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Director, Clinical Operation

Director, Clinical Operation

Description:
Description:
Information

Director, Clinical Operation
Department :  CD&RA
Working Place :  US
Recruitment :  1
Nature Of Work :  Full-Time
Working Years Of :  >8 Years
Minimum Academic :  Bachelor
Release Time :  16 Oct, 2019


Job Responsibilities
Clinical operational leader who drives and leads the successful execution of all operational components of global or US clinical program using strong project management, leadership and organizational skills. Excellent communication skills required;
Accountable for operational execution across approximately 3-5 clinical trials and addresses and manages risks and issues;
Contributes to the development of clinical operational strategy and shapes the clinical development plan;
Develops operational plan aligned with scientific mechanisms and objectives for early assets;
Drives the development of program level documents and plans and effectively leads a large global team of individuals assigned to the program;
Partner with other functional areas for the successful implementation and execution of clinical studies;
Provide scientific expertise for selection of investigator and vendors;
Develop budget plan and track the status of clinical projects;
Manage vendors to ensure the quality and timing of clinical trials;
Support project budget planning and management;
Train internal colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol.


Minimum Requirements
A minimum of a BA or BS Degree with significant scientific research experience required;
Minimum of 8-10 years of experience drug development experience within other biotech / pharmaceutical companies are required;
Prior industry Oncology Drug Development experience a plus, specifically experience in conducting phase I/II clinical trial and deep understanding of relevant regulatory health authority expectations and regulations;
Ability to multi-task and work in a fast-paced environment;
Excellent written and oral communication skills;
Knowledge of GCP and ICH guidelines;
Flexibility to work with colleagues in multiple geographic locations;
Strong leadership competencies and influencing skills with senior leaders and cross functional leaders;
Experience with the development and support of related SOPs and policies is expected;
Broad clinical operational experience and strong project management skills.

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