Principal Scientist, Toxicology

Overview:

We are seeking a highly motivated individual with drug development and regulatory toxicology experience to join our expanding Toxicology group within our Early Development (eDEV) functional area. Candidates should have doctoral level research training in toxicology or related discipline and preferably be board-certified in general toxicology (DABT). The candidate will develop the regulatory toxicology strategy for selected programs, design and supervise internal

and contract laboratory studies, review and finalize reports, and interpret and integrate all nonclinical findings, and then summarize into regulatory submissions. For early-stage programs, the successful candidate will assess target associated toxicities, identify the potential toxicity and define the therapeutic index of product development candidates. For development and

clinical-stage programs, he/she will lead all regulatory toxicology activities for assigned programs. An additional key role for this position will be to represent the Early Development functional area on assigned drug development program teams.

This position is onsite and will be primarily located in Cambridge, MA.  

Key Responsibilities

The successful candidate will have a key role in developing regulatory toxicology strategies and providing deep scientific interpretation of nonclinical findings as to their relevance and translation into clinical and regulatory development. The role will involve overseeing the conduct of non-GLP screening toxicity studies and managing externallyconducted GLP toxicology studies to support development of multiple drug candidates in Alnylam's industry-leading RNAi Therapeutics pipeline.

• Collaborate with Research to inform on in vivo study design and interpretation as part of lead candidate selection
• Collaborate with medicinal chemists and analytical scientists to ensure synthesis, formulation, and delivery of test articles for use in toxicology studies.
• Collaborate with DMPK and bioanalytical scientists to design and integrate DMPK results from studies on all assigned research and drug development programs.
• Use available published literature and other relevant sources to author target safety assessments for new therapeutic targets
• Represent Toxicology and Early Development on project teams, guiding development programs and project prioritization by responding quickly to data from ongoing studies and providing input to management and development teams.
• Prepare and review toxicology sections of regulatory documents, including preIND packages, INDs, clinical trial applications (CTAs), Investigator Brochures, special protocol reviews, regulatory Briefing Documents and NDAs/MAAs.
• Summarize experimental results for presentations both within and outside of the company, particularly representing the findings to regulatory authorities.

Qualifications:

• Ph.D. with postdoctoral experience in toxicology or a related field  with 5-7+ years relevant experience in the biotechnology/pharmaceutical industry.
• DABT preferred for the toxicologist.
• The candidate should have an understanding of the biology associated with RNAi and its application for therapeutic intervention across multiple disease indications
• Previous experience in managing nonclinical toxicology/safety programs, and design, execution, and regulatory reporting of GLP toxicology and safety pharmacology studies is required. Experience in drug development and regulatory submissions, including IND/CTA and NDA is desired.
• A proven track record of successful regulatory submissions will enhance candidate consideration.
• Individual needs to be open-minded, self-motivated, attentive to detail, capable of identifying and solving problems independently, and dedicated to quality and safety of therapeutics.
• Given that the successful candidate will have leadership responsibilities for representing drug safety evaluation on the relevant multi-functional program teams, he/she will have the ability to independently set and convey the toxicology and non-clinical strategy to colleagues across the R&D matrix.
• He/she should be an outstanding communicator and presenter in order to communicate our progress to key internal and external audiences.
• Consistent with the strong scientific basis for all aspects of our work, he/she should enjoy a fast-paced, data-driven environment working in a matrix with various colleagues from R&D to help establish the road map for the discovery and development of RNAi therapeutics.
  
  

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.