Senior Oncology Clinical Program Lead

U175 (FCRS = US175) Novartis Institutes for BioMedical Research, Inc.; Cambridge (MA); Hybrid; USD 249,000 - 462,000; Full time

Job summary

Novartis Institutes for BioMedical Research, Inc. in Cambridge, MA is seeking a Senior CPL or CPL to provide strategic medical leadership for oncology programs from preclinical entry through Transition Decision Point, with a hybrid onsite arrangement.

You will develop clinical strategies, lead cross-functional teams, supervise early development activities, and ensure rigorous data interpretation and regulatory compliance in pursuit of potential registrational trials.

Qualifications

• MD or DO degree Board-certification in an oncology specialty and PhD-level science are preferred
• Fluent English – Oral and written
• At least 2 years of pharmaceutical/biotech industry experience in oncology clinical trials plus the equivalent duration experience from an academic medical center.
• If limited or no Pharmaceutical industry experience, then comparable senior academic experience in translational oncology and clinical research
• Experience within RLT preferred
• Recognized as an expert in your field by external medical experts.
• External candidates have a substantial record of publication and international recognition
• Excellent interpretation of oncology preclinical data (molecular biology, pharmacology, pharmacokinetics, and toxicology)
• Strong knowledge of the application of PK/PD and biostatistics to clinical development and clinical trials
• Proven ability to analyze and interpret efficacy and safety data relating to oncology
• Knowledge of GCP and world-wide regulatory requirements for clinical trials and oncology
• Excellent medical/scientific writing skills
• Successful track record of strategic thinking
• Proven ability to develop and inspire project/line/matrix multidisciplinary teams in a global environment
• Excellent personal ethical integrity and a commitment to improving the outcomes for patients with malignancies
• Excellent written and oral English communication/presentation skills
• Strong office IT skills

Responsibilities

• Provide strategic medical leadership to project teams for oncology development from preclinical to TDP
• Create development strategies for PE/DC to TDP
• Deliver solutions across functions and global projects
• Develop early clinical development strategies to support registration trials
• Lead IDPA development with DALs, DEV, S&G, and Commercial
• Lead Biomedical Research Early Program Teams to enable clinical development

Skills

Fluent English – Oral & written

Oncology clinical trials experience

Pharmaceutical/biotech industry

RLT experience

External recognition by peers

Publication record

Education

MD or DO degree

PhD-level science

Job description

Novartis Institutes for BioMedical Research, Inc. in Cambridge, MA is seeking a Senior CPL or CPL to provide strategic medical leadership for oncology programs from preclinical entry through Transition Decision Point, with a hybrid onsite arrangement.

You will develop clinical strategies, lead cross-functional teams, supervise early development activities, and ensure rigorous data interpretation and regulatory compliance in pursuit of potential registrational trials.