Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
1. Supports the TA Head and Global TA Science Lead, proposes development strategies and clinical pathways for new compound registrations in China.
2. Acts as China Local Clinical Leader to lead evidence generation working group for excellent delivery for trials in China and to assess new trial opportunities. Provides scientific expertise in prioritizing diseases and compounds for China, including opportunities for alliances and partnerships. Provides China scientific inputs to the global TPP.
3. Provides China clinical expertise to design clinical development plans and protocol discussion, ensuring the study design meeting the local regulatory requirements, aiming for efficient development tactics for registration.
4. Initiates proper Development-led medical activities, i.e. medical surveys, Ad Board meetings, KOL visits and other insights development, to support clinical development plan formation and execution.
5. Works closely with Regulatory Affairs to develop efficient pathway for registration with scientific justification, generating and reviewing China regulatory filing materials, based on clinical expertise from CTA through NDA approval.
6. Establishes scientific partnership with Chinese academia and key study centers for effective planning and high-quality implementation in China.
7. Provides medical/scientific training on program specific standards to CDO and investigators to ensure consistency through the process of design, conduct and reporting of clinical trials.
8. Provides local medical support to Global study team, including trial medical monitoring, responding to protocol-specific site questions, resolving data queries, and performing analysis to address questions on efficacy and safety etc.
9. Ensures seamless communication and handover to medical affairs of approved indications and support launch activities.
10. Ensures all activities are in compliance with all applicable national laws and regulations, guidelines, codes of conduct, AbbVie's policies, procedures and accepted standards of best practice.
Qualifications
IDEAL CANDIDATE:
1. • Medical Degree or Bachelor’s degree. With strong medical background and clinical practice experience of related TA area (psychiatry or neurology), adequate knowledge of the drug development process and the regulatory framework for clinical development. Working experiences (> 4 years) in medical and clinical development group of pharmaceutical (or biopharmaceutical) company or equivalent clinical practice is essential.
2. Clear understanding of the developmental program interplay among Regulatory Affairs, Clinical Development and Commercial objectives. Experienced in leading multiple, diverse clinical development programs is plus.
3. Strong insights to study design, good knowledge of data collection, management, analysis, and interpretation are required.
4. Strong verbal and written communication skills are required to complement the ability to analyze and summarize scientific/clinical data, and develop recommendations that affect the conduct of trial and the content of regulatory documents.
5. Effective collaboration with peers, stakeholders and partners to achieve positive impact to development results.
6. High customer orientation and patients-centric thinking.
7. Strong commitment to be compliant with all the relevant rules and procedures, and to scientific quality and integrity.
8. Fluent spoken English and solid written English skills.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
