Associate Director, Pharmacometrics

Associate Director, Pharmacometrics

Overview

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 three 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 1,500 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 six years in a row (2015-2020), a Great Place to Work in the U.K. and Switzerland two years in a row (2019-2020) and a Science Magazine’s Top Employer two years in a row (2019-2020). Please visit www.alnylam.com for more information.

Reporting to the Head of Pharmacometrics, the Associate Director of Pharmacometrics will champion quantitative pharmacokinetic and pharmacodynamics modeling and simulation strategy for clinical programs.  The Associate Director will be expected to drive the impact of quantitative PK/PD modeling and simulation to inform dose selection, dose optimization and dosing schedule for clinical studies and evaluate disease progression.

Summary of Key Responsibilities

• • With minimal supervision, strategize and formulate modeling and simulation strategy for assigned pre-clinical and clinical projects.        
  • Effectively collaborates with clinical pharmacology, Data Sciences and clinical development groups in developing analysis plans and contributes per timelines.
  • Champion modeling based drug development through their work across the organization. 
  • Independently analyzes, interprets, and reports PK/PD modeling results for internal decision making and regulatory filings. 
  • With minimal supervision, formulates responses to regulatory health authority inquiries on PK, PK/PD related issues.
  • Leads PK/PD strategy for novel siRNA modalities and disease modeling platforms.
  • Be a technical leader within the pharmacometrics group and mentor team members.
  • Maintains pharmacometrics role and visibility internally and externally through publications in peer reviewed journals and presentations at scientific meetings
  • Mentor junior pharmacometric scientists in the group

Qualifications

• • Candidates with a Ph.D (or equivalent) degree in pharmacokinetics, biopharmaceutics or related field     
  • At least 5 of pharmacometrics experience in pharmaceutical industry, consulting, or regulatory agency. Must have at least 3 years’ experience in pharmaceutical industry. Experience with regulatory interactions (e.g., responding and resolution to regulatory queries) including filing.
  • Be an expert in NONMEM and R. Must have strong understanding of population modeling methods, clinical endpoint modeling, disease progression modeling, and physiological & mechanistic modeling.

Superior Skills/Abilities:

• • Passionate about science and driven by scientific curiosity
  • Open minded, receptive to input and a strong team player
  • Self-driven, able to multi-task and manage time-sensitive workloads
  • Problem solver with ability to transform complex tasks into actionable deliverables
  • Strong interpersonal skills with ability to work in matrix environment
  • Strong written and oral presentation skills

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.