Associate Clinical Development Medical Director
vor 11 Stunden
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 Oncology has a renowned history in hematology and oncology of developing transformative therapies for patients.
- As the Associate Clinical Development Medical Director, you will be the clinical leader of defined program level activities such as submission activities, briefing books or sophisticated trials, under the leadership of the Global Program Clinical Head. You may lead a section of a clinical program, an indication, new formulation, or specific development phase. 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:
- Provide clinical leadership and medical strategic input for all clinical results in the assigned project or section of a clinical program. Clinical deliverables may include clinical sections of individual protocols consistent with the Integrated Development Plans, clinical data review, program standards, clinical components of regulatory documents/registration dossiers, and publications
- Lead development of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
- Drive execution of the section of the clinical program in partnership with line functions, assigned Global Trial Director, and regional/country medical associates
- Coordinate/conduct ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert
- May be the Program Manager of other associates Support GPCH in ensuring safety of the molecule for the assigned section, may be a core member of the Safety Management Team, and support overall program safety reporting (e.g., Periodic Safety Update Reports, Drug Safety Update Reports and other safety related documents) in collaboration with Patient Safety
- Work with the Clinical Development Head providing medical input into the Development Plan and Clinical Trial Protocol reviews and driving development of disease clinical standards for new disease areas.
- Support the GPCH or CDH in interactions with external partners (authorities, opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal partners (CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, Health Economics & Outcome Research), and decision boards
- Work with NIBR (Novartis Institute of Biomedical Research)/Translational Medical Sciences to drive transition of pre-PoC projects to DDP and with Business Development & Licensing
**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._
**Minimum requirements**
- What you’ll bring to the role:
- MD or equivalent medical degree required. Extensive knowledge and clinical training in a medical/scientific area required, with Medical Board Certification preferred.
- 3+ years of direct involvement in clinical research or drug development in an academic or industry environment or equivalent, spanning clinical activities preferably in Phases I through IV. Having contributed to and accomplished in all aspects of conducting clinical trials in a global/matrix environment in pharmaceutical industry or equivalent
- Minimum 5 years of clinical experience in oncology
- Experience in Clinical Trials
- Why Novartis?
- 767 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
**Division**
- Global Drug Development
**Business Unit**
- OHD GDD
**Country**
- Switzerland
**Work Location**
- Basel
**Company/Legal Entity**
- Novartis Pharma AG
**Alternative Country 1**
- USA
**Functional Area**
- Research & Development
**Job Type**
- Full
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