Clinical Development Medical Director
Job Description 10 major new medicines planned for launch over the next few years creating new career opportunities for those who want to make a direct impact on patients at scale improving people's lives. Novartis Hematology/Oncology has a renowned history in hematology and oncology of developing transformative therapies for patients.
As the Clinical Development Medical Director (CDMD), you will lead the planning and management of the assigned clinical program(s) from an end-to-end clinical development perspective and drive execution of the plan, enable an empowered organization, which can navigate in a matrix environment and quickly adjust to business needs.
In Clinical Development Oncology & Hematology, our aim is to design innovative, patient friendly clinical development plans to rapidly bring outstanding treatments to patients, caregivers and healthcare systems. We are striving to develop treatments for Lung, Breast & Prostate Cancers, MDS & AML, CML and sickle-cell disease, and are pushing the boundaries of innovation with CAR-T and Radioligand therapies.
What you'll be doing: (but not limited to)
* Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program
* Lead development of clinical sections of trial and program level regulatory documents
* Drive execution of the program and/or clinical trial in partnership with global line functions, assigned Global Trial Directors, and regional/country medical associates
* Support the Global Program Clinical Head in ensuring overall safety of the molecule for the assigned section, and may act as a core member of the Safety Management Team, supporting overall program safety reporting in collaboration with Patient Safety colleagues
* Support the Clinical Development Head by providing medical input into the Clinical Development Plan, Integrated Development Plan and Clinical Trial Protocol reviews. and contributing to development of disease clinical standards for new disease areas
* As a medical specialist, supporting the GPCH or CDH in interactions with external and internal partners and decision boards
* May work with the Novartis Institute of Biomedical Research/ Translational Medical Sciences to drive transition of pre-PoC projects to DDP and with BD&L including target identification and due diligences together with other medical matters, as needed. EEO Statement 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 equivalent medical degree is required*** in addition to sophisticated knowledge and clinical training in medical/scientific areas
* 3+ years minimum in clinical research or drug development
* Working knowledge of Hematology/Oncology with a proven track record to interpret, discuss and present efficacy & safety data relating to clinical trials
* Solid understanding of GCP, clinical trial design, statistics, and regulatory and clinical development processes
* Demonstrated ability to establish effective scientific partnerships with key partners
* The ideal location for this role is East Hanover, NJ, but remote work may be possible (there may be restrictions based on legal entity). Please note that this role would not provide relocation as a result. If the associate is remote, all home office expenses and travel/lodging to the East Hanover or corporate site for periodic live meetings will be at the employee's expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.
Highly Desired:
* * Clinical practice experience 4 years (including residency) preferred
* Previous global people management experience is preferred, though this may include management in a matrix environment.
Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.
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
Why Novartis?
769 million lives were touched by Novartis medicines in 2020, 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!
While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com. Division Global Drug Development Work Location East Hanover, NJ Company/Legal Entity Novartis Pharmaceuticals Functional Area Research & Development
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Novartis Group Companies
July 06, 2022