The Vice President, Study Management is a study management and execution subject matter expert and accountable for the delivery of studies within the assigned portfolio. The Vice President, Study Management provides strategic input and clinical operations expertise to inform overall program strategy.

The Vice President, Study Management is a member of the Clinical Operations Leadership Team and accountable for building and ensuring therapeutic area, functional and technical study management expertise within their group, as well as people management. The Vice President, Study Management collaborates with other study management leads and is accountable to build the study management discipline within Clinical Operations, develops standards and best practices to be implemented across all studies, and works to balance study management resources across the portfolio. Reporting to the SVP, Clinical Operations, the Vice President, Study Management will lead a team of > 30 individuals and be accountable for clinical trials in the assigned Development portfolio.

Key Responsibilities

• Leads a complex portfolio of assets and therapeutic areas

• Accountable for the delivery of clinical trials (quality, speed, cost) within assigned portfolio and oversees study plans; drives strategic and operational leadership across multiple clinical programs ensuring appropriate clinical operations strategy, scope, timelines, quality, risk management, budgets, and compliance with regulatory guidelines

• Serves as the point of contact for Executive & Program Team Leaders, Expertise Areas and Clinical Operations leads for assigned assets and therapeutic areas, including preparation of content for governance meetings, regulatory submissions, investment planning and goal setting; leads clinical operations discussions at program forums (e.g. CDST)

• Accountable for optimized clinical trial delivery plans within assigned portfolio that inform decision making at governance forums and support business and trial needs; represents Clinical Operations at governance forums (e.g.: DevBoard, DOC, PLT) and key alliance partnership meetings (e.g. JSC) as appropriate

• Facilitates site identification and outlines best fit site archetype; collaborates with key internal and external stakeholders on clinical trial site relationship management

• Partners with Global Trial Optimization and CROs to provide data driven accurate study timelines, milestone, enrollment and cost assumptions; accountable to meeting clinical operations lock (CLOCK) milestone and partners with Global Trial Optimization to communicate CLOCK milestones at governance forums

• Accountable for relevant corporate goals and ensures they are met to specification; actively monitors progress on goals and priorities, including overseeing effective dashboard input

• Accountable for CRO/vendor performance on assigned portfolio; oversees relevant vendor key performance/quality indicators, identifies and resolves program/study level issues and escalates as appropriate

• Accountable for clinical trial budget and management for assigned portfolio

• Accountable for clinical trial resourcing, setting priorities and managing operational plans and budgets

• Accountable for actuate investment and long-range plans; anticipates future needs and resources

• Accountable for building clinical operations, therapeutic area, and technical skills within team to ensure patient safety, quality clinical trial execution and effective delivery of trials (cost, speed); serves as an expert in clinical operations processes and formulates strategies, standards, processes, and best practices for clinical trial conduct

• Lead the of hiring, performance management, and succession planning of direct reports and their teams

• Participates in developing the overarching strategy for the Clinical Operations with other Clinical Operations Leadership Team members

• Leads the development and implementation of Study Management standardizations where appropriate while retaining a level of flexibility that allows for speed of execution and creative innovations in collaboration with other COLT members

• Ensure effective external partnerships with study sites, investigators, KOLs, pharma trade associations, and alliance partnerships

• Leads strong interaction with local country, medical affairs teams/regional medical groups and other strategic partners as needed for the successful delivery of clinical trials

• Collaborates with vendor/CRO partners, internal groups in the development of and compliance with robust inspection readiness plans to ensure high quality clinical trial conduct and data integrity

• MSc, MBA, PhD or equivalent in relevant discipline strongly preferred

• Extensive (20+ years) drug development experience with a biopharmaceutical company and track record of success in global clinical operations

• Significant (10+ years) experience in study management and team leadership, including leading global and remote based clinical trial teams; must have extensive experience managing global CROs

• Extensive experience in the clinical drug development process including clinical program planning, clinical trial startup through final study report

• A thorough understanding of the financial aspect associated with clinical trials with a proven track record in clinical trial resource planning forecasting, and budgeting

• Comfortable working with Senior Executive Teams

• Ability to understand and respond to multiple external and stakeholder needs, manage and handle conflict constructively required

• Significant 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

• 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

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 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 the #1 Large Employer by Boston Globe Top Places to Work in 2022, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2023 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.

Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law. Alnylam is an E-Verify employer.