About the job
Over 108,000. That’s how many US patients our oncology products touched in 2018. And while we’re proud of that, 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 empowered to ask new questions, make bolder decisions and take smarter risks. In Clinical Development & Analytics, our aim is to design innovative, patient friendly clinical development plans to rapidly bring outstanding treatments to patients, caregivers and healthcare systems. To achieve this goal we rely on a dedicated team of experts, including the Clinical Development Medical Director for Oncology.
The Senior Clinical Development Medical Director (CDMD) for Oncology is responsible for leading the strategic planning and management of the assigned clinical program(s) from an end-to-end clinical development perspective. As Senior CDMD, you will have oversight of the clinical development for the assigned programs and drive execution of the clinical development plan. In addition, you will enable an empowered organization, which can navigate in a matrix environment and adjust quickly to business needs.
Your responsibilities will include:
Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program
Leading development of clinical sections of trial and program level regulatory documents
Driving execution the assigned clinical program and/or clinical trial in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, where applicable
Supporting (Senior) Global Program Clinical Head (GPCH) in ensuring overall safety of the molecule for the assigned section, and may act as a core member of the Safety Management Team (SMT), supporting overall program safety reporting in collaboration with Patient Safety colleagues
Supporting the Clinical Development Head (CDH) by providing medical input into Clinical Development Plan (CDP), Integrated Development Plan (IDP) and Clinical Trial Protocol (CTP) reviews, and contributing to/driving development of disease clinical standards for new disease areas
As a medical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards
May work with NIBR (Novartis Institute of Biomedical Research/ Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligences together with other medical matters, as needed.
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.
What you bring to the role:
- MD or equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/scientific area; Clinical practice experience 4 years (including residency) preferred
- Minimum of 7 years of experience in clinical research or drug development
- Experience in an academic or industry environment spanning clinical activities in Phases I through IV required.
- 2 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry required.
- Working knowledge of Oncology is required, with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s)
- Demonstrated ability to establish effective scientific partnerships with key stakeholders
- Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
- Previous global people management experience is preferred, though this may include management in a matrix environment.
- Final job title and associated responsibilities will be commensurate with the successful candidates’ level of expertise.
- Some restrictions to flexible working models may apply and will be discussed at interview if applicable
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.
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Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
East Hanover, NJ
Research & Development
- Information Technology
- Total Years Experience 0-5
- Remote Work No remote work