Clinical Program Leader / Senior Clinical Program Leader, Translational Clinical Oncology (Dual Posting)

Novartis•Cambridge, MA

2d•Onsite

About The Position

About the role: #LI-Onsite Help us ensure that safe, effective and innovative treatments reach patients as quickly as possible! The Clinical Program Leader (CPL) / 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.

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).
This is a dual posting. The final level & title of the offer role would be determined by the hiring team based on the skills, experience & capabilities required to perform the role at the level the role has been offered (Clinical Program Leader / Senior Clinical Program Leader): Clinical Program Leader: 1-3 years of experience leading complex early phase Oncology clinical programs from the pharma/biotech industry and/or academia; Experience with the interpretation of preclinical data in oncology (molecular biology, pharmacology, pharmacokinetics, and toxicology)
Senior Clinical Program Leader: 3-5+ years of experience leading complex early phase Oncology clinical programs from the pharma/biotech industry and/or academia; 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

Nice To Haves

Pharma / biotech industry preferred
PhD

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.