Director, TM Discovery(Physician)/TME II/I

Director, TM Discovery(Physician)/TME II/I
*Novartis supports international family relocation to China

Provide medical and scientific expertise to drive success of global studies and implement strategies to achieve clinical Proof of Concept (PoC).

Major Activities
1. Translational Medicine
• In collaboration with TM Head or more experienced Translational Medicine Expert, develop high value decision-strategies for the Translational Medicine component of drug develop-ment projects through the PoC phase.
• Lead global project teams through PoC phase to drive implementation of the PoC strategy; participate in project teams through program life cycle from NTRC to registration.
• Responsible for clinical portions of the Integrated Development Plan (IDP) through PoC.
• Responsible for implementation of studies during the PoC 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 PoC studies.
• Participates in analysis of studies and presents results to relevant decision boards.
• Acts as medical monitor for one or more global clinical studies.
• Communicate clinical team matters to project teams and relevant Decision Boards (DADB).
• Convene relevant (internal and external) leaders together to consider the proposed ap-proach to PoC.
• Evaluate clinical centers and foster communication with crucial collaborating investigators.
• Oversee publication and external presentation of PoC clinical study results.
2. Accountable for compound related Biomarker strategies; works closely with Biomarker Expert in implementation.
3. In collaboration with research scientists, identify, develop, and implement strategy for preclin-ical support of program-related objectives. This includes assessment of medical need, pro-posal of clinical development pathways, and review of preclinical data for clinical implications, and other relevant activities.
4. Participate in team presentations to health authorities as TM expert.
5. Prepare and implements DA- or project-specific training and educational programs for project team colleagues from TM and other line functions. Mentor TM colleagues on scientific, clinical, and drug development issues.
6. Contribute to initiatives that drive innovation, quality, and efficiency across TM.
7. Leadership -Models the Research and TM culture - Able to work independently on studies; developing independent approach to program strat-egy. - Impact within a Unit, a Disease Area, geography or other divisions - Makes connections and drives solutions for research programs - Leads and delivers within the matrix - Executes on strategic direction - Operational responsibility for quality and compliance within the organization - Internal TM expert for project teams

Key Performance Indicators
1. Delivery of proposed sPoCs and PoC according to the defined timelines.
2. Identification of novel Clinical Discovery opportunities and PoC approaches.
3. Quality of contribution to Disease area strategy discussions and external collaborations.

Job Dimensions
Number of associates: 5-8 cross-functional members from TM and other lines.
Financial responsibility:
Indirect responsibility for study budget
Impact on the organization: - Design and impleme ntation of early Clinical Development Plan enabling efficient and rational decision-making, high probability of fast drug registration, favorable drug label and high competitiveness of compounds. PoC decision point is identified as the most critical step in the novel innovative pathway of Novartis drug development.
- Recognized Expert in field, drives project team clinicalstrategy. Works globally across various Novartis Institutes and Divisions
Education:Doctoral degree, MD strongly preferred
Languages: Fluent English (oral and written).
Experience/Professional requirement:
- At least 5 years’ experience in a pharmaceutical/biotech company, CRO, or academic medical center, or related experience
- Recognized internally for medical expertise
- Significant contributions to a field over time, creates new concepts
- Recognized publications record
- Excellent written and oral communication/presentation skills
- Independence: Able to work independently on study planning and execution, and with supervision on project planning,
- Innovation: Seeks out new clinical discovery opportunities and PoC approaches
- Demonstrated passion for science
- Ability to distil key messages to support their recommendation
Translational Medicine
China Novartis Institutes for BioMedical Research Co., Ltd
Research & Development
Full Time