Executive Clinical Program Leader, Translational Clinical Oncology

Executive Clinical Program Leader, Translational Clinical Oncology
Company:

Novartis


Executive Clinical Program Leader, Translational Clinical Oncology

Details of the offer

Education:
MD or DO degree required;
Board-certification in an Oncology specialty

Required Experience:
5-10 years 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

Why consider Novartis?
799 million. That's how many lives our products touched in 2019. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
Imagine what you could do at Novartis!
1 purpose...to reimagine medicine! NIBR is seeking a Hematology expert who can help lead the heme strategy in Translational Clinical Oncology, oversee the heme portfolio and interface with late development and research. This is a very exciting opportunity to join TCO.
Role Purpose:To provide strategic medical guidance for and lead the development of multiple experimental oncology agents in the TCO portfolio, beginning with input to early Target identification and continuing through to the Development Decision Point. Provide strategic guidance to the oncology research portfolio and formulate actionable development plans with the Global Development Organization to ensure rapid and seamless decision making and transitions of molecules in the Oncology Portfolio.
Major Responsibilities:
Oversee and implement clinical strategy of multiple molecules that are advancing to clinical testing ensuring that robust and comprehensive development plans are in place and implemented.
Responsible for high quality documents for programs and studies under supervision including but not limited to protocol, IBs, and health authority responses
Provide senior leadership and clinical input to clinical studies under his or her responsibility. Provide leadership to effectively integrate your medical knowledge with expertise of colleagues in a wide range of other disciplines (e.g., Clinical Pharmacology, Biostatistics) to optimize the clinical development strategy
Lead Early Program Teams (EPT) for 1-2 program studies beginning at approval to conduct GLP toxicology studies to enable the start of clinical development, defining a strategies for Proof-of-Concept and development decision points. Provide oversight to direct reports who are leading EPTs
Provide early clinical development strategy that foresees and supports subsequent registration trials by working closely across the organization.
Oversee external collaborations partnering with associates from research, project management, and strategic alliance including leadership in steering committee oversight
Play leadership roles in early and late development committees and initiatives such as Target ID and Validation and Disease Area strategies by actively contributing strategic advice and to the decision making process and internal committees such as PRC.
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.

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.
Internal Number:74928377


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