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Reporting directly to the Head of Biotech Unit (BTU), the position is a member of BTU core leadership team and contributes to the overall BTU strategy and driving its vision and mission. Leveraging deep therapeutic and functional area expertise, the Clinical Operations Lead in Biotech Unit is accountable for the planning, budget, and oversight the execution of clinical studies of BTU assets, through partnering with execution units, that ensures clinical studies’ quality and cost, meets planned timeline.

Roles & Responsibilities:

+ Accountable for driving clinical operations strategy in line with Biotech Unit asset development strategy

+ Within Biotech Unit, make recommendations in clinical operations area and accountable for clinical operations performance

+ Consult with Advisory Committee for relevant topics and incorporate the ideas into strategy and execution if appropriate

+ Accountable for resource planning and allocation and alignment with Execution Unit

+ Create and be accountable for annual budget and resource forecasts, as well as lead to define CST goals for the assets

+ Create and maintain compound level documents such as IB, ICF, DSUR

+ Ensure timely clinical drug supply

+ Oversee and ensure feasibility, study start-up, site management, drug supply and other clinical studies’ activities operating according to GCP and Health Authorities’ requirements

+ Provide guidance to Execution Unit at regional and global level and ensure timely, quality, and efficient study planning and execution of associated clinical programs/studies

+ Conduct regular review meetings with Execution Unit to mentor, support, and ensure all studies are tracking to budget and timeline

+ Report on study status, goals, operational KPIs, and enforce quality KPIs with support from Compliance team

+ Provide guidance to function team in Execution Unit and may provide coach and mentorship to the team members working on the assets when there’s performance concern and for team development purpose

+ Champions a global mindset and approach across Clinical Operations to foster collaboration and consistency across the organization

+ Provide expert knowledge on the execution of clinical trials through deep understanding of ICH/GCP Guidelines and other applicable regulatory requirements

+ Point of escalation for all assets’ related issues and report back to Biotech Unit core team for discussion and alignment

+ Identify and drive process improvement initiatives in collaboration with GCPL team

+ Collaborates with other function leads within Biotech Unit to provide operational perspectives to enable effective and efficient delivery of clinical development goals

+ Understand and monitor assets’ landscape and competitors’ actions and progresses, and translate market intelligence into clinical strategy

+ Manage risks, opportunities, and issues effectively and transparently at strategic, tactical, and operational levels

+ Other duties as assigned

Qualifications/Requirements:

+ Strong project management skills, including ability to work independently, lead multiple projects simultaneously and consistently meet or exceed project deadlines in a fast-paced environment

+ Ability to seek and utilize benchmark data to monitor and champion opportunities to accelerate project timelines without compromising quality

+ Strong working knowledge of ICH Guidelines, Good Clinical Practices, and Regulatory Agency requirements

+ Proven ability to make sound judgement and decisions. Possess the ability to quickly assess problems/situations and provide effective resolution/solution

+ Excellent interpersonal skills and the ability to build and maintain positive work relationships to effectively interface at all levels across the organization

+ Detail-oriented without losing sight of the big picture

+ Ability to travel 20%

Entrepreneurship & creativity:

+ Have the ambition and passion to drive value and impact with a “can-do” attitude, willing to take calculated risk

+ Adopt an open and creative mindset to pilot new concepts and overcome challenges

+ High learning agility

Strategic thinking & decision making:

+ Drive strategic clinical operations within Biotech unit; integrate business case, mitigate risks and manage resources

+ Make operation-level decisions under set thresholds

+ Accountable for decisions even facing uncertainties and for implementation of development strategy

Cross-functional knowledge & expertise:

+ In-depth clinical operations knowledge to drive operational excellence

+ Sufficient experience and ability to work in an environment that requires seamless cross-function collaboration and handling complexity

Critical Leadership Experience:

+ Proven ability to effectively work in a cross-region, cross-function matrix; able to work effectively in diverse cultures, showing aptitude in modifying style

+ Business acumen - understand unmet market needs; provide clear path to win; demonstrated track record in driving innovation through to the global commercialization of assets

+ Strategic and Decisive Leader - leadership skills that demonstrate energy, passion, courage, vision and demonstrated competence in thinking strategically, analytically and innovatively; able to quickly and creatively analyze and provide solutions to complex challenges; proven experience as a successful decisive leader in a strategic multifunctional environment

+ Able to effectively communicate at multiple levels of the organization

+ Strong change management experience and experience with building new teams preferred

Education:

+ Bachelors degree and 12+ years or Masters degree and 8+ years in clinical or drug development in the biotech/pharmaceutical/CRO industry or the relevant clinical research field.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.