Clinical Program Leader (CPL)

Novartis•Cambridge, MA

11d•$248,500 - $461,500•Hybrid

About The Position

The Clinical Program Leader (CPL) provides strategic medical guidance and leads the development of experimental oncology agents within the TCO portfolio. This role spans from the Portfolio Entry / Drug Candidate (PE / DC) phase of preclinical development through the Transition Decision Point (TDP). The specific level (Senior CPL or CPL) will be determined based on the candidate's skills and experience after the interview process. The CPL creates clinical development strategies, integrating medical knowledge with expertise from various disciplines to optimize the strategy. While registration studies are not directly managed, the CPL must establish an early clinical development strategy that supports subsequent registration trials. This includes developing the Integrated Development Plan Approval (IDPA) in collaboration with other teams. The CPL leads Biomedical Research Early Program Teams (BPTs) to facilitate the start of clinical development and continuing through clinical trials supporting TDP, potentially leading multiple global project teams. They integrate and interpret preclinical information (pharmacology, toxicology, pharmacokinetics) for clinical development, collaborate with clinical scientists to develop protocols and necessary instruments, and ensure the safe, ethical, and efficient conduct of trials in compliance with GCP and Novartis SOPs. The CPL also liaises with external experts, investigators, and regulatory authorities, represents projects to these groups, and writes/reviews abstracts and manuscripts. Participation in task forces for continuous improvement and operational responsibility for quality and compliance are also key aspects. Informal mentorship of less experienced CPLs may be provided.

Requirements

MD or DO degree
Board-certification in an oncology specialty and PhD-level science are preferred
Fluent English – Oral and written
At least 2 years of pharmaceutical/biotech industry experience in oncology clinical trials plus the equivalent duration experience from an academic medical center. If limited or no Pharmaceutical industry experience, then comparable senior academic experience in translational oncology and clinical research
Recognized as an expert in your field by external medical experts. External candidates have a substantial record of publication and international recognition
Excellent interpretation of oncology preclinical data (molecular biology, pharmacology, pharmacokinetics, and toxicology)
Strong knowledge of the application of 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 GCP and world-wide regulatory requirements for clinical trials and oncology
Excellent medical/scientific writing skills
Successful track record of strategic thinking
Proven ability to develop and inspire project/line/matrix multidisciplinary teams in a global environment
Excellent personal ethical integrity and a commitment to improving the outcomes for patients with malignancies
Excellent written and oral English communication/presentation skills
Strong office IT skills

Nice To Haves

Board-certification in an oncology specialty
PhD-level science

Responsibilities

Provides strategic medical and scientific leadership and expertise to all line functions on the project team for the development of new oncology agents (e.g., small molecules, biologics, radioligand therapies) that are in preclinical development, typically beginning at the PE / DC.
Creates clinical development strategies for new oncology agents within the PE/ DC to TDP timeframe, combining medical knowledge with expertise from other disciplines to optimize the strategy.
Delivers solutions within functions, across functions, and on global projects, developing an independent approach to TCO strategy.
Provides an early clinical development strategy that foresees and supports subsequent registration trials.
Develops 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 continuing through clinical trials needed to support TDP.
May lead multiple global project teams.
Integrates preclinical information (pharmacology, toxicology, and pharmacokinetics) and interprets 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 develop the instruments needed to implement, interpret and report them (e.g., case report forms, report and analysis plans, clinical study reports).
Applies own medical knowledge to guide the safe, ethical and efficient conduct of the trials under own responsibility.
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 oncology, and represents own projects to those groups and authorities.
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.
Operational responsibility for quality and compliance.
May provide informal mentorship to less experienced CPLs.