Alnylam Pharmaceuticals
Director, Regulatory Filing Excellence and Project Management (Finance)
Alnylam is the industry leader in the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to address the unmet needs of patients with debilitating diseases. Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality, and is now advancing a robust pipeline of investigational RNAi therapeutic medicines, including five programs in late-stage development. In 2018, Alnylam received approval for our first product, the first-ever RNAi therapeutic, by the FDA in the U.S. for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults and by the European Medicines Agency in the EU for the treatment of hATTR amyloidosis in adults with stage 1 or stage 2 polyneuropathy. Headquartered in Cambridge, Mass., Alnylam employs over 1,200 people in 18 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 four years in a row (2015-2018) and a Great Place to Work in the U.K. and Switzerland in 2019. Please visit www.alnylam.com for more information.
Reporting to the Senior Director of Regulatory Technology & Operations, this role will manage cross-functional global filing teams for major regulatory filings throughout the product life cycle in close partnership with the Global Regulatory Affairs lead, Regulatory Operations lead, program team leadership and expertise area leaders. This is a senior project management role with a focus on developing regulatory filing excellence, management of regulatory filing project plans and risks, reporting progress to management and partners, as well as investment planning and resourcing in line with the overall strategic objectives and goals. Ideally this person will be experienced in all stages of drug development with involvement in successful IND, NDA/MAA submissions and commercialization.
Summary of Key Responsibilities
Qualifications
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.