Job Description Develop HGR Strategic: Develop and offer strategic direction to clinical science and operations teams to optimize drug development processes, ensuring effective management between human genetic resource and study timeline.  Enhance HGR Processes for Efficient Start-Up: Collaborate with internal cross-functional stakeholders to develop and optimize HGR-related processes, ensuring compliance and enabling smooth integration within the broader clinical trial startup activities.  [KL1]   ​ Collaborate on Strategic Planning: Work with clinical operations leadership and relevant departments to formulate comprehensive strategic and operational plans for clinical trials, guiding specialists in developing and executing specific startup plans.  ​​ Leverage Data for Strategy: Lead specialists in analyzing industry data to develop strategies that optimize HGR management within study start-up, ensuring efficient and compliant clinical trial initiation.  ​ Facilitate Cross-Functional Communication: Organize cross-departmental meetings to foster communication and collaboration among team members, promoting the establishment and implementation of standardized processes.  ​ Oversee Project Progress and Quality: Regularly review project progress and quality, guiding specialists in identifying issues and issuing risk warnings to ensure timely advancement.  ​ Develop and Guide Risk Mitigation Plans: Create risk mitigation strategies and instruct specialists in their execution to ensure stability in human genetic resource management and clinical trial operations.  ​​ Ensure Regulatory Compliance: Proactively track regulatory requirements and updates, coordinating cross-departmental resources to align HGR applications with global standards, thereby enhancing the efficiency of study start-up processes.  ​ People Management and Development: Manage resource allocation and talent acquisition, ensuring effective onboarding and continuous growth.

Conduct training and knowledge-sharing to enhance team expertise and optimize performance.

[KL2]   ​​ External intelligence: Develop and build relationships with HGRAC officers and serve as Abb Vie primary POC with HGRAC.

Responsible for gaining industry good practice and taking back to Abb Vie.

On behalf of Abb Vie China, to join relevant external meetings and voice out for Abb Vie.    [ Qualifications Bachelor's Degree or Higher: A bachelor's degree in life sciences, medicine, pharmacy, biochemistry, or related fields is required.

Advanced degrees, such as a master's or Ph.

D.

in clinical research, public health, or health administration, are preferred.  ​Clinical Research Experience: A minimum of 2 years of relevant experience in clinical trial management or clinical research coordination is essential.

Experience in clinical trials at pharmaceutical companies, biotechnology firms, or contract research organizations (CROs) is advantageous.  ​HGR Management or Implementation Experience: Demonstrated experience in managing or implementing human genetic resources processes is essential.  ​Cross-Functional Collaboration Experience: Proven experience in cross-functional communication and coordination, working effectively across multiple departments.  ​Project Management Experience: Strong project management skills, including the ability to develop and execute project plans, ensuring timely completion within budget.  ​Regulatory and Guideline Knowledge: Thorough understanding of clinical trial regulations and guidelines, including the International Council for Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines.  ​Leadership and Communication Skills: Strong leadership and communication skills to manage teams and engage with various stakeholders effectively.  ​Analytical and Problem-Solving Skills: High-level analytical and problem-solving abilities to effectively address challenges that arise during clinical trials.​  Additional Information Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is Abb Vie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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