Senior Medical Director, Clinical Research - Neurodegeneration

Alnylam Pharmaceuticals•Cambridge, MA

2d•Hybrid

About The Position

Alnylam Pharmaceuticals is seeking an imaginative physician drug developer to provide clinical leadership in developing RNAi therapeutics. This role will drive the pipeline forward through leadership of clinical development programs, with a primary focus on Alnylam’s Huntington’s program. The position may also support across a range of therapeutic areas and all stages of development as pipeline assets evolve. The successful candidate will play a leading and influencing role in overall clinical development strategies, driving progress and operational excellence for associated clinical trials. This role includes interaction with Alnylam’s research group, advising on clinical development feasibility of novel targets and designing proof-of-concept studies, as well as extensive consultation with external experts. Opportunities to lead early-phase clinical development programs are also expected. The Senior Director, Clinical Research, will work in a matrix organization across Regulatory, Biostatistics, Clinical Operations, Preclinical, Commercial & QA teams to ensure harmonized and integrated development strategies. This individual will be a key Alnylam Development spokesperson at external meetings, including regulatory and scientific meetings. This position is hybrid and will be primarily located at our Cambridge, MA headquarters or Maidenhead, UK location.

Requirements

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
10+ years industry experience or equivalent clinical academic experience
Sound scientific and clinical judgment
Successful track record of leading Phase 2/3 clinical programs, 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.
Thrives in highly entrepreneurial biotech environment and embraces Alnylam’s culture of science, passion and urgency.

Nice To Haves

drug development experience in neurology (Huntington’s Disease) would be a great advantage, but not essential
Experience and knowledge of working with biotech/pharma partner(s) a plus

Responsibilities

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