Senior Clinical Program Leader

Job Description Summary

About the role:

#LI-Remote

Help us ensure that safe, effective and innovative treatments reach patients as quickly as possible. The Senior Clinical Program Leader (Senior CPL) will play a critical role in overseeing the planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations.

 

Job Description

Key Responsibilities:

• Provides strategic medical guidance for the development of new oncology agents that are in preclinical development, typically beginning at the development candidate (DC) phase. Accountable for Translational Clinical Oncology (TCO) aspects of one or more global drug development programs. Establish and approve scientific methods for design and implementation of clinical protocols, data collection systems and final reports. 
• Evaluation of external opportunities for potential business development purposes
• Responsible for creating a clinical development strategy for new oncology agents. The development strategy combines the Clinical Program Leader's (CPL) medical knowledge with the expertise of colleagues in a wide range of other disciplines (e.g. Biomarkers, 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
• Leads Biomedical Research Program Teams (BPTs), beginning at the time of approval to conduct Good Laboratory Practices (GLP) toxicology studies to enable the start of clinical development, and continuing through those clinical trials. May lead multiple global project teams. 
• Support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of confidentiality agreements and clinical agreements.
• Responsible for development of the Integrated Development Plan (IDPA).
• 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. 
• Collaborates 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). 
• 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. 
• Liaises with outside experts, investigators, and regulatory authorities in the field of oncology, and represents his or her projects to those groups and authorities. Fosters communication with key opinion leaders and collaborating investigators. Acts as the medical monitor for one or more global clinical studies. Writes and reviews abstracts/manuscripts, etc. for presentation/publications at internal/external meetings. Participates in task forces to support continuous improvement and other management objectives. Mentors and serves as an educational resource across Novartis. Acts as a key resource for less experienced CPLs in TCO.

 

Essential Requirements:

• The ideal location for this role is the Cambridge, MA site but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to the Cambridge, MA site for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 10% travel.
•  3-5+ years of experience leading complex early phase Oncology clinical programs from the pharma/biotech industry; Experience with the interpretation of preclinical data in oncology (molecular biology, pharmacology, pharmacokinetics, and toxi