Senior Medical Director, Clinical Research - Neurodegeneration
Alnylam Pharmaceuticals
14 days ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Key Responsibilities
- Be the strategic leader providing a strong, clear voice for clinical programs.
- Develop creative but realistic approaches to drug development; lead clinical efforts to secure global regulatory approvals.
- Oversight of trial conduct and safety.
- Provide strategic consultation and guidance to Research on decisions with significant clinical components.
- Collaborate with Preclinical, Regulatory Affairs, Medical Affairs, and Commercial to ensure tight strategic integration of product development plans.
- Be accountable for relevant timelines and deliverables via Clinical Research and Operations.
- Drive/supervise major written deliverables (regulatory submissions, original articles, abstracts) and presentation materials.
- Final review and sign off (as appropriate to SOPs) for controlled documents including protocols, IBs, and informed consent forms.
- Influence internal and external audiences in a high-impact, highly visible fashion.
Qualifications
- MD with strong research background or MD PhD; track record of successful research support and peer-reviewed publications.
- Board Certification (or equivalent) or specialist training highly desirable.
- 10+ years industry experience or equivalent clinical academic experience.
- Sound scientific and clinical judgment.
- Successful track record leading Phase 2/3 clinical programs (preferably Huntington’s), including major Health Authority interactions.
- Familiarity with clinical research/trial design, including biostatistics, regulatory organization, guidelines, and practices.
- Ability to present and document complex medical/clinical concepts (written and oral).
- Strong leadership and collaboration in a matrix environment; problem-solving judgment.
- Experience with biotech/pharma partners a plus.
Benefits
- Comprehensive benefits including medical, dental, and vision coverage; life and disability insurance; lifestyle reimbursement; flexible spending/HSAs; 401(k) with company match; paid time off, wellness days, holidays, and recharge breaks; family resources and leave.
- Be the strategic leader providing a strong, clear voice for clinical programs.
- Develop creative but realistic approaches to drug development; lead clinical efforts to secure global regulatory approvals.
- Oversight of trial conduct and safety.
- Provide strategic consultation and guidance to Research on decisions with significant clinical components.
- Collaborate with Preclinical, Regulatory Affairs, Medical Affairs, and Commercial to ensure tight strategic integration of product development plans.
- Be accountable for relevant timelines and deliverables via Clinical Research and Operations.
- Drive/supervise major written deliverables (regulatory submissions, original articles, abstracts) and presentation materials.
- Final review and sign off (as appropriate to SOPs) for controlled documents including protocols, IBs, and informed consent forms.
- Influence internal and external audiences in a high-impact, highly visible fashion.
Qualifications
- MD with strong research background or MD PhD; track record of successful research support and peer-reviewed publications.
- Board Certification (or equivalent) or specialist training highly desirable.
- 10+ years industry experience or equivalent clinical academic experience.
- Sound scientific and clinical judgment.
- Successful track record leading Phase 2/3 clinical programs (preferably Huntington’s), including major Health Authority interactions.
- Familiarity with clinical research/trial design, including biostatistics, regulatory organization, guidelines, and practices.
- Ability to present and document complex medical/clinical concepts (written and oral).
- Strong leadership and collaboration in a matrix environment; problem-solving judgment.
- Experience with biotech/pharma partners a plus.
Benefits
- Comprehensive benefits including medical, dental, and vision coverage; life and disability insurance; lifestyle reimbursement; flexible spending/HSAs; 401(k) with company match; paid time off, wellness days, holidays, and recharge breaks; family resources and leave.