Clinical Program Leader (CPL)

Location: Cambridge, MA. #LI-OnsiteExperience will determine which level 6 (Senior CPL or CPL) is appropriate after interview process based on skills and experience. Help us ensure that safe, effective and innovative treatments reach patients as quickly as possible! 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. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports; evaluates external opportunities for potential business development purposes. Creates a clinical development strategy for new oncology agents, combining the Clinical Program Leader’s medical knowledge with the expertise of colleagues in biomarker discovery, clinical pharmacology and biostatistics to optimize the strategy. Even though registration studies are not within the responsibility of TCO, provides an early clinical development strategy that foresees and supports subsequent registration trials. Leads Biomedical Research Program Teams (BPTs), beginning at 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. Supports new and ongoing clinical research and clinical trials, ensuring efficient and timely processing of confidentiality agreements and clinical agreements. Responsible for development of the Integrated Development Plan (IDPA), integrating preclinical information and interpreting its implications for clinical development; collaborates with clinical scientists to develop clinical protocols and the instruments needed to implement, interpret and report them (e.g., case report forms, report and analysis plans, clinical study reports). Applies medical knowledge to guide the safe, ethical and efficient conduct of the trials under his or her responsibility, knowledgeable in Good Clinical Practice guidelines and Novartis SOPs and strives to maintain compliance. Liaises with outside experts, investigators and regulatory authorities in the field of oncology, represents 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 for presentation/publications at internal/external meetings, and 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 Position located at Cambridge, MA site; not remotely locatable. Approximately 10% travel (domestic and/or international). MD or DO degree with additional laboratory‑based training; board certification or equivalent expertise in an oncology sub‑specialty. 1-3 years of experience (or 3-5+ years for Senior) leading complex early‑phase oncology clinical programs from pharma/biotech industry and/or academia; capable of interpreting preclinical data in oncology (molecular biology, pharmacology, PK/PD, toxicology). Working knowledge of PK/PD and biostatistics applied to clinical development and clinical trials. Proven ability to analyze and interpret efficacy and safety data related to oncology; knowledge of GCP and worldwide regulatory requirements. Excellent medical/scientific writing, oral communication and presentation skills. Proven ability to manage and develop a team; experienced across multiple indications; works effectively in multidisciplinary teams; innovative and independent leader. Inspires others, has strong passion for translational science, high ethical integrity and commitment to improving outcomes for patients with malignancies. Desirable Requirements Pharma/biotech industry background. PhD. Exceptional creative thinking and fearless in designing new approaches to proof‑of‑concept studies. Salary and Benefits Expected salary range at commencement of employment: $248,500.00 – $461,500.00. Final pay will depend on location, experience, skills and other factors. Total compensation may include sign‑on bonus, restricted stock units, discretionary awards and a full range of medical, financial and other benefits (401(k) eligibility, paid time off, vacation, sick, parental leave, etc.). Employees will be in an at‑will position; the company reserves the right to modify base salary or other discretionary payments at any time. #J-18808-Ljbffr Novartis Farmacéutica