Clinical Program Leader - East Hanover, NJ | Biospace
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Clinical Program Leader

Novartis Oncology

East Hanover, NJ
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

To provide strategic medical guidance for and lead the development of experimental oncology agents in the Translational Clinical Oncology portfolio, beginning with the Candidate Selection Phase of preclinical development and continuing through clinical Proof-of-Concept (PoC).

•   Lead the Early Program Teams for your studies, reporting to the clinical head and Translational Clinical Oncology Leadership Team. You begin at sPOC approval (approval to conduct GLP toxicology studies to enable the start of clinical development) and continue clinical trials needed to demonstrated Proof-of-Concept •   Provide strategic medical guidance for the development of new oncology agents (small molecules and biologics) that are in preclinical development, typically beginning at the Candidate Selection Phase •   Create clinical development strategies for new oncology agents that are within the Candidate Selection Phase to Proof-of-Concept timeframe. The development strategy combines the Clinical Program Leader’s medical knowledge with expertise of colleagues in a wide range of other disciplines (e.g., Clinical Pharmacology, Biostatistics) to optimize the clinical development strategy •   Although registration studies are not within the responsibility of Translational Clinical Oncology, the Clinical Program Leader provides an early clinical development strategy that foresees and supports subsequent registration trials •   Integrate preclinical information (pharmacology, toxicology, pharmacokinetics) and interpret implications for clinical development as articulated in the Investigator’s Brochure and first-in-human protocol •   Collaborate with clinical scientists to develop clinical protocols for Translational Clinical Oncology compounds and develop instruments needed to implement, interpret and report them (e.g., case report forms, report and analysis plans, clinical study reports) •   Apply medical knowledge to guide the safe, ethical and efficient conduct of own trials. Strives to maintain or exceed compliance obligations for Good Clinical Practice guidelines and Novartis Standard Operating Procedures •   Liaise with outside experts, investigators, and regulatory authorities in Oncology and represents projects to those groups and authorities •   Write and review abstracts/manuscripts, etc. for presentation/publications at internal/external meetings. •   Participate in task forces to support continuous improvement and other management objectives
EEO Statement   The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.


MD or DO degree required Board-certification in an Oncology specialty strongly preferred As required •   3-5 pharma/biotech industry experience in oncology clinical trials and the equivalent term experience in an academic setting. In case of no industry experience, substantially longer academic experience in translational oncology and substantial clinical study experience •   Interpretation of preclinical data in oncology (molecular biology, pharmacology, pharmacokinetics, and toxicology) •   Working 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 relating to clinical trials and oncology •   Excellent medical/scientific writing skills •   Effective written and oral communication skills •   Proven ability to manage and develop a team •   Excellent personal ethical integrity and a commitment to improving the outcomes for patients with malignancies