Alnylam Pharmaceuticals, one of Cambridge’s most innovative, publicly traded biotech companies, focused on translating the science of siRNA into human therapies, is looking for a scientist who will be involved in the design, execution, analysis, interpretation and communication of pharmacokinetics (PK) and absorption, distribution, metabolism, and excretion (ADME) studies of siRNA and their associated delivery system to support drug development from preclinical through clinical development. The individual will serve as DMPK project representative to coordinate and lead all nonclinical DMPK activities on programs from the research phase through development. As such, an individual with in-depth knowledge and expertise in PK and ADME would be essential. The individual will also provide translational modeling & simulation support to further optimize the efficacy and safety of our platform and discovery pipeline. The role will suit a highly motivated individual who has a passion for science, enjoys developing new, highly innovative technologies, exhibits urgency and has a good cultural fit with a growing and energized small-medium size biotech environment.
Summary of Key Responsibilities
Design and execute preclinical studies to understand the pharmacokinetics (PK) and absorption, metabolism, distribution, and excretion (ADME) of drug candidates
Represent DMPK as the subject matter expert to Alnylam project teams
Responsible for the analysis, interpretation, integration and reporting of preclinical DMPK data generated both internally and with external vendors/academic sites
Build and develop quantitative tools to translate PK/PD relationship from preclinical to clinical using modeling and simulation for siRNAs
Participate in the management of CROs/academic sites in the conduct of in vitro/in vivo ADME studies
Prepare strategic and scientifically sophisticated ADME strategies that meet regulatory requirements and program goals
Author high quality Regulatory documents including INDs, CTAs and NDA filings. Partner with and support Toxicology, Research, Clinical, Regulatory, Project Management and other departments
Participate in the preparation of abstracts and manuscripts for publication
D. in Pharmacokinetics, Pharmacology, Pharmaceutics or other relevant field with 0 to 5 years of experience in the biopharmaceutical industry, with evidence of drug development experience is essential
Strong knowledge of drug metabolism, ADME concepts, pharmacokinetics, pharmacodynamic and bioanalytical principles is required. Experience in metabolism aspect of oligonucleotides (e.g., ASO, siRNA, etc.) is highly desirable
Proficient in using WinNonlin or other pharmacokinetic software
Working knowledge in various modeling techniques and programing is a plus
Strong communication (verbal and written) and presentation skills required
Excellent interpersonal skills and ability to represent DMPK in a team environment are essential
Prior experience with regulatory submission (e.g., IND, BLA and/or NDA) is a plus
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.
Internal Number: RD2020R1011
Alnylam is the world’s leading RNA interference (RNAi) company.
Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality by harnessing the power of RNAi for human health as an innovative new class of medicines. We are a growing biopharmaceutical company with two approved medicines and a robust pipeline of investigational medicines focused in four strategic therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases, including several in late-stage development.
Headquartered in Cambridge, Mass., Alnylam employs over 1,400 people in 19 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe’s Top Places to Work five years in a row (2015-2019), a Great Place to Work in the U.K. and Switzerland in 2020 and Science Magazine’s #1 Top Employer in 2019. Please visit www.alnylam.com for more information.