Senior Medical Director Clinical Research - Neurodegeneration

Alnylam Pharmaceuticals Inc

MA

JOB DETAILS
SKILLS
Biostatistics, Biotech and Pharmaceutical, Clinical Research, Clinical Trial, Disease, Document Management, Drug Development, Entrepreneurship, Informed Consent, Leadership, Medical Affairs, Medical Research, Neurology, Operations Research, Presentation/Verbal Skills, Problem Solving Skills, Product Development, Publications, Regulations, Regulatory Submissions, Standard Operating Procedures (SOP), Team Player
LOCATION
MA
POSTED
30+ days ago

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.

About the Company

A

Alnylam Pharmaceuticals Inc

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.
INDUSTRY
Healthcare Services
FOUNDED
2002
WEBSITE
http://www.alnylam.com/