Clinical Program Leader; CPL

Key Responsibilities

• Provide strategic medical guidance for development of new oncology agents in preclinical development (typically from DC phase); accountable for Translational Clinical Oncology (TCO) aspects of global drug development programs.
• Establish/approve scientific methods for clinical protocol design, data collection systems, and final reports.
• Evaluate external business development opportunities.
• Create clinical development strategy for new oncology agents, supporting subsequent registration trials.
• Lead Biomedical Research Program Teams (BPTs) from GLP toxicology studies through clinical trials; may lead multiple global project teams.
• Support new and ongoing clinical research/trials; ensure efficient processing of confidentiality and clinical agreements.
• Develop the Integrated Development Plan (IDPA).
• Integrate preclinical information (pharmacology, toxicology, pharmacokinetics) and interpret implications for clinical development.
• Collaborate on clinical protocol and study instrument development (e.g., case report forms, report/analysis plans, clinical study reports).
• Ensure safe, ethical, efficient trial conduct; maintain compliance with GCP and SOPs.
• Liaise with experts, investigators, and regulatory authorities; act as medical monitor for global studies; write/review abstracts/manuscripts; participate in task forces; mentor less experienced CPLs.

• On-site role in Cambridge, MA (not remote); ~10% travel.
• Dual level: CPL (1–3 years) or Senior CPL (3–5+ years) leading complex early-phase oncology programs; experience interpreting oncology preclinical data (molecular biology, pharmacology, PK, toxicology).
• MD/DO plus additional lab-based training; board certification (or equivalent) in an oncology subspecialty.
• Knowledge of PK/PD and biostatistics in clinical development; ability to analyze oncology efficacy/safety data; GCP and worldwide regulatory requirements.
• Strong medical/scientific writing and oral presentation skills.
• Proven team leadership; multidisciplinary collaboration; creative/independent PoC study design and critical thinking.

• Pharma/biotech industry preferred;
  PhD.