Medical Director - Dermatology Translational Medicine

Updated: 13 days ago
Job Type: FullTime

350 million! That is the estimated number of patients worldwide suffering of atopic dermatitis or psoriasis. Join Novartis to help find the right drugs to transform and improve patient's lives all around the world.

You will provide medical and scientific leadership and expertise in a role that significantly impacts the entire Novartis Dermatology drug development pipeline.

• Drive success of early global programs, develop and implement strategies to achieve clinical Proof of Concept or Proof of Mechanism to enable transition to further development
• Drive success of late global programs when appropriate by developing and implementing strategies that lead to clinical pharmacology, design of mechanistic studies and profiling packages that meet regulatory requirements and support differentiated and competitive drug labeling
• Provide scientific expert assessments and support for in-licensing opportunities, including due diligences

Your responsibilities:
Translational Medicine early clinical projects:
In collaboration with your Translational Medicine Therapeutic Area Head or other Translational Medicine Experts
• Develop high value decision-strategies for the Translational Medicine component of drug development projects from Research to clinical Proof of Concept or Proof of Mechanism in a single or multiple indications, including Parallel Indication Expansion-Proof of Concepts
- Represent TM and lead global project teams through First in Human and Proof of Concept phase to drive strategy that enables development
- In collaboration with research scientists, contribute to the proposal of new targets or indications for existing compounds; 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
- Responsible for implementing 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.
- Responsible for clinical portions of the Integrated Development Plan, including the Clinical Development Plan and Clinical Pharmacology Plan
• Accountable for compound and disease related biomarker strategies, working closely with Biomarker Experts in implementation
• Develop and implement study protocols for different types of clinical studies (First in Human, Proof of Concept, mechanistic and safety studies), and other documents such as investigators brochures.
• 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
• Leadership
- Lead study-specific teams/ clinical trial teams
- Represent TM or lead BR project teams
• Represent clinical Translational Medicine aspects to Health Authorities and other stakeholders (e.g. payers, patient advocacy groups)
• Represent clinical Translational Medicine in reviews of external opportunities
• 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

Translational Medicine late-stage clinical projects:
In collaboration with your Translational Medicine Disease Area Head:
• Drive analysis of studies and present results to relevant decision boards
• Communicate clinical team matters to Global Project Teams, relevant Novartis BioMedical Research and Global 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

Key Performance Indicators:
• Delivery of proposed Development Candidates, Integrated Development Plan Approval and Development transition point milestones, and early clinical study results, according to timelines
• 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

Matrix people responsibility per project: 5-8 cross-functional members from within Translational Medicine plus other line functions per project team

Impact of this role?
• Design and implementation of early Clinical Development Plan and studies according to the Integrated Development Plan / Clinical Development Plan / Clinical Pharmacology Plan enabling efficient and rational decision-making, high probability of fast drug registration, favorable drug label and high competitiveness of compounds
• This role has a key impact on the entire Novartis pipeline, transitioning programs from preclinical through early clinical and ultimately to full development via First in Human, Proof of Concept, and driving the program after Proof of Concept by delivering key Profiling data to support regulatory submissions
• Recognized Expert in field, drives project team clinical strategy. Works globally across Novartis as well as country organizations as appropriate

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