JOB DESCRIPTION

 

JOB FUNCTION:     Clinical Supply, Associate Director   

GRADE/TITLE:         Associate Director or Senior Manger   

EMPLOYER:             Brii Biosciences  

DEPARTMENT:        Clinical Development

JOB LOCATION:      Beijing, China  

REPORTS TO:          Head of Clinical Operation & Innovation

EFFECTIVE DATE:    30-July-2019

SUMMARY: Ensure the best set-up, execution and closure of the supply and distribution of Investigational Medicinal Products (IMP's) and other clinical trial materials in the frame of Brii Biosciences global clinical trials, to optimize the performance both on a cost and on a supply basis


DUTIES AND RESPONSIBILITIES:

  • Manage the packaging, storage (in case of outsourcing to an external vendor) and the distribution of IMP's with the main objective of avoiding any interruption of supplies to clinical trial patients/subjects (no stock-outs)

  • Achieve a smooth supply operation (100% Customer Service Level) taking into account of applicable international Good Manufacturing Practice (GMP) rules.

  • Bring logistic and GMP expertise related to clinical trial material (CTM) to the clinical trial teams and take responsibility for the supplies and distribution.

  • Optimize CTM supply-related processes by discussing and deciding on roles and responsibilities with the main interfaces complying with the established quality assurance system.

  • Contribute to the optimization of CTS processes and structures. Support the implementation of new processes by training CTS staff and main interfaces outside CTS as appropriate.

  • Manage clinical trials from the supply and distribution point of view, on a global as well as on an operational daily basis

  • Maintain a pragmatic and realistic approach, while striving for worldwide Good Manufacturing Practice (GMP) - compliance (e.g. EMEA, FDA) for clinical trial material and 100% customer service.

  • Discuss and agree together with the involved functions on the bulk demand plan for a project/study to support projected study timelines

  • Represent Clinical Trial Supply in the Clinical Trial Teams

  • Take responsibility for IMP planning,(packaging, in case this activity is outsourced), costs and resources, distribution, tracking and reconciliation, and keep adequate records of all business activities.

  • Agree with the involved functions on a packaging and distribution concept

  • Work with external providers as appropriate (e.g. for Interactive Voice/Web Response Systems) to simulate and optimize the supply and delivery plan

  • Ensure full GMP compliance of the studies for what concerns the supplies, including returns, destruction and reconciliation

  • Contribute ideas to improve the performance and quality of the clinical trial supply process


QUALIFICATIONS:

  • Bachelor’s degree (advanced degree preferred), life sciences preferred or healthcare-related field;

  • 6 years or above (3 years or above for senior manager) of working experiences of clinical supply management in pharmaceutical or biotechnology industry;

  • Project management experience is a plus;

  • Good understanding of global and local regulatory guidelines, GCP, Health authority requirements and clinical development process;

  • Strong interpersonal and communication skills (verbal and written) in Chinese and English;

  • Ability to handle multiple task and to prioritize, strong organizational and presentation skills;

  • Leadership skills, decision-making and problem-solving skills

  • Good cross-functional team leader who fosters team spirit and team motivation (team work)

  • Experience in managing and leading international meetings and ability to work in an international environment with internal and/or external partners (CROs etc.)

  • Established awareness and respect of cultural differences and competent to collaborate with global partners/vendors;


The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.