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Director, Clinical Science

Company: Alnylam
Location: Cambridge
Posted on: January 8, 2021

Job Description:

Director, Clinical ScienceOverviewAlnylam 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.The successful candidate will be a member of the clinical development team, working closely with other members of the medical research group in clinical development (medical monitor, statistician, and clinical pharmacologist, translational research) to support investigations that deliver the development strategies for more than one drug. The successful Director, Clinical Science contributes to the trial development strategy assisting with protocol development and study design and clinical study execution. In addition, the Director, Clinical Science will contribute to clinical filing activities that are part of new drug applications, which can include activities such as preparing/editing regulatory documents and participating in responses to questions from Regulatory Agencies. The position will report to the Vice President, Clinical Research.Summary of Key ResponsibilitiesThe Director, Clinical Science will be familiar with drug development, drug mechanism of action, and regulatory requirements and will deploy this expertise in the execution of a number of key responsibilities:

  • Working with the Vice President as well as Medical Director(s), to create key strategic documents including clinical development plans, protocol concepts and full protocols for product(s) in early development along with contributing to activities for product(s) in later stages of development, including NDA filings.
  • Contribute to the development of clinical sections of regulatory documents such as Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions, and contribute to Clinical Development Plans
  • Performing medical data review during study execution to ensure integrity of accruing study data and appropriate safety follow-up.
  • Set up and management of investigator initiated clinical and/or pre-clinical trials
  • Develop effective working relationship with key investigators in assigned programs to optimize scientific quality/innovation of clinical study design, execution, reporting and publication.
    • Contribute to trial-related advisory boards.
    • Lead investigators meetings and protocol training meetings.
    • The Clinical Scientist is responsible for analyzing and interpreting study data from an individual study and translating study level clinical data across the program of studies for a particular drug, ensuring that all studies are conducted with the highest level of ethical and safety standards and are in compliance with GCP and all regulatory policies.
    • Prepare and run dose escalation meetings with investigators (phase 1).
    • Coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic and biomarker data, to provide consolidated information for dose escalation meetings and Phase II data reviews with investigators.
    • Assist in forecasting trial resource needs.
    • Assist in developing clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties.Qualifications
      • Master's Degree, PhD, PharmD, or M.D. with clinical trial/drug development Phase 1-3 expertise highly desirable
      • The ideal candidate will have 5+ years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company and/or contract research organization
        • The skills required for success in the job include scientific and analytic ability, ability to think strategically and tactically, an interest in applied clinical research, ability to work effectively in multifunctional and multinational teams, as well as the ability to multitask and prioritize
        • Proven experience in developing effective relationships with key investigatorsAlnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.LI#JR1

Keywords: Alnylam, Cambridge , Director, Clinical Science, Healthcare , Cambridge, Massachusetts

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