Senior Manager, Standards, Process & Training

Reporting to the Associate Director of Standards, Process & Training - Clinical Development, the Sr Manager, GCP Process Managementserves as a process excellence Subject Matter Expert (SME) on process improvement, management and effectiveness. The role is responsible for the life-cycle management of controlled procedural documents (e.g., Standard Operating Procedures, Work Instructions) and managed documents (e.g., tools, guidelines) related to GCP and clinical trials. The role is responsible for facilitating process development, review, approval, training and effectiveness checks and ensuring alignment with GCPs, regulations and laws. This role partners with Expertise Areas (EAs) across Development to drive the consistent application of standards and promotes a culture of sustainable compliance, continuous improvement, and inspection readiness. In addition, the role leads and participates in initiatives aimed at innovation, quality, continuous process improvement and efficiency that align with organizational strategies and goals.

Summary of Key Responsibilities.

• Process Strategy, Governance & Portfolio Leadership
• • Leads the development, periodic review, and continuous improvement of GCP and clinical trial-related processes across Clinical Development.
  • Owns the clinical process development portfolio, including prioritization, sequencing, and resourcing of initiatives in alignment with business strategy and risk.
  • Establishes and evolves process governance frameworks, standards, and best practices to ensure consistency and scalability.
• Cross-Functional Partnership & Influence
  • Drives or consults on the identification and implementation of process related change management needs
  • Drives maintenance of the Process Portal to ensure easy access to the end-to-end clinical trial-related process families
  • Partners with Process SMEs and Operational Effectiveness to implement process revisions identified in effectiveness checks
  • Partners with EAs to proactively identify learning gaps; seek out, identify, and drive process improvements with a focus on standardization
  • Drives process inspection readiness
  • Consulting on CAPAs/Quality Events related to clinical trial processes
• Additional support may include:
  • Represent Process Excellence by leading and/or participating in working groups and initiatives that drive the healthy conduct of clinical trials and helps the business scales for the future

Qualifications

• University Degree in Science and/or a relevant discipline.
• Minimum 8+ years experience with a biopharmaceutical company and/or CRO and a track record of success in global clinical development or related disciplines including:

• • Extensive experience in activities related to process improvement; SOP development and review, role-based curriculum management
  • Proven ability to design/evolve and implement GCP related processes (e.g., SOPs, Work Instructions) in a fit-for-purpose manner enabling effectiveness, flexibility and adaptability in a dynamic business model
  • Experience in global clinical study/site management
  • Understanding of the processes required to operationally execute clinical trials to a high standard of excellence

• Strong knowledge of GCP, global regulatory and compliance requirements for clinical trials.
• Knowledge of industry trends and best practices for process quality, efficiency, compliance, and effectiveness.
• Knowledge of Process Mapping strategies and tools strongly preferred
• Knowledge of managing within EDMS and LMS systems
• Demonstrated ability to coach, motivate and influencehigh performing colleagues across areas to deliver
• Ability to execute work independently and with minimal supervision
• Ability to respond to change with agility, resilience, innovation, and optimism, seeking solutions based on creative problem solving, lessons learned and well-reasoned risk taking
• Detail oriented & possess technical expertise
• Strong communication (written, verbal, presentation) and analytical skills
• Able to accommodate limited travel (may include international travel) according to business need (~10%)

• Alignment with Alnylam's Core Values: Fiercely Innovative, Open Culture, Purposeful Urgency, Passion for Excellence, Commitment to People

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U.S. Pay Range

$140,300.00 - $189,700.00

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

AboutAlnylam

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.