Alnylam Pharmaceuticals Inc logo

Senior Medical Director Clinical Research - Neurodegeneration

Alnylam Pharmaceuticals Inc
  • MA
    30+ days ago

    Job Description

    Be the strategic leader providing a strong, clear voice for the clinical programs Develop creative but realistic approaches to drug development and lead clinical efforts to secure global regulatory approvals Oversight of trial conduct and safety Provide strategic consultation and guidance to Research on all decisions that have significant clinical components and implications. Collaborate closely with Preclinical, Regulatory Affairs, Medical Affairs and Commercial to ensure tight strategic integration of product development plans Be accountable via Clinical Research and Operations for all relevant timelines and deliverables Drive/supervise all major written deliverables (regulatory submissions, original articles, abstracts), and presentation materials Be responsible (as appropriate in line with SOPs) for final review and sign off with respect to all controlled documents including protocols, IBs, informed consent forms Influence internal and external audiences in a high impact, highly visible fashion MD with strong research background or MD PhD, with a track record of successful research support and peer review publications. Board Certification (or equivalent) or specialist training is highly desirable; drug development experience in neurology (Huntington's Disease) would be a great advantage, but not essential 10+ years industry experience or equivalent clinical academic experience Sound scientific and clinical judgment Successful track record of leading Phase 2/3 clinical programs (preferably in Huntington's drug development), including major interactions with Health Authorities Familiarity with concepts of clinical research and clinical trial design, including biostatistics, regulatory agency organization, guidelines, and practices Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues Outstanding leadership and collaboration skills working within a matrix environment. Experience and knowledge of working with biotech/pharma partner(s) a plus Thrives in highly entrepreneurial biotech environment and embraces Alnylam's culture of science, passion and urgency.

    Numbers & Facts

    LocationMA
    IndustryHealthcare Services
    Year Founded2002
    Websitehttp://www.alnylam.com/

    About Company

    Alnylam is leading the translation of RNAi as a new class of innovative medicines, with a core focus on RNAi therapeutics toward genetically defined targets for the treatment of serious, life-threatening diseases with limited treatment options for patients and their caregivers.

    Skills

    • Biostatisticsunmatched
    • Biotech and Pharmaceuticalunmatched
    • Clinical Researchunmatched
    • Clinical Trialunmatched
    • Diseaseunmatched
    • Document Managementunmatched
    • Drug Developmentunmatched
    • Entrepreneurshipunmatched
    • Informed Consentunmatched
    • Leadershipunmatched
    • Medical Affairsunmatched
    • Medical Researchunmatched
    • Neurologyunmatched
    • Operations Researchunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Product Developmentunmatched
    • Publicationsunmatched
    • Regulationsunmatched
    • Regulatory Submissionsunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Team Playerunmatched

    Be found by employers

    5,500+ employers search our resume database daily. Add yours to get found by recruiters looking for candidates like you.

    Level up your application

    Professional resume templates

    Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.

    Free resume templates

    Free resume builder

    Improve your existing resume or start from scratch and create a standout, ATS-friendly resume. Add job-specific content, download and apply.

    Free resume builder