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Clinical Program Leader / Director (MD / DO)

Cambridge, Massachusetts, United States
Closing date
Nov 29, 2022

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Full Time
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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) / Director (MD / DO), 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.

Your key responsibilities:
Your responsibilities include, but are not limited to:
• 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 their 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 their 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.

This position will be located at the Cambridge, MA site and will not have the ability to be located remotely. This position will not require travel as defined by the business (domestic and/ or international).

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

What you’ll bring to the role:
• 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)
• Solid understanding 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 Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or 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.

The pay range for this position at commencement of employment is expected to be between $257,600 and $386,400/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
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