Jan 07, 2022

Job Description

6000! That’s the number of associates in the Novartis Institutes for BioMedical Research (NIBR). This division is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients.

As the Clinical Program Leader (CPL), you will provide strategic medical guidance and lead the development of experimental oncology agents in the Translational Clinical Oncology (TCO) portfolio, beginning with the candidate selection phase of preclinical development and continuing through clinical proof-of-concept.

You will:

• Lead the Early Program Team (EPT), report to Clinical Site Head
• Build a clinical development strategy for new oncology agents that are within the candidate selection to proof-of-concept (PoC) timeframe. The development strategy combines the CPL’s medical knowledge with the expertise of colleagues in a wide range of other fields (e.g., Clinical Pharmacology, Biostatistics) to optimize the clinical development strategy.
• Provide an early clinical development strategy that foresees and supports registration trials
• Lead the EPTs, from time of approval to conduct Good Laboratory Practices toxicology studies to enable the start of clinical development through those clinical trials needed to demonstrate PoC.
• Integrate preclinical information (pharmacology, toxicology, pharmacokinetics) and interprets its implications for clinical development, as articulated in the Investigator’s Brochure and first-in-human protocol.
• Collaborate with clinical scientists to develop protocols for TCO compounds and to develop the 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 the trials under his or her responsibility. Be knowledgeable in Good Clinical Practice (GCP) guidelines and Novartis Standard Operating Procedures and strive to maintain compliance with them.
• Liaise with outside specialists, investigators, and regulatory authorities in the field of oncology, and represents his or her 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.


Diversity & Inclusion / EEO

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 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 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.

Minimum Requirements

You will bring:
• MD or DO degree required. Board-certification in an oncology specialty is preferred. Additional laboratory-based science training is preferred.
• 3-5 years of pharma/biotech industry experience in oncology clinical trials and the equivalent term experience in the academic setting. In case of no industry experience, substantially longer academic experience in translational oncology and substantial clinical study experience.
• Ability to interpret preclinical data in oncology (molecular biology, pharmacology, pharmacokinetics, and toxicology)
• Working knowledge of the application of Pharmacokinetic / Pharmacodynamic 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 track record of managing and developing a team
• Excellent personal ethical integrity and a dedication to improving the outcomes for patients with malignancies

Why consider Novartis?

769 million. That’s how many lives our products touched in 2020. 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.

We are Novartis. Join us and help us reimagine medicine.

Accessibility and reasonable accommodations:

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.


Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Oncology TCO NIBR
Cambridge, MA
Research & Development
Full Time
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Clinical Program Leader / Director (MD / DO)

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