Manager, Clinical Operations

Company: Alnylam
Location: Cambridge
Posted on: May 27, 2023

Job Description:

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. Alnylam currently has two commercial RNAi therapeutic products. The first product is approved in the U.S., EU, Canada, Japan, and Switzerland for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults and the second product is approved in the U.S. for the treatment of adults with acute hepatic porphyria (AHP). Alnylam also has a deep pipeline of investigational medicines, including five product candidates that are in late-stage development. Headquartered in Cambridge, Mass., Alnylam employs over 1,300 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 five years in a row (2015-2019), a Great Place to Work in the U.K. and Switzerland in 2019 and Science Magazine's #1 Top Employer in 2019. Please visit www.alnylam.com for more information.
Responsible for aspects of clinical development planning and strategy, clinical study planning and execution within pre-specified clinical development program, timelines and budget and includes, but is not limited to, preparation of study related materials, relationship management between study sites and vendors (in particular CROs), supervision of study related activities, identification of project risks and contingency planning.
Summary of Key Responsibilities

• Lead and manage integration of all project team activities, leveraging internal and development partner resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge.
• Provide strategic input and execution of clinical trials from protocol design to the final clinical study report for specified studies
• Provide leadership and input into global subject/patient recruitment plans.
• Effectively communicate and interact with Key Opinion Leaders.
• Manage all aspects of CRO/vendor identification, request for proposal submission, CRO selection, and the day to day operational management activities of CROs, development of Key performance Indicators (KPIs), management of global resources, expertise, and knowledge within the CRO/vendor.
• Manage strategic study operations including: study sites and tracking systems for regulatory submissions, CRO KPIs, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, Pharmacovigilance/Serious Adverse Events, performance metrics, data flow, etc.
• Participate in Case Report Form design, user acceptance testing in partnership with data management
• Generate country specific Informed Consent Form(s).
• Lead the development of contingency/risk management plans for projects and assist Director/Senior Director of Clinical Operations in the preparation and execution of sound development strategies.
• Provide support to clinical trial managers within and/or across programs.
• Budgets, timelines, and forecasts preparation for clinical studies.
• Interface with Finance, Program Management, Accounting, Supply Operations, Quality Assurance, Clinical Research, Commercial, Regulatory, Medical Affairs; which may include lading sub-teams and/or acting as a liaison between groups.
• Provide a variance analysis of budget to actual and notifies finance of projected cost over/under expenditure.
• Ability to travel (no more than annual average of 20%). Qualifications
  • Bachelor's Degree is required. An advanced degree in a scientific and/or business/finance discipline is preferred.
  • 6+ years of clinical research experience gained with a CRO or Pharmaceutical Company working on later stage (Phase 2-4) multinational clinical studies. Experience in rare diseases and/or difficult to recruit patient populations preferred.
  • 2-4+ years clinical project management experience with global clinical studies.
  • Strong regulatory knowledge, including Good Clinical Practices (GCPs)
  • Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.
  • Excellent communication (written and verbal) and presentation skills along with leadership qualities.
  • Knowledge of global clinical trial management in fast paced CRO outsourced environment. Ability to assemble a plan and execute on the details.
  • Apply project management best practices to programs. Experience in novel clinical drug development.
  • Experience with protocol, ICF, CRF, CSR development and review.
  • Strong organizational skills and ability to deal with competing priorities.
  • Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.
    Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

Keywords: Alnylam, Cambridge , Manager, Clinical Operations, Healthcare , Cambridge, Massachusetts