Associate Director, Early Development Quality

Overview

The Associate Director, Early Development Quality provides strategic, upstream quality leadership across nonclinical development programs, with a focus on de-risking study design, biomarker strategies, and external laboratory partnerships to protect downstream clinical and regulatory outcomes. The position leads risk-based oversight of external laboratories and vendors in alignment with GLP, OECD, and global regulatory expectations, while proactively identifying and mitigating risks that could impact data integrity, inspection readiness, or agency review during IND and NDA submissions.

This role partners closely with Research, Nonclinical, Biomarker, Bioanalytical, Regulatory, and Clinical Quality stakeholders to embed quality and risk management early in program strategy and execution.

This position will be located within the US and can be hybrid, onsite, or remote.   

Key Responsibilities

• Sets the strategic quality oversight direction for internal and outsourced laboratory activities supporting nonclinical development (GLP and non-GLP), including toxicology, bioanalytical, and biomarker data supporting IND, CTA, and NDA submissions.
• Provides upstream scientific and quality risk oversight for nonclinical programs by partnering with Research, Nonclinical Project Teams, Biomarker, Bioanalytical, Regulatory, and Nonclinical Writing functions to evaluate study strategies, contribute to protocol design, and proactively identify risks that could impact data integrity, translational interpretation, or downstream clinical and regulatory outcomes.
• Acts as a strategic quality partner in biomarker development and evaluation, ensuring fitness for purpose, analytical robustness, and data integrity to de-risk nonclinical studies and reduce the likelihood of downstream GCP or regulatory challenges.
• Establishes and maintains quality oversight of external laboratories and vendors (e.g., test facilities, CROs, specialty labs, bioanalytical and biomarker partners, clinical laboratories) through risk-based qualification, governance, ongoing performance monitoring, and surveillance.
• Leads the design and execution of a global, risk-based vendor oversight and audit strategy aligned with GLP, OECD, ICH, and regulatory expectations, ensuring that qualification, surveillance, and audit planning are driven by inherent and emerging risk.
• Develops and maintains structured risk identification frameworks for new and existing vendors, enabling consistent qualification decisions, defensible oversight, and inspection-ready documentation.
• Serves as an upstream risk intelligence partner to R&D Quality and Regulatory functions, translating nonclinical and GLP risks into potential agency questions, inspection vulnerabilities, and mitigation strategies relevant to IND and NDA submissions.
• Leads quality governance and escalation for GLP vendor-related issues, including oversight of quality events, investigations, CAPAs, and executive-level risk visibility as appropriate.
• Provides strategic quality input into CRO and vendor operating models, evaluating process maturity, data governance, systems, and opportunities to strengthen compliance, inspection readiness, and operational effectiveness.
• Advises on continuous improvement of the Quality Management System to better support early development and research activities while maintaining regulatory robustness.
• Partners with Legal and Procurement to ensure contracts and agreements appropriately reflect GLP/OECD obligations, oversight expectations, data integrity requirements, and inspection readiness responsibilities.

Qualifications

• Educated preferably in life sciences (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or work experience. Master’s degree in a science, technology or industry related discipline, preferred.
• Minimum of 10 years of relevant experience, inclusive of bioanalytical and toxicology subject matter, as it relates to GLPs, GCPs and GCLPs.
• Direct experience in the field of assay development and validation and familiar with biomarker-based assays (e.g., PCR, ELISA, FISH) is preferred.
• Prior experience in risk-based thinking, quality assurance, auditing, managing quality issues/escalations, or other relevant QMS elements.
• Prior expertise in global GLP, GCP, GCLP regulations and guidance across regulatory bodies such as FDA, PMDA, European Union, MHRA, etc.

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U.S. Pay Range

$164,500.00 - $222,500.00

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 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.