Novartis
Senior Clinical Program Leader
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. 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. Evaluation of external opportunities for potential business development purposes. Responsible for creating a clinical development strategy for new oncology agents. 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. 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. Collaborates with clinical scientists to develop clinical protocols for TCO compounds and to develop the instruments needed to implement, interpret and report them. Applies his or her medical knowledge to guide the safe, ethical and efficient conduct of the trials under his or her responsibility. Liaises with outside experts, investigators, and regulatory authorities in the field of oncology, and represents his or her projects to those groups and authorities. Essential Requirements
This position will be located at the Cambridge, MA site and will not have the ability to be located remotely. This position will require approximately 10% travel as defined by the business (domestic and/or international). 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 toxicology). MD or DO degree and additional laboratory-based training are required; Board certification (or equivalent expertise) in an Oncology sub-specialty. Working knowledge of the application of pharmacokinetic/pharmacodynamic (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 Good Clinical Practices (GCP) and world-wide regulatory requirements relating to clinical trials and oncology. Excellent medical/scientific writing and oral communication/presentation skills. Proven ability to manage and develop a team; Used to working successfully across more than one indication; Excellent teamwork in multidisciplinary settings; Creative and independent leader; Innovative and fearless in designing new approaches to PoC studies and in critical thinking; Looks beyond what is evident and visible. Inspires others and strong passion for translational science; Excellent personal ethical integrity and a commitment to improving the outcomes for patients with malignancies. Desirable Requirements
Experience from an academic medical center. PhD. The pay range for this position at commencement of employment is expected to be between: $236,600 and $439,400/year for Senior CPL; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. The Novartis Group of Companies is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an email to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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. 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. Evaluation of external opportunities for potential business development purposes. Responsible for creating a clinical development strategy for new oncology agents. 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. 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. Collaborates with clinical scientists to develop clinical protocols for TCO compounds and to develop the instruments needed to implement, interpret and report them. Applies his or her medical knowledge to guide the safe, ethical and efficient conduct of the trials under his or her responsibility. Liaises with outside experts, investigators, and regulatory authorities in the field of oncology, and represents his or her projects to those groups and authorities. Essential Requirements
This position will be located at the Cambridge, MA site and will not have the ability to be located remotely. This position will require approximately 10% travel as defined by the business (domestic and/or international). 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 toxicology). MD or DO degree and additional laboratory-based training are required; Board certification (or equivalent expertise) in an Oncology sub-specialty. Working knowledge of the application of pharmacokinetic/pharmacodynamic (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 Good Clinical Practices (GCP) and world-wide regulatory requirements relating to clinical trials and oncology. Excellent medical/scientific writing and oral communication/presentation skills. Proven ability to manage and develop a team; Used to working successfully across more than one indication; Excellent teamwork in multidisciplinary settings; Creative and independent leader; Innovative and fearless in designing new approaches to PoC studies and in critical thinking; Looks beyond what is evident and visible. Inspires others and strong passion for translational science; Excellent personal ethical integrity and a commitment to improving the outcomes for patients with malignancies. Desirable Requirements
Experience from an academic medical center. PhD. The pay range for this position at commencement of employment is expected to be between: $236,600 and $439,400/year for Senior CPL; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. The Novartis Group of Companies is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an email to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.