Clinical Program Leader (CPL)
Novartis
June 27, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Responsibilities:
- Provide strategic medical and scientific leadership for development of preclinical oncology agents (e.g., small molecules, biologics, radioligand therapies), typically starting at PE/DC.
- Create clinical development strategies from PE/DC to TDP, integrating medical expertise with Clinical Pharmacology, Biostatistics, and other disciplines to optimize global/functional execution.
- Provide early clinical development planning to foresee and support subsequent registration trials; develop the Integrated Development Plan Approval (IDPA) aligned with CPL Disease Area Leads, Development, Strategy & Growth, and Commercial teams.
- Lead Biomedical Research Early Program Teams (BPTs) to enable clinical development and trials needed to support TDP; may lead multiple global project teams.
- Integrate and interpret preclinical data (pharmacology, toxicology, pharmacokinetics) for clinical development decisions.
- Collaborate with clinical scientists to develop clinical protocols and required study instruments (e.g., CRFs, reporting/analysis plans, clinical study reports).
- Ensure safe, ethical, and efficient conduct of trials; apply GCP and relevant SOPs to maintain compliance.
- Liaise with external experts, investigators, and regulatory authorities; represent projects.
- Write/review abstracts and manuscripts for presentations/publications.
- Participate in task forces; operational responsibility for quality and compliance; may mentor less experienced CPLs.
Qualifications:
- MD or DO.
- Board certification in an oncology specialty; PhD-level science preferred.
- Fluent English (oral and written).
- At least 2 years pharma/biotech oncology clinical trials experience plus equivalent academic medical center duration (or comparable senior academic translational oncology/clinical research experience).
- Expert recognition via external publications and international recognition (preferred).
- Strong oncology preclinical data interpretation; PK/PD and biostatistics knowledge.
- Proven ability to analyze efficacy/safety data; GCP and global regulatory knowledge.
- Excellent medical/scientific writing and English communication skills.
- Strategic thinking; ability to develop multidisciplinary global teams; strong ethics; strong office IT skills.
- Provide strategic medical and scientific leadership for development of preclinical oncology agents (e.g., small molecules, biologics, radioligand therapies), typically starting at PE/DC.
- Create clinical development strategies from PE/DC to TDP, integrating medical expertise with Clinical Pharmacology, Biostatistics, and other disciplines to optimize global/functional execution.
- Provide early clinical development planning to foresee and support subsequent registration trials; develop the Integrated Development Plan Approval (IDPA) aligned with CPL Disease Area Leads, Development, Strategy & Growth, and Commercial teams.
- Lead Biomedical Research Early Program Teams (BPTs) to enable clinical development and trials needed to support TDP; may lead multiple global project teams.
- Integrate and interpret preclinical data (pharmacology, toxicology, pharmacokinetics) for clinical development decisions.
- Collaborate with clinical scientists to develop clinical protocols and required study instruments (e.g., CRFs, reporting/analysis plans, clinical study reports).
- Ensure safe, ethical, and efficient conduct of trials; apply GCP and relevant SOPs to maintain compliance.
- Liaise with external experts, investigators, and regulatory authorities; represent projects.
- Write/review abstracts and manuscripts for presentations/publications.
- Participate in task forces; operational responsibility for quality and compliance; may mentor less experienced CPLs.
Qualifications:
- MD or DO.
- Board certification in an oncology specialty; PhD-level science preferred.
- Fluent English (oral and written).
- At least 2 years pharma/biotech oncology clinical trials experience plus equivalent academic medical center duration (or comparable senior academic translational oncology/clinical research experience).
- Expert recognition via external publications and international recognition (preferred).
- Strong oncology preclinical data interpretation; PK/PD and biostatistics knowledge.
- Proven ability to analyze efficacy/safety data; GCP and global regulatory knowledge.
- Excellent medical/scientific writing and English communication skills.
- Strategic thinking; ability to develop multidisciplinary global teams; strong ethics; strong office IT skills.