Senior Medical Director, Clinical Research- Hepatology
Alnylam Pharmaceuticals
8 hours ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Key Responsibilities:
- Strategically lead clinical programs and provide a strong, clear clinical voice.
- Develop creative but realistic drug development approaches and lead clinical efforts to secure global regulatory approvals.
- Oversee trial conduct and safety.
- Provide strategic consultation and guidance to Research on decisions with significant clinical components/implications.
- Collaborate with Preclinical, Regulatory Affairs, Medical Affairs, and Commercial to ensure tight integration of product development plans.
- Own relevant timelines and deliverables via Clinical Research and Operations.
- Drive/supervise major written deliverables (regulatory submissions, original articles, abstracts) and presentation materials.
- Perform final review and sign-off on controlled documents (protocols, investigator brochures, informed consent forms) as appropriate under SOPs.
- Influence internal and external audiences in a highly visible manner.
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 desirable.
- 5+ years industry experience or equivalent clinical academic experience.
- Strong scientific and clinical judgment.
- Proven track record leading Phase 2/3 clinical programs with major interactions with Health Authorities.
- Familiarity with clinical research and trial design, including biostatistics, regulatory organizations, guidelines, and practices.
- Ability to present ideas and document complex medical/clinical concepts in written and oral communication.
- Demonstrated problem-solving with sound, balanced judgment.
- Outstanding leadership and collaboration in a matrix environment.
- Experience with biotech/pharma partners is a plus.
Benefits (as stated): Medical, dental, vision; life and disability insurance; lifestyle reimbursement; flexible spending/HSAs; 401(k) with generous match; paid time off, wellness days, holidays, two recharge breaks; family resources and leave.
Hybrid location: Cambridge, MA or Maidenhead, UK.
Comp/Incentives (as stated): Eligible for annual short-term incentive and annual long-term incentive (e.g., equity).
- Strategically lead clinical programs and provide a strong, clear clinical voice.
- Develop creative but realistic drug development approaches and lead clinical efforts to secure global regulatory approvals.
- Oversee trial conduct and safety.
- Provide strategic consultation and guidance to Research on decisions with significant clinical components/implications.
- Collaborate with Preclinical, Regulatory Affairs, Medical Affairs, and Commercial to ensure tight integration of product development plans.
- Own relevant timelines and deliverables via Clinical Research and Operations.
- Drive/supervise major written deliverables (regulatory submissions, original articles, abstracts) and presentation materials.
- Perform final review and sign-off on controlled documents (protocols, investigator brochures, informed consent forms) as appropriate under SOPs.
- Influence internal and external audiences in a highly visible manner.
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 desirable.
- 5+ years industry experience or equivalent clinical academic experience.
- Strong scientific and clinical judgment.
- Proven track record leading Phase 2/3 clinical programs with major interactions with Health Authorities.
- Familiarity with clinical research and trial design, including biostatistics, regulatory organizations, guidelines, and practices.
- Ability to present ideas and document complex medical/clinical concepts in written and oral communication.
- Demonstrated problem-solving with sound, balanced judgment.
- Outstanding leadership and collaboration in a matrix environment.
- Experience with biotech/pharma partners is a plus.
Benefits (as stated): Medical, dental, vision; life and disability insurance; lifestyle reimbursement; flexible spending/HSAs; 401(k) with generous match; paid time off, wellness days, holidays, two recharge breaks; family resources and leave.
Hybrid location: Cambridge, MA or Maidenhead, UK.
Comp/Incentives (as stated): Eligible for annual short-term incentive and annual long-term incentive (e.g., equity).