Overview
Alnylam Pharmaceuticals is seeking an imaginative physician drug developer. This is an opportunity to provide clinical leadership in developing RNAi therapeutics in Alnylam’s rapidly expanding portfolio, which spans the areas of rare genetic diseases, cardio-metabolic diseases, neuroscience, hematology and hepatology.
The successful candidate’s primary role will be to drive the pipeline forward through leadership of clinical development programs. While the primary focus responsibility will be as clinical lead physician on Alnylam’s Huntington’s program, the role may support across a range of therapeutic areas and all stages of development may be required as pipeline assets evolve. The Executive Director is expected to play a leading and influencing role in the overall clinical development strategies and drive progress and operational excellence for associated clinical trials. In addition, this role will include interaction with Alnylam’s research group, helping to advise the team on the clinical development feasibility of novel targets and the design of proof-of-concept studies. This work will also involve extensive consultation and collaboration with external experts. It is expected that additional opportunities will arise to lead bench-to-bedside early phase clinical development programs.
The Executive Director, Clinical Research, will work in a matrix organization across Regulatory, Biostatistics, Clinical Operations, Preclinical, Commercial & QA teams to ensure fully harmonized and integrated development strategies. They will be a key Alnylam Development spokesperson at external meetings, including regulatory interactions and scientific meetings.
This position is hybrid, requiring weekly onsite presence and will be primarily located at our Cambridge, MA headquarters or Maidenhead, UK location. Relocation may be possible for the selected candidate.
Key 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
Qualifications
- 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.
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