Responsibilities:
- Provide strategic clinical leadership and be the clear voice for clinical programs.
- Drive clinical development pipeline forward through leadership of clinical development programs (primary focus: Huntington’s program), across therapeutic areas and development stages.
- Develop creative but realistic drug development approaches; lead efforts to secure global regulatory approvals.
- Oversee trial conduct and patient safety.
- Advise Research on decisions with significant clinical implications; support feasibility of novel targets and proof-of-concept study design.
- Collaborate across Preclinical, Regulatory Affairs, Medical Affairs, and Commercial for integrated product development plans.
- Own clinical research/operations timelines and deliverables.
- Lead/supervise major written deliverables (regulatory submissions, articles, abstracts) and presentation materials.
- Perform final review/sign-off on controlled documents (protocols, investigator brochures, informed consent forms) per SOPs.
- Represent the organization at external/regulatory/scientific meetings.
Qualifications (Required/Preferred):
- MD with strong research background or MD PhD; peer-reviewed publications (Board Certification/specialist training desirable).
- 10+ years industry or equivalent clinical academic experience.
- Successful track record leading Phase 2/3 programs (preferably Huntington’s) with Health Authority interactions.
- Strong scientific/clinical judgment; knowledge of clinical research/trial design, biostatistics, and regulatory guidelines.
- Excellent written/oral communication; strong leadership and matrix collaboration.
- Drug development experience in neurology (Huntington’s) preferred; biotech/pharma partner experience a plus.
Benefits/Compensation (as stated):
- U.S. Pay Range: $305,700.00–$413,700.00; eligible for annual short-term incentive and annual long-term incentive.
- Medical/dental/vision, life/disability, lifestyle reimbursement, flexible spending/HSAs, 401(k) match, paid time off, wellness days, holidays, and recharge breaks; family resources and leave.
Location: Hybrid—Cambridge, MA (HQ) or Maidenhead, UK.