Senior Director, Toxicology

Alnylam Pharmaceuticals; United States; Hybrid; USD 230.000 - 320.000; Vollzeit

Zusammenfassung

Alnylam Pharmaceuticals is seeking a Senior Director, Toxicology to provide strategic scientific leadership for nonclinical safety across multiple R&D programs. The role leads the development of integrated nonclinical safety strategies and oversees GLP and non-GLP toxicology studies at CROs.

The position requires PhD in Toxicology or related field with 12+ years in pharma/biotech nonclinical development, and offers hybrid onsite work in Cambridge, MA.

Qualifikationen

• PhD in Toxicology or related field; board certification ideal.
• 12+ years in pharmaceutical/biotechnology industry supporting nonclinical drug development from discovery through registration.
• 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.
• Extensive knowledge of global regulatory guidance and standards (FDA GLP, OECD, ICH).
• Experience selecting and overseeing contract research organizations.
• Ability to integrate data across toxicology, pathology, DMPK, safety pharmacology, and related disciplines.
• Excellent written, verbal, and presentation skills; ability to communicate complex scientific topics clearly.
• Demonstrated ability to mentor and develop scientists.

Aufgaben

• Lead integrated, phase-appropriate nonclinical safety strategies across multiple development programs or platforms.
• Serve as senior Toxicology representative on cross-functional teams, guiding development from discovery through registration.
• Provide scientific leadership for nonclinical safety assessment and interpretation of studies; communicate risks and clinical relevance.
• Guide the design, conduct, interpretation, and reporting of GLP and non-GLP toxicology studies at contract research organizations.
• Maintain knowledge of industry trends and regulatory requirements to support regulatory submissions (INDs, CTAs, NDAs, BLAs, MAAs).
• Represent Toxicology in interactions with global health authorities as appropriate.

Kenntnisse

Leadership

Regulatory knowledge

Scientific judgment

Ausbildung

PhD in Toxicology

Jobbeschreibung

The Senior Director, Toxicology provides strategic scientific leadership for nonclinical safety across multiple research and development programs. As a subject matter expert, this individual leads the development and execution of integrated nonclinical safety strategies, working independently and, where applicable, through direct reports.

This role shapes nonclinical development strategy within or across therapeutic areas and provides scientific oversight for the design, conduct, interpretation, and reporting of GLP and non-GLP toxicology studies conducted at contract research organizations. The Senior Director partners with cross-functional teams and senior leaders to evaluate complex scientific and regulatory issues and inform program and portfolio decisions from discovery through registration.

The successful candidate will bring scientific rigor, sound judgment, and a collaborative approach to advancing the quality and safety of investigational therapeutics.

Hybrid onsite and will be primarily located in Cambridge, MA. Relocation may be considered for the right candidate.

Key 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.
• Serve as a recognized scientific resource within Toxicology and across R&D, guiding 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.

Required Qualifications

• PhD in Toxicology or an advanced degree in a related scientific discipline. Board certification ideal.
• Twelve (12) or more ears 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.

Preferred Qualifications

• Experience representing Toxicology in global health-authority interactions.
• Broad experience across multiple therapeutic areas, development programs, or technology platforms.

About Alnylam

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.

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.