About this role
Lead and oversee a team of toxicologists and technical staff, fostering scientific excellence, collaboration, and professional development. Provide strategic leadership for nonclinical safety assessment programs supporting discovery, development, and regulatory submissions. Collaborate effectively across disciplines, including pathology, DMPK, biology, clinical, regulatory, and pharmacology, ensuring strong cross-functional integration. Engage effectively with regulatory authorities, supporting product defense and contributing to successful regulatory submissions and approvals. Design and implement scientifically robust and strategically aligned nonclinical development programs to support advancement of drug candidates and regulatory filings. Lead and manage nonclinical studies and programs across a portfolio of projects, conducted internally and through CRO partners, either directly or through direct reports. Prepare and critically review scientific and regulatory documents to ensure high quality, clarity of presentation, and sound scientific interpretation. Partner with cross-functional teams to design investigative toxicology studies supporting development candidates and platform technology evaluations. Present key findings and safety strategies to program teams, R&D leadership, and regulatory authorities. Mentor and develop toxicologists and scientists, helping build organizational expertise in pharmaceutical toxicology and nonclinical safety. PhD in Toxicology, Pathology, or a related scientific discipline. 15+ years of experience in the pharmaceutical or biotechnology industry, with demonstrated expertise and accomplishments in regulatory toxicology. Proven leadership experience managing departments, groups, or teams within a scientific organization. Demonstrated experience preparing and supporting global regulatory submissions and associated documentation. Strong ability to interpret and integrate complex datasets across multiple disciplines, including pharmacology, DMPK, toxicology, and pathology, with a focus on assessing clinical relevance and impact. Proven ability to apply creative and strategic approaches to resolving challenges in predictive toxicology. Strong problem-solving skills, with the ability to remain highly organized and lead effectively in a fast-paced environment with evolving priorities. Excellent interpersonal skills and a demonstrated ability to collaborate across diverse cross-functional teams. Excellent written and verbal communication skills. Strong interest in the therapeutic and scientific areas aligned with Alnylam's research focus.
About Alnylam Pharmaceuticals
Biopharmaceutical company pioneering RNA interference (RNAi) therapeutics for rare genetic, cardiometabolic, and CNS diseases. Headquartered in Cambridge, MA.
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