Physician Scientist/ Clinical Program Leader (MD) job in East Hanover
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
Novartis Institutes for BioMedical Research (NIBR) is seeking a strong and innovative Physician Scientist to join our Translational Clinical Oncology (TCO) team as a Clinical Program Leader (CPL)|
At NIBR, a CPL provides strategic medical guidance for and to the lead the development of experimental oncology agents in the TCO portfolio, beginning with the candidate selection phase (CSP) of preclinical development and continuing through clinical proof-of-concept (PoC).
Major activities include:
• Lead the Early Program Teams (EPTs), reports to clinical head and TCO LT
• Provide 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).
• 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., Oncology Biomarkers and Imaging, Clinical Pharmacology, Biostatistics) to optimize the clinical development strategy.
• Although registration studies are not within the responsibility of TCO, the CPL in TCO must provide an early clinical development strategy that foresees and supports subsequent registration trials
• Lead 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.
• Integrate preclinical information (pharmacology, toxicology, pharmacokinetics) and interprets its implications for clinical development, as articulated in the Investigator's Brochure and first-in-human protocol.
• Collaborate with clinical scientists to develop clinical protocols for TCO 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).
• Apply 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.
• Liaise with outside experts, investigators, and regulatory authorities in the field of oncology, and represents his or her projects to those groups and authorities.
• Write and review abstracts/manuscripts, etc. for presentation/publications at internal/external meetings.
• Participate in task forces to support continuous improvement and other management objectives.• MD or DO degree required. Board-certification in an oncology specialty is preferred.
• 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