Clinical Program Leader

Novartis seeks a Senior Clinical Program Leader in Basel, CH, to lead the development of experimental oncology agents from preclinical stages through to TDP, providing strategic medical guidance and overseeing clinical trial execution.

This role offers strategic medical leadership for the development of new oncology agents within the TCO portfolio, guiding projects from preclinical evaluation (PE/DC) through to the TDP milestone, ensuring alignment across development, strategy, and commercial teams.

Responsibilities

• Delivers strategic medical and scientific leadership to project teams for oncology agents in preclinical development, starting at PE/DC stage.
• Designs clinical development strategies for new oncology compounds within the PE/DC to TDP timeline, integrating medical insights with cross-functional expertise.
• Prepares the Integrated Development Plan Approval (IDPA) in coordination with CPL Disease Area Leads, Development, Strategy & Growth, and Commercial teams.
• Leads Biomedical Research Early Program Teams (BPTs) to initiate and manage clinical development, potentially overseeing multiple global project teams.
• Interprets preclinical data (pharmacology, toxicology, pharmacokinetics) and integrates findings into clinical development plans, as reflected in the Investigator’s Brochure and First-in-Human protocol.
• Works with clinical scientists to design clinical protocols for TCO compounds and develop necessary tools for implementation, analysis, and reporting (e.g., case report forms, analysis plans, clinical study reports).
• Applies medical expertise to ensure safe, ethical, and efficient trial conduct, adhering to Good Clinical Practice (GCP) and Novartis Standard Operating Procedures.
• Engages with external experts, investigators, and regulatory bodies in oncology, representing projects to these stakeholders.
• Drafts and reviews abstracts and manuscripts for internal and external presentations or publications.
• Participates in task forces focused on continuous improvement and management goals, with operational responsibility for quality and compliance.
• May offer informal mentorship to less experienced Clinical Program Leaders.

Requirements

• MD or DO degree required.
• Minimum of 5 years of experience in oncology clinical trials within the pharmaceutical or biotech industry, or equivalent experience from an academic medical center.
• Recognized as an expert in oncology by external medical professionals and regulatory authorities; external candidates should have a strong publication record and international reputation.
• Strong ability to interpret oncology preclinical data, including molecular biology, pharmacology, pharmacokinetics, and toxicology.
• Solid understanding of PK/PD and biostatistics applications in clinical development and trials.
• Proven experience in analyzing and interpreting oncology efficacy and safety data.
• Knowledge of GCP and global regulatory requirements for oncology clinical trials.
• Excellent skills in medical and scientific writing.
• Demonstrated success in strategic thinking, including driving major innovations with positive patient outcomes.
• Proven ability to build and lead multidisciplinary project teams in a global matrix environment.
• High personal ethical standards and a strong commitment to improving patient outcomes in malignancies.
• Excellent written and spoken English communication and presentation skills.
• Proficient in standard office IT tools.

Nice to have

• Board certification in an oncology specialty and a PhD in a scientific field are preferred.