Leads the EPT, reports to clinical head and OTM LT
Provides strategic medical guidance for the development of new oncology agents (both small molecules and biologics) that are in preclinical development, typically beginning at the candidate selection phase (CSP).
The CPL is specifically responsible for creating a clinical development strategy for new oncology agents that are within the CSP to PoC timeframe. The development strategy combines the CPL’s medical knowledge with the expertise of colleagues in a wide range of other disciplines (e.g., Clinical Pharmacology, Biostatistics) to optimize the clinical development strategy.
Although registration studies are not within the responsibility of OTM, the CPL in OTM must provide an early clinical development strategy that foresees and supports subsequent registration trials
The CPL is the leader for Early Program Teams (EPTs), beginning at the time of sPOC approval (approval to conduct GLP toxicology studies to enable the start of clinical development) and continuing through those clinical trials needed to demonstrated PoC.
The CPL integrates preclinical information (pharmacology, toxicology, pharmacokinetics) and interprets its implications for clinical development, as articulated in the Investigator’s Brochure and first-in-human protocol.
The CPL collaborates with clinical scientists to develop clinical protocols for OTM compounds and to develop the instruments needed to implement, interpret and report them (e.g., case report forms, report and analysis plans, clinical study reports).
The CPL applies his or her medical knowledge to guide the safe, ethical and efficient conduct of the trials under his or her responsibility. He or she is knowledgeable in Good Clinical Practice guidelines and Novartis Standard Operating Procedures and strives to maintain compliance with them.
The CPL liaises with outside experts, investigators, and regulatory authorities in the field of oncology, and represents his or her projects to those groups and authorities.
The CPL writes and reviews abstracts/manuscripts, etc. for presentation/publications at internal/external meetings.
The CPL participates in task forces to support continuous improvement and other management objectives.
MD or DO degree required. Board-certification in an oncology specialty is preferred. Fluent English (oral and written) Needs 3-5 pharma/biotech industry experience in oncology clinical trials and the equivalent term experience in the academic setting In case of no industry experience, substantially longer academic experience in translational oncology and substantial clinical study experience. Must have facility with the interpretation of preclinical data in oncology (molecular biology, pharmacology, pharmacokinetics, and toxicology) Working 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 relating to clinical trials and oncology Excellent medical/scientific writing skills Effective written and oral communication skills Proven ability to manage and develop a team Excellent personal ethical integrity and a commitment to improving the outcomes for patients with malignancies
Novartis is an EEO/AA employer M/F/D/V. This position will be filled at a level commensurate with experience.