Senior Clinical Lead, Early Clinical & Experimental Therapeutics

Responsibilities:

• Design safe, rapid, informative First-In-Human studies (incl. natural history, experimental model validation, mechanistic/signal-seeking, streamlined PoM/PoC) to support early Go/No-Go decisions and PK studies.
• Integrate clinical development steps into overall development strategy; provide medical/clinical expertise to guide preclinical data generation and interpretation.
• Make front-line decisions on protocol design, execution, dose escalation, safety, and information for Regulatory authorities.
• Supervise clinical study execution; oversee and perform medical monitoring.
• Review/interpret results and author ECET-related clinical documentation (ICFs, protocols, study reports, clinical pharmacology/ECET components of investigator brochures, regulatory documents).
• Participate in dose selection and drive Go/No-Go; ensure follow-up and timelines; ensure GCP/clinical trial standards.
• Maintain collaborations; coordinate CRO/outsourced oversight; lead dose escalation meetings; review AE reports; coordinate cross-functional communication.
• Participate in data review/validation; prepare Key Results Memo and Clinical Study Report.

• Design and conduct FIH to phase2a studies; review/approve study documentation; coordinate team setup; ensure documentation to Ethics Committees/Health Authorities.

• Education:
  
  M.D. or M.D./Ph.D.
• Experience:
  
  3+ years clinical research incl. early (Phase1/2a) patient oversight and interpretation of preclinical/biomarker data; design/execution of phase1/2a and exploratory studies in pharma/academic/CRO settings; lead cross-functional teams; medical safety oversight; translational/biomarker research; use digital/AI tools.

• Biomedical knowledge to design/interpret nonclinical and clinical experiments; GCP knowledge; excellent verbal/written communication; risk-management mindset; matrix organization ability; international/intercultural working skills; challenge decisions.

• MD + PhD; global pharma experience; combination therapy and cytoplasmic signaling pathway drugs; residency/lab research; late-phase trial experience.

• High-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.