Translational Project Leader

China, Shanghai, Shanghai

Team Leadership

- Ensures that the overall vision/strategy for the project incorporates strategic options in alignment with Disease Area Strategy, time, cost and risk and addresses technical, regulatory, business and operational needs

- Develops and delivers clear communications of program strategy, progress and needs across the organization, articulating messages clearly and concisely adapted to the objectives and needs of the audience (verbal and written)

- Leads, motivates and organizes the program team to execute a cutting-edge project strategy in accordance with its goals and budget from CCS (entry into GLP tox) to readiness for phase III, assuring deliverables are met for clear decision making and project transition to lifecycle

- Ensures the optimal blend of team members so that the team is functional from an expertise and interpersonal perspective; adjusts team composition dynamically as merited by the project needs

- Sets challenging team goals and ensures that best practices are used to attain these goals with a sense of urgency, strong can-do attitude, and best possible performance

- Creates a positive team environment that instills trust and ensures clear transparent communications and gets the team behind the overall goal/vision for the project

- Provides input to team member performance, including sub-teams

- Leads team to develop scenarios including alternative development options (cost, time, risk/benefit) for strategic decision making

- Builds on others in their area of expertise

- Leads co-development projects – balancing the needs of Roche and partners in collaborations

- Owns the TPP (Target Product Profile), coordinates the CDP (Clinical Development Plan), Heatmaps, Discovery and Translational Plan (DTP), and valuation within the team

- Lives and demonstrates pRED guiding principles

- Develops criteria for transition to late stage development in collaboration with other pRED and Roche functions and is accountable for its delivery.

- Defines translational medicine and biomarker strategy and delivers activities with subteam and key medical interfaces in Pharma Development, including Regulatory & Biostatistics. 

- Owns the exploratory CDP (e-CDP) for first-in-man (EIH), proof of mechanism (PoM) and proof of concept (PoC) studies and phase 2 LIP enabling studies.

- Is accountable for Phase III-enabling activities, protocol synopses, study protocols, clinical study reports (CSRs) and related regulatory documents as well as overall design and the clinical and scientific content of experimental medicine

- Supports identification, assessment and internalization of external opportunities for the I3 DTA in collaboration with partnering and pRED functions

- Propose, establish and lead external collaborations to address strategic and tactical needs of DTA.

- Works in close collaboration with I&I scientists and pRED functions to identify, select and validate targets of high relevance for I&I 

- Develops translational discovery plan for new targets at entry into portfolio

 

Communications

- Communications are compelling and impactful, tailored appropriately to the audience

- Encourages creative and/or unconventional ideas and ensures that these are exploited by the team, as appropriate

- Challenges team members and status quo constructively to lead delivery of ambitious milestones

- Leads team to create and document an integrated Discovery and Translational Plan and secures agreement on transition plan for life cycle transition of project

- Presents development options, strategies and recommendations to governance boards (DTA, eSPC, LSPC, and others) for endorsement at key decision points to allow fact based, transparent and informed decision making

- Serves as the interface between the DTA and partner functions on project-related issues; builds effective cross-functional working relationships

- Serves as the primary contact with partners in co-development collaborations

Resource and Budget Management

- Interacts with designated contact persons in Roche’s supporting departments of finance, project management, regulatory, clinical operations, etc. (“functions”) to ensure that appropriate resources are allocated at the appropriate time and aligned with agreed plan

- Works with functions to identify gaps and to find collaborative solutions

- Resolves inter-project resource conflicts to avoid resource bottlenecks

- Takes accountability for project budget and milestones

Risk Management:

- Leads the team to identify and manage key risks to the project

Leads the team to develop and implement innovative and feasible de-risking strategies