline Delivery, you will lead a team that supports all clinical trials across the portfolio. In this role, you will partner across functions to ensure studies are designed and delivered efficiently, using data-driven insights and patient-centered approaches to accelerate the delivery of therapies to patients worldwide.

 

Key Responsibilities 

  • Drives a Feasibility Center of Excellence and partners with our preferred CROs to deliver data driven, accurate and optimal clinical trial scenario plans for country placement, enrollment rates and study timelines; designs and develops feasibility tools and processes
  • Leads country placement discussions at Program Leadership Team and outlines country placement recommendations for clinical trials in support of business and trial needs; represents Clinical Operations at governance forums (e.g.: DevBoard, DOC, PLT) as appropriate
  • Leads the protocol feasibility and scenario modeling and recommends optimized trial delivery strategies for country and site placement, enrollment rates, site identification and trial milestones that inform decision making at governance forums
  • Oversees clinical trial enrollment modeling and identifies the best path to clinical trial patients; models the impact of inclusion/exclusion criteria on enrollment potential and trial timelines
  • Partners with study teams and CROs to provide data driven accurate study timelines, milestone, and enrollment assumptions; leads clinical operations lock (CLOCK) reviews and partners with study team to communicate CLOCK milestones at governance forums
  • Facilitates site identification and outlines best fit site archetype
  • Accountable for predictable and consistent delivery of patient recruitment & retention strategies. Leads identification and selection of portfolio level recruitment strategies and sourcing, with a focus on reduced patient burden and diversity where appropriate
  • Provides robust estimates for the impact of patient recruitment programs on trial enrollment and cost
  • Identifies and analyzes important connections within and across therapeutic areas to optimize study planning and performance at the portfolio level

Qualifications 

  • MSc, MBA, PhD or equivalent in relevant discipline strongly preferred
  • 20+ years industry experience focused on Clinical Operations, including global clinical trial conduct, feasibility, protocol optimization, patient recruitment and retention, and working with global CROs
  • 10+ year team leadership, building strong feasibility and patient recruitment teams
  • Thorough understanding of clinical trial feasibility and scenario planning; including demonstrated experience with supportive tools, technologies, Monte Carlo simulations etc. Proven experience in data analysis, data interpretation to drive informed decision making
  • A thorough understanding of the processes associated with feasibility, protocol optimization, site identification, patient recruitment and retention
  • Extensive experience in patient recruitment campaigns
  • Demonstrated ability to deliver results and achieve objectives within budget and timeline constraints. Proven experience in cost optimization and reduction
  • Extensive experience in pharmaceutical/biotechnology and extensive knowledge of drug development processes, ICH-GCP guidelines, 21 CRF Part 11, and major Health Authority regulations as they pertain to the operational aspects of clinical trials
  • Comfortable working with Senior Executive Teams
  • Well networked with industry peers
  • Strong project management skills and effective matrix leader. Able to hold teams accountable to deliverables
  • Ability to travel up to 30%
  • Thrives in highly entrepreneurial biotech environment and embraces Alnylam’s culture of science, passion, and urgency
  • Clear alignment with Alnylam Core Values
    • Commitment to People
    • Fiercely Innovative
    • Purposeful Sense of Urgency
    • Open Culture
    • Passion for Excellence 

 

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

$301,800 - $408,200 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...
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 Status

Invitation to Self Identify
EEO is the Law Poste

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.

Select...