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수평: Executive
직업 종류: Full-time
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작업 내용
Job Description5600 scientists working on 340 discovery programs in 8 disease areas focusing on 90 new molecular entities makes Novartis the premier place to develop your career as a pharmaceutical professional. If you are curious, scientifically minded, and want to positively impact society by speeding delivery of novel therapies to needy patients, then look no further, NIBR is the place to be.
In the role of Therapeutic Area (TA) Head, Autoimmunity, Transplantation & Inflammation (ATI) Preclinical Safety (PCS) you will be responsible for delivering the safety assessment strategy and scientific excellence for the ATI disease area within Preclinical Safety. You will drive the strategy and oversee the implementation of preclinical drug development activities, and all scientific activities within PCS to ensure optimization/maintenance/issue resolution re. to the R&D portfolio. As a globally recognized senior preclinical expert you will lead the PCS TA strategy team comprised of drug development experts to ensure optimal support of R&D projects in terms of science, quality and timeliness.
Your main accountabilities will be:
- Responsible for preclinical safety assessment and development strategy of PCS TA. Contribute to global PCS strategy on safety assessment and drug development.
- Provide expert leadership and accountability for coordinated scientific and operational review of:
- Preclinical Development Plan(s) and Safety Profiling Plan(s) (SPP)
- PCS regulatory documents (IB, IND, CTD, BBs, HA questions, etc.)
- Study Protocol synopses
- New study designs/ endpoints/ biomarker strategies for disease area
- Innovative within and cross project data utilization
- Innovative technologies/ drug development approaches
- Provide thought leadership and lead continuous improvement in safety assessment strategies and project support in the TA and contribute to same in global PCS.
- Provide expert input into due diligence assessments of potential licensing and acquisition projects and provide review of preclinical due diligence reports for the TA.
- Oversight of all preclinical development activities (including timelines) for all projects managed by the PCS TA from NTRC to phase IV programs. Oversight of resources planning for DA (Ex-POC) and DF (Phase 2-marketing)
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 will bring to the role:
The ideal candidate will possess a PhD in pharmacology, toxicology or a related biological science; MD with appropriate experience, DVM with appropriate training and experience. PharmD or equivalent with a strong biological background or equivalent work experience.
Desired Experience:
- 5 plus years’ experience in a nonclinical safety scientific discipline (e.g. Study Director, Study Monitor, Study Pathologist, Investigative Toxicology)
- Minimum of 10 years’ experience as a full-time nonclinical safety PTM (regulatory stage projects, in Novartis or in a similar organization ex-Novartis)
- Ability to mentor others in nonclinical safety issue resolution
- Ability to communicate (written and verbal) and negotiate with Health Authorities on complex issues
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!
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
Division
NIBR
Business Unit
Translational Medicine
Country
Switzerland
Work Location
Basel
Company/Legal Entity
Novartis Pharma AG
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
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마감 시간: 05-05-2024
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