Medical Director, Translational Medicine Dermatology
Inseriert am: 03.06.2019
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Job ID269759BRPosition TitleMedical Director, Translational Medicine DermatologyApply to Job
Job Description
You will provide medical and scientific expertise and leadership in a role that significantly impacts the entire Novartis pipeline, transitioning programs from preclinical through early clinical and ultimately to full development via the Proof of Concept mechanism and driving the program after Proof of Concept by delivering key Profiling data to support regulatory submissions.
1. Drive success of early global programs, developing and implement strategies to achieve clinical Proof of Concept 2. If appropriate, drive success of late global programs by developing and implementing strategies that lead to clinical pharmacology; design mechanistic studies and profiling packages that meet regulatory requirements; support differentiated and competitive drug labeling
3. Provide scientific expert assessments and support for in-licensing opportunities including due diligence
This position is written for Director - we can also hire Associate Director for those with training and experience not yet at Director-level. An Associate Director role profile will be provided as appropriate.
- Translational Medicine / early clinical projects
In collaboration with Translational Medicine Therapeutic Area Head or experienced Translational Medicine Experts, develop high value decision-strategies for the Translational Medicine component of drug development projects from Research to clinical Proof of Concept in a single or multiple indications, including Parallel Indication Expansion-Proof of Concepts
• Lead global project teams through early First in Human and Proof of Concept phases to drive implementation of the Proof of Concept strategy
• Convene relevant internal and external leaders to consider the proposed approach to Proof of Concept
• Responsible for clinical portions of the Integrated Development Plan including the Clinical Development Plan and Clinical Pharmacology Plan
• In collaboration with research scientists, identify, develop, and implement strategy for preclinical support of clinical program-related scientific objectives. This includes assessment of medical need, proposal of clinical development pathways, and review of preclinical data for clinical implications, and other relevant activities
- Translational Medicine (late-stage clinical projects):
In collaboration with Translational Medicine Therapeutic Area Head:
• Responsible for implementation of studies during the Proof of Concept phase by providing medical and scientific leadership and expertise to all line functions on the project team This may include methodology studies to identify and validate novel endpoints for early decision making in Proof of Concept studies
• Drives analysis of studies and presents results to relevant decision boards
• Communicate clinical team matters to Global Project Teams and relevant Novartis Institutes for BioMedical Research and Global Drug Development boards (and other Novartis Boards as required)
• Evaluate clinical centers and foster communication with crucial collaborating investigators, regulatory authorities, and other stakeholders Provide support for dose selection, design and other clinical pharmacology matters throughout the development cycle
• Responsible for content and authoring of documents needed for submission documents with Translational Medicine input (CO, SCE, SCS, SCP, SBP) of NDAs, sNDAs, MAAs, BLAs from regulatory submission through drug registration (including advisory committee and scientific advice group meetings)
- Accountable for compound and disease related biomarker strategies; works closely with Biomarker Expert in implementation
- Develop and implement study protocols for different types of clinical studies (First in Human, Proof of Concept, mechanistic and safety studies)
- Responsible for clinical monitoring and integrated safety data review during and after the live phase of a study
- Provide medical and scientific leadership and expertise to all line functions on the study team
• Lead study-specific teams/ clinical trial teams
• Lead TM clinical teams
• Lead NIBR-sub-team(s) on Global Project Teams for late-phase programs
• Represent Translational Medicine on global development teams
- Represent clinical Translational Medicine aspects to Health Authorities and other stakeholders (e.g. payers, patient advocacy groups)
- Oversee publication and external presentation of study results
- Innovation: Champion and drive new clinical compound characterization opportunities and profiling approaches
- Contribute to initiatives that drive innovation, quality, and efficiency across Translational Medicine
Key Performance Indicators
- Delivery of proposed Development Candidate and Proof of Concept Plan Approval milestones, and Proof of Concept results, according to defined timelines
- Delivery of Clinical pharmacology and profiling strategy including execution of studies according to timelines to support regulatory submissions and approvals
- Team leadership skills that create high performing teams and drive efficient conduct of innovative, interpretable clinical results. Strong adherence to and modeling of Novartis values and behaviors.
- Quality of contribution to disease area strategy discussions and contribution to Clinical Pharmacology plans / Profiling strategy discussions and external collaborations
Minimum requirements
• Medical Degree and additional PhD / post-doctoral equivalent immunology research
• Specialized further training (board certification) and / or clinical research experience in dermatology and/or immunology preferred
• Advanced / business-level / fluent English (oral and written)
• Recognized for medical expertise: demonstrated excellence and clinical / patient expertise in dermatology and / or immunology
• At least 5 years’ experience in a pharmaceutical/biotech company managing/leading early phase clinical trials; or a senior role within a CRO responsible for leading the medical relationship with Sponsors; or experience from a relevant academic medical center with PI or co-PI clinical trial experience
• Relevant international research publication record and a recognized specialist / expert in your field. Respected by colleagues internally and externally, you’ve made significant contributions to your field and created / established new concepts
• Used to working independently and within teams including scientists and non-scientists on study planning and execution, demonstrating competence in a broad range of project and more strategic planning skills
• Demonstrated passion for science
• Excellent written and oral communication/presentation skills, used to distilling and effectively conveying significant messages to different audiences
• Innovation: a curious mind and a natural instinct to seek out new clinical discovery opportunities and clinical study approaches
WHY CONSIDER NOVARTIS?
750 million. That’s how many lives our products touch. 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 empowered to ask new questions, make bolder decisions and take smarter risks.
We are Novartis. Join us and help us reimagine medicine.DivisionNIBRBusiness UnitTranslational MedicineLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegular
