Clinical Program Leader (CPL)
Novartis
18 days ago
On-site
Cambridge, MA
Clinical Research and Development
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.
Essential Requirements:
- 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.
Desirable Requirements:
- Pharma/biotech industry preferred; PhD.
- 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.
Essential Requirements:
- 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.
Desirable Requirements:
- Pharma/biotech industry preferred; PhD.