Senior Director, Nonclinical Toxicology & Strategy

Alnylam Pharmaceuticals; Cambridge (MA); Hybrid; USD 223,000 - 314,000; Full time

Job summary

Alnylam Pharmaceuticals is seeking a Senior Director of Toxicology to provide strategic nonclinical safety leadership across multiple programs. This role shapes development strategies, oversees GLP/non-GLP toxicology studies, and guides risk assessment and regulatory interactions to inform portfolio decisions.

Based in Cambridge, MA with hybrid onsite work, the candidate will mentor scientists, collaborate with Early Development and R&D leaders, and maintain regulatory and industry knowledge to

Qualifications

• PhD in Toxicology or an advanced degree in a related scientific discipline. Board certification ideal.
• Twelve (12) or more years of relevant pharmaceutical or biotechnology industry experience supporting nonclinical drug development from discovery through registration.
• Demonstrated ability to independently lead complex development programs and influence scientific, program, and portfolio decisions in a matrixed organization.
• Deep expertise in nonclinical safety assessment across the drug development lifecycle, including the development and execution of strategies supporting global regulatory submissions.
• Extensive knowledge of applicable global regulatory guidance and standards, including FDA GLP, OECD, and ICH requirements.
• Experience selecting, engaging, and providing scientific oversight of contract research organizations.
• Ability to integrate and interpret complex data across toxicology, pathology, DMPK, safety pharmacology, and related disciplines and to develop thoughtful solutions when results are ambiguous.
• Excellent written, verbal, and presentation skills, with the ability to communicate complex scientific and regulatory topics clearly to project teams, senior leaders, external partners, and regulatory authorities.
• Demonstrated ability to guide, mentor, and develop scientists.

Responsibilities

• Lead integrated, phase-appropriate nonclinical safety strategies across multiple development programs or a therapeutic area or platform, working independently and, where applicable, through direct reports.
• Serve as the senior Toxicology and early development representative on cross-functional teams, providing scientific and strategic leadership for development candidates from discovery through registration.
• Guide the evaluation, integration, and communication of nonclinical risks, mitigation strategies, and potential clinical relevance.
• Provide strategic direction across nonclinical safety assessment, including investigative and general toxicology, safety pharmacology, developmental and reproductive toxicology, and carcinogenicity evaluations, as appropriate.
• Provide scientific leadership for the design, conduct, interpretation, and reporting of GLP and non-GLP toxicology studies conducted at contract research organizations, in partnership with the study monitoring group.
• Maintain current knowledge of industry trends and global regulatory requirements to support the delivery of scientifically rigorous nonclinical safety packages for regulatory submissions, including INDs, CTAs, NDAs, BLAs, and MAAs.
• Represent Toxicology in interactions with global health authorities, as appropriate.
• Translate complex nonclinical findings into clear scientific and business considerations that inform program and portfolio decisions.
• Recruit, onboard, mentor, and develop scientific talent, as appropriate, while fostering an inclusive, collaborative, and high-performing environment.
• Partner with Early Development and Toxicology leadership to strengthen scientific practices, policies, and procedures governing toxicology research.
• Maintain clear communication with leadership regarding program activities, scientific risks, resource considerations, and team priorities.

Skills

Nonclinical safety

Leadership

Regulatory strategy

GLP/ICH knowledge

Mentoring

CRO oversight

Data integration

Communication

Education

PhD in Toxicology

Board certification ideal

Job description

Alnylam Pharmaceuticals is seeking a Senior Director of Toxicology to provide strategic nonclinical safety leadership across multiple programs. This role shapes development strategies, oversees GLP/non-GLP toxicology studies, and guides risk assessment and regulatory interactions to inform portfolio decisions.

Based in Cambridge, MA with hybrid onsite work, the candidate will mentor scientists, collaborate with Early Development and R&D leaders, and maintain regulatory and industry knowledge to