343661BR
Apr 14, 2022
Switzerland

Job Description

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.

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.

The Associate Clinical Development Medical Director (aCDMD) is responsible for leading the planning and management of the assigned clinical program(s) from an end-to-end clinical development perspective. As Associate CDMD, you will have oversight of the clinical development for the assigned programs and drive execution of the 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 of the 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 specialist, supporting the (Sr.) GPCH or CDH in interactions with external and internal partners 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.

Diversity & Inclusion / EEO

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

Minimum Requirements

MD or equivalent medical degree is required*** in addition to sophisticated knowledge and clinical training in medical/scientific area

Clinical practice experience ≥ 4 years (including residency) preferred
• Fluent oral and written English
• 3 years experience in clinical research or drug development
• Working knowledge of gastrointestinal disease area is desirable, with a proven track record to interpret, discuss and present efficacy & safety data relating to clinical trial(s)
• Demonstrated ability to establish effective scientific partnerships with key partners
• Solid understanding of GCP, clinical trial design, statistics, and regulatory and clinical development processes


**Some restrictions to flexible working models may apply and will be discussed at interview if applicable

*** For PharmD & PhD qualified applicants, please refer to our posting for (Associate/Snr)Clinical Development Director, position number 323864BR

Why consider Novartis?

766 million. That’s how many lives our products touched in 2021. 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

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
OHD GDD
Switzerland
Basel
USA
Ireland
India
Human Resources
Full Time
Regular
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343661BR

Associate Clinical Development Medical Director - GI (**80-100%)

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