TRANSCENTA HOLDING - A Global Fully Integrated Biotherapeutics Company

Transcenta, Biologics, Antibody, Claudin 18.2

TRANSCENTA HOLDING - A Global Fully Integrated Biotherapeutics Company

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Vice President, Clinical Operations - US

Vice President, Clinical Operations - US

Global R&D
Working place :  US
Recruitment :  1
Nature of work :  full-time
Working years of :  10+
Minimum academic :  Master
Release time :  07 Jan, 2023
Job Responsibilities
  • The VP of ClinOps in US assumes the global trial team leader of the late phase trials in Transcenta, accountable for the late phase trials delivery and relevant global trial team management. In addition, this role is also accountable for the overall people and performance management of US and EU clinical operation team.

  • The VP of ClinOps - US is responsible for providing advice, guidance, and support to assigned staff and allocates resources to the projects/trials as appropriate to assist with their implementation and to ensure compliance with regulatory requirement, Good Clinical Practice (GCP) and Transcenta Standard Operating Procedures (SOPs).

  • The VP of ClinOps - US is accountable for contributing to strategic planning related to project management, as well as overall management of projects to achieve defined targets and milestones.

Requirements
  • Background:

  • Medical, pharmacy, or bioscience education background.

  • Excellent working knowledge of current ICH-GCP, ethical and regulatory requirements.

  • Comprehensive knowledge of clinical trial processes desirable.

  • High level of competency and a minimum of 15 years’ experience in clinical research within a pharmaceutical company or CRO practical experience. Should fall within a broad range of studies from early phase to late phase.

  • Proven project management experience in multinational clinical trials within a pharmaceutical company or CRO.

  • Proven management experience of at least 10 years either as a line manager or project team manager.

  • General:

  • Excellent interpersonal skills, presentation skills and team leadership ability.

  • Excellent interpersonal skills and the ability to work well and flexibly i.e. autonomously, in small teams and with a wide range of varying stakeholders.

  • Ability to see the big picture, yet still focus on detail.

  • Ability to be flexible and adaptable in the face of changing organizational priorities and ambiguous environments.

  • Strong focus on quality of work.