Clinical Program Lead (CPL) - RLT Focus

Job Description Summary Band Level 6 position located in Cambridge, MA. Hybrid work setting preferred, though onsite candidates are desirable. The role may fall under Senior CPL or CPL, determined after interview based on skills and experience. Responsibilities Provide strategic medical and scientific leadership to all line functions on the project team for the development of new oncology agents (small molecules, biologics, radioligand therapies) in preclinical development. Develop clinical development strategies for new oncology agents within the PE/DC to TDP timeframe, combining medical knowledge with expertise from Clinical Pharmacology, Biostatistics, and other disciplines. Deliver solutions across functions and on global projects, establishing an independent approach to TCO strategy. Prepare an early clinical development strategy that supports subsequent registration trials, even though registration studies are not within the CPL’s responsibility. Develop the Integrated Development Plan Approval (IDPA) in alignment with CPL Disease Area Leads (DALs), Development (DEV), Strategy & Growth (S&G), and Commercial teams. Lead Biomedical Research Early Program Teams (BPTs) to enable the start of clinical development and continuation through clinical trials needed to support TDP. Interpret preclinical information (pharmacology, toxicology, pharmacokinetics) and apply it to clinical development, articulated in the Investigator’s Brochure and First‑in‑Human protocol. Collaborate with clinical scientists to develop clinical protocols and design instruments needed for implementation, interpretation, and reporting, such as case report forms, analysis plans, and clinical study reports. Guide safe, ethical, and efficient conduct of trials under own responsibility, maintaining compliance with Good Clinical Practice (GCP) guidelines and Novartis Standard Operating Procedures. Liaise with outside experts, investigators, regulatory authorities, and represent projects to these groups. Write and review abstracts, manuscripts, and other scientific communications for presentation and publication at internal and external meetings. Participate in task forces to support continuous improvement and management objectives, with operational responsibility for quality and compliance. Provide informal mentorship to less experienced CPLs. Qualifications MD or DO degree with board certification in an oncology specialty; PhD‑level science preferred. Fluent in English (oral and written). At least two years of pharmaceutical/biotech industry experience in oncology clinical trials and equivalent experience from an academic medical center, or comparable senior academic experience in translational oncology and clinical research. Preferred experience in radioligand therapies. Extensive record of publication and international recognition, recognized as an expert by external medical experts. Outstanding interpretation of oncology preclinical data (molecular biology, pharmacology, pharmacokinetics, toxicology). Strong knowledge of PK/PD and biostatistics application to clinical development and trials. Proven ability to analyze and interpret efficacy and safety data in oncology. Comprehensive understanding of GCP and worldwide regulatory requirements. Excellent medical and scientific writing skills with a track record of strategic thinking. Demonstrated ability to develop and inspire multidisciplinary project teams in a global environment. High personal ethical integrity and commitment to improving patient outcomes. Strong written and oral English communication and presentation skills. Proficient IT skills. Compensation and Benefits The salary range is $248,500.00 – $461,500.00 USD per year, with additional performance‑based cash incentive and potential eligibility for annual equity awards. Eligible US‑based employees receive a comprehensive benefits package including health, life and disability insurance, 401(k) with company match, and a generous time‑off policy (vacation, personal days, holidays, and other leaves). EEO Statement 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, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and Reasonable Accommodations For reasonable accommodations to the application process or essential job functions, please contact View email address on click.appcast.io or call View phone number on click.appcast.io, including the job requisition number in your message. #J-18808-Ljbffr U175 (FCRS = US175) Novartis Institutes for BioMedical Research, Inc.