Clinical Program Lead (CPL) - RLT Focus
Novartis
September 02, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Responsibilities:
- Provide strategic medical/scientific leadership for development of new oncology agents (small molecules, biologics, radioligand therapies) in preclinical development, typically from PE/DC through TDP.
- Create and optimize clinical development strategies across PE/DC to TDP with cross-functional disciplines (e.g., Clinical Pharmacology, Biostatistics).
- Provide early clinical strategy that anticipates and supports subsequent registration trials; develop the Integrated Development Plan Approval (IDPA) with Disease Area Leads, Development, Strategy & Growth, and Commercial.
- Lead Biomedical Research Early Program Teams (BPTs) to enable clinical development and required trials for TDP (may lead multiple global teams).
- Integrate preclinical findings (pharmacology, toxicology, PK) and interpret implications for clinical development (Investigator’s Brochure, First-in-Human protocol).
- Collaborate to develop clinical protocols and instruments (CRFs, analysis/report plans, clinical study reports).
- Guide safe, ethical, efficient trial conduct; ensure compliance with GCP and SOPs.
- Liaise with external experts, investigators, and regulators; represent projects.
- Write/review abstracts and manuscripts; participate in task forces; operational responsibility for quality/compliance.
- May mentor less experienced CPLs.
Qualifications:
- MD or DO.
- Board certification in an oncology specialty; PhD-level science preferred.
- Fluent English (oral/written).
- 2+ years pharma/biotech oncology clinical trial experience plus equivalent academic duration; or comparable senior academic experience in translational oncology/clinical research.
- Preferred: RLT experience; recognized external expert with publication record.
- Strong oncology preclinical data interpretation (molecular biology, pharmacology, PK, toxicology).
- Strong PK/PD, biostatistics, efficacy/safety interpretation, GCP, and worldwide regulatory knowledge.
- Excellent medical/scientific writing; strategic thinking; ability to lead global multidisciplinary teams.
- Ethical integrity; strong English communication/presentation; strong office IT skills.
Compensation/Benefits:
- Salary expected: $248,500–$461,500 (annual).
- Performance-based cash incentive; possible annual equity awards (role-dependent).
- Comprehensive benefits (US-based eligible): health/life/disability, 401(k) with match, and time off (vacation, personal days, holidays, and other leaves).
- Provide strategic medical/scientific leadership for development of new oncology agents (small molecules, biologics, radioligand therapies) in preclinical development, typically from PE/DC through TDP.
- Create and optimize clinical development strategies across PE/DC to TDP with cross-functional disciplines (e.g., Clinical Pharmacology, Biostatistics).
- Provide early clinical strategy that anticipates and supports subsequent registration trials; develop the Integrated Development Plan Approval (IDPA) with Disease Area Leads, Development, Strategy & Growth, and Commercial.
- Lead Biomedical Research Early Program Teams (BPTs) to enable clinical development and required trials for TDP (may lead multiple global teams).
- Integrate preclinical findings (pharmacology, toxicology, PK) and interpret implications for clinical development (Investigator’s Brochure, First-in-Human protocol).
- Collaborate to develop clinical protocols and instruments (CRFs, analysis/report plans, clinical study reports).
- Guide safe, ethical, efficient trial conduct; ensure compliance with GCP and SOPs.
- Liaise with external experts, investigators, and regulators; represent projects.
- Write/review abstracts and manuscripts; participate in task forces; operational responsibility for quality/compliance.
- May mentor less experienced CPLs.
Qualifications:
- MD or DO.
- Board certification in an oncology specialty; PhD-level science preferred.
- Fluent English (oral/written).
- 2+ years pharma/biotech oncology clinical trial experience plus equivalent academic duration; or comparable senior academic experience in translational oncology/clinical research.
- Preferred: RLT experience; recognized external expert with publication record.
- Strong oncology preclinical data interpretation (molecular biology, pharmacology, PK, toxicology).
- Strong PK/PD, biostatistics, efficacy/safety interpretation, GCP, and worldwide regulatory knowledge.
- Excellent medical/scientific writing; strategic thinking; ability to lead global multidisciplinary teams.
- Ethical integrity; strong English communication/presentation; strong office IT skills.
Compensation/Benefits:
- Salary expected: $248,500–$461,500 (annual).
- Performance-based cash incentive; possible annual equity awards (role-dependent).
- Comprehensive benefits (US-based eligible): health/life/disability, 401(k) with match, and time off (vacation, personal days, holidays, and other leaves).