Executive Clinical Program Leader, Translational Clinical Oncology

299726BR
Executive Clinical Program Leader, Translational Clinical Oncology

Job Description

1 purpose...to reimagine medicine! NIBR is seeking a board-certified (or equivalent) Nuclear Medicine Radiologist, Radiation Oncologist, or Hematologist-Oncologist to lead early clinical development of the Radioligand therapy portfolio in Translational Clinical Oncology (TCO) in collaboration with colleagues in the Global Development Organization, RLT drug discovery and oncology research groups. This is a very exciting opportunity to join TCO.

Role Purpose: To provide strategic medical guidance for and lead the development of multiple experimental Radioligand therapy (RLT) agents in the TCO portfolio, beginning with input on early target identification and continuing through to the Development Decision Point. Provide strategic guidance to the RLT 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 RLT portfolio.

Major Responsibilities:
•Oversee and implement clinical strategy of multiple imaging / diagnostic and therapeutic pipeline agents 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 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 the protocol review committee (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 Hematology-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.

Minimum requirements

Work Location Flexible: open to Cambridge, MA OR Basel Switzerland

Desirable Requirements:
Education:
*MD or DO degree required;
*Board-certification in Hematology-Oncology, Nuclear Medicine or Radiation Oncology

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 or substantial clinical experience as a Nuclear Medicine Physician in a hospital setting
•Interpretation of preclinical data in hematology/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!

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
NIBR
Oncology NIBR
USA
Cambridge, MA
NIBRI
Research & Development
Full Time
Regular
No