Clinical Program Lead (CPL) - RLT Focus
Novartis
5 hours ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Location: Cambridge, MA (Hybrid)
Major Accountabilities:
- Provide strategic medical and scientific leadership for development of new oncology agents in preclinical development (small molecules, biologics, radioligand therapies), typically beginning at PE/DC.
- Create clinical development strategies from PE/DC to TDP, partnering across disciplines (e.g., Clinical Pharmacology, Biostatistics) and delivering independent TCO strategy solutions globally.
- Provide early clinical development strategy that foresees and supports subsequent registration trials; develop the Integrated Development Plan Approval (IDPA) aligned with CPL Disease Area Leads (DALs), Development, Strategy & Growth, and Commercial.
- Lead Biomedical Research Early Program Teams (BPTs) to enable start of clinical development and through clinical trials needed for TDP (may lead multiple global project teams).
- Integrate preclinical pharmacology, toxicology, and pharmacokinetics findings to guide clinical development (e.g., Investigator’s Brochure, First-in-Human).
- Collaborate to develop clinical protocols and related instruments (e.g., case report forms, report/analysis plans, clinical study reports).
- Guide safe, ethical, efficient trial conduct; comply with GCP and Novartis SOPs.
- Liaise with outside experts, investigators, and regulatory authorities; represent projects.
- Write/review abstracts and manuscripts for internal/external presentations/publications.
- Participate in task forces; operational responsibility for quality and compliance.
- May provide informal mentorship to less experienced CPLs.
Qualifications:
- MD or DO. Board-certification in oncology specialty and PhD-level science preferred.
- Fluent English (oral and written).
- At least 2 years oncology clinical trials industry experience plus equivalent academic medical center duration; if limited industry experience, comparable senior academic translational oncology/clinical research experience.
- Experience within RLT preferred.
- Expert recognized by external medical experts; strong publication and international recognition.
- Excellent interpretation of oncology preclinical data (molecular biology, pharmacology, PK, toxicology).
- Strong PK/PD and biostatistics knowledge; ability to analyze efficacy and safety oncology data.
- Knowledge of GCP and worldwide regulatory requirements.
- Excellent medical/scientific writing; strategic thinking.
- Ability to lead multidisciplinary teams in a global environment.
- High ethical integrity and commitment to improving outcomes for patients with malignancies.
- Strong English communication/presentation skills; strong office IT skills.
Compensation/Benefits:
- Salary expected: $248,500–$461,500 (final based on skills/experience; reviewed periodically). Performance cash incentive; potential eligibility for annual equity awards. Comprehensive benefits and paid time off for US-based eligible employees.
Application instructions: Not specified.
Major Accountabilities:
- Provide strategic medical and scientific leadership for development of new oncology agents in preclinical development (small molecules, biologics, radioligand therapies), typically beginning at PE/DC.
- Create clinical development strategies from PE/DC to TDP, partnering across disciplines (e.g., Clinical Pharmacology, Biostatistics) and delivering independent TCO strategy solutions globally.
- Provide early clinical development strategy that foresees and supports subsequent registration trials; develop the Integrated Development Plan Approval (IDPA) aligned with CPL Disease Area Leads (DALs), Development, Strategy & Growth, and Commercial.
- Lead Biomedical Research Early Program Teams (BPTs) to enable start of clinical development and through clinical trials needed for TDP (may lead multiple global project teams).
- Integrate preclinical pharmacology, toxicology, and pharmacokinetics findings to guide clinical development (e.g., Investigator’s Brochure, First-in-Human).
- Collaborate to develop clinical protocols and related instruments (e.g., case report forms, report/analysis plans, clinical study reports).
- Guide safe, ethical, efficient trial conduct; comply with GCP and Novartis SOPs.
- Liaise with outside experts, investigators, and regulatory authorities; represent projects.
- Write/review abstracts and manuscripts for internal/external presentations/publications.
- Participate in task forces; operational responsibility for quality and compliance.
- May provide informal mentorship to less experienced CPLs.
Qualifications:
- MD or DO. Board-certification in oncology specialty and PhD-level science preferred.
- Fluent English (oral and written).
- At least 2 years oncology clinical trials industry experience plus equivalent academic medical center duration; if limited industry experience, comparable senior academic translational oncology/clinical research experience.
- Experience within RLT preferred.
- Expert recognized by external medical experts; strong publication and international recognition.
- Excellent interpretation of oncology preclinical data (molecular biology, pharmacology, PK, toxicology).
- Strong PK/PD and biostatistics knowledge; ability to analyze efficacy and safety oncology data.
- Knowledge of GCP and worldwide regulatory requirements.
- Excellent medical/scientific writing; strategic thinking.
- Ability to lead multidisciplinary teams in a global environment.
- High ethical integrity and commitment to improving outcomes for patients with malignancies.
- Strong English communication/presentation skills; strong office IT skills.
Compensation/Benefits:
- Salary expected: $248,500–$461,500 (final based on skills/experience; reviewed periodically). Performance cash incentive; potential eligibility for annual equity awards. Comprehensive benefits and paid time off for US-based eligible employees.
Application instructions: Not specified.