The opportunity
The China Clinical Development Lead is responsible for managing and supporting the development and execution of several global clinical programs in China in accordance to the Chinese environment and market. The incumbent will be working in cross-functional teams in a matrix environment. The individual is expected to be able to function independently in the daily management of clinical research projects including the preparation/review of related key documents (i.e. protocols, Investigator’s Brochures, clinical study reports, summaries for regulatory submissions). The Director is responsible for implementation of the clinical development plan in China and will provide leadership for the Chinese related aspects of asset strategy, working closely with other functional areas (both locally and globally) such as Early and Late clinical development, China Program Leader, commercial, regulatory, pharmacovigilance, CMC, and pre-clinical development in this regard with a particular emphasis on alignment with Chinese regulatory requirements and market strategies. The Clinical Development lead will ensure that the teams are equipped to address the unique challenges and opportunities presented by the Chinese healthcare landscape. The incumbent will be a key contributor to and responsible for the clinical leadership of local regulatory filings. The Director will foster relationships with opinion leaders in assigned Therapeutic area with a focus on building a strong network within the Chinese medical community.
How you’ll spend your day
Will be a member of the Global Program Team, Will have and maintain the expertise necessary for the clinical development of the product
Manages multiple Clinical Development Plans, works with the cross-functional clinical development team, Accountable for the respective clinical trials
Supports Global Clinical Operations in clinical trial initiation, resource planning, study implementation and successful completion, Makes presentations at the Investigator Meetings and other relevant internal or external Venues
Works with Clinical Supplies Group to ensure clinical drug supply plans and timely procurement with the clinical supplies group
Ensures clinical trials comply with clinical guidance, ICH, GCP, in agreement with the laws of the relevant countries and Teva Standard Operating Procedures
Resolves safety or relevant clinical issues in consultation with Global Drug Safety and Pharmacovigilance, VP Clinical Research and the Head of the Global Respiratory Therapeutic Area as needed, Oversees the preparation of regulatory documents from a clinical point of view
Partners cross-functionally with local and global departments such as Regulatory Affairs, Clinical, Medical, Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing, Accounting/Finance, GCO, and GCPR in the execution of Clinical Development Plans
Capable of analyzing and interpreting clinical results and provide a guidance to prepare high quality reports working with Medical Writing
Provides input and direction to the review and finalization of Protocols, Clinical Study Reports and other relevant clinical documents
Author and/or review abstracts, posters and manuscripts, present data at scientific meetings, as needed
Represent Teva at Scientific meetings, advisory boards, KOL boards and meetings with regulatory agencies, as needed
Provides clinical leadership and expertise in meetings with Health Authorities.
Ability to interpret the significance of preclinical and clinical data and to anticipate the information that will be needed to satisfy regulatory requirements
Able to secure, manage and maintain critical partnerships with key business partners; Ability to interface professionally with a wide spectrum of internal and external academicians, agencies and industry executives in the scientific/medical arena
To form collaborations with key external experts to take world class science and deliver meaningful benefits for patients
Any other task assigned by a supervisor
