28 days old

Associate Director, Combination Products

Alnylam Pharmaceuticals
Cambridge, MA 02139
  • Job Code
    TOQA20191038

Associate Director, Combination Products

Overview

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.

The Associate Director, Combination Products is responsible for developing and maintaining Combination Products including Risk Management, Design Assurance, and Human Factors Engineering. This role collaborates with expertise areas outside of Drug Delivery including but not limited to Formulation, Manufacturing, Commercial, Clinical, Medical Affairs, Quality Assurance, Partners, Vendors, and Regulatory Affairs to commercialize and maintain patient-centric Combination Products. Will establish and manage timelines, resource loading, and risk mitigation plans. Program activities will include evaluation of patient needs, evaluation and selection of vendors and manufactures, and evaluation and management of costs.

Summary of Key Responsibilities

  • Act as a lead on CMC Programs for the development and lifecycle management
  • Lead Human Factors Engineering Activities for Alnylam Combination Products including Task Analysis, Harms, Hazards, Human Factors Engineering Plans, Instructions for Use Development, Expert Reviews, Formative Usability Study Protocol Development, Formative Usability Study Execution, Formative Usability Study Reports, Summative Usability Study Protocol Development, Summative Usability Study Execution, Summative Usability Study Reports, and Human Factors Summary Report. Develop Vendor network to facilitate Human Factors Engineering Activities
  • Oversee Risk Management for Alnylam's Drug Delivery Programs and Combination Products including Use, Design, and Process Risk Assessments across Vendors and CMOs, and Post-Launch Risk Management Surveillance
  • Ensure continuity of Risk Management Methodology and Application including Rankings and Risk Acceptability across Alnylam's Drug Delivery Portfolio
  • Serve as Subject Matter Expert for Design Assurance activities on Combination Product Programs and Lead Cross-functional Reviews and Updates to Alnylam's Combination Product SOPs as well as synchronization with Alnylam's overall QMS.
  • Participate in development of clinical and commercial regulatory submissions.
  • Develop Alnylam Templates and Guidance Documents to drive consistency and sufficiency of Design Control Documentation per FDA and ISO Regulations
  • Create an update Combination Product QMS documents as needed to maintain regulatory compliance
  • Drive timely decisions, and facilitate active communication and information flow between team members, Program Teams, and impacted sites/expertise areas
  • Schedule and run cross-functional team meetings to manage execution of project plan
  • Remains up-to-date with current regulations, industry guidance, and practices for consistent best practices across all Drug Delivery activities

Qualifications

  • Bachelor's degree, preferably in engineering or life sciences. Advanced degree preferred but not required. Experience: 15 years
  • SME in human factors engineering, design controls, documentation, specification development, testing, and risk management required
  • Experience in the assessment, development and/or manufacture of combination products required
  • Experience handling projects with external vendors and contract manufacturers required
  • Excellent documentation skills, e.g., reports, requirements, and specifications
  • Must have excellent interpersonal and customer service skills

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

#LI-CM1





Posted: 2019-06-19 Expires: 2019-07-18
Sponsored by:
Farm Credit Services of America Logo
Sponsored by:
Bank of America Logo

Featured Jobs[ View All ]

Featured Employers

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Associate Director, Combination Products

Alnylam Pharmaceuticals
Cambridge, MA 02139

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast