346128BR
May 27, 2022
USA

Job Description

Over 108,000. That’s how many US patients our oncology products touched in 2018. Novartis is deeply committed to transforming the lives of people living with solid tumors, blood cancers and serious or life-threatening blood disorders. We believe that anyone living with these conditions has the right to a life free from pain, free from symptoms and free from disease - this is our vision for the future.

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 adjust quickly 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.

Your key responsibilities: (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.

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 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

Desirable:
• Clinical practice experience ≥ 4 years (including residency) preferred
• Previous global people management experience is preferred, though this may include management in a matrix environment.

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.

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 [email protected].
Global Drug Development
OHD GDD
USA
East Hanover, NJ
Research & Development
Full Time
Regular
No
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346128BR

Clinical Development Medical Director

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