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Head of Study Director/PM

Covance 10/18/2018 6:18:13 PM
JOB ID: 24559 Category: Other
Shanghai, China



Job Overview

General Purpose and Scope:

* Supervise study director and project management staff, responsible for the technical and scientific supervision and conduct of Mammalian Toxicology studies. Responsible for the day to day operation and performance of the scientific staff within the Toxicology Study Direction and Project Management group. May maintain study director responsibilities for toxicology studies
* Serves as a Project Manager and/or Study Director, as described in the GLPs. Has overall responsibility for the client interactions, working with business development, project management including study designs for regulatory submissions, technical conduct of a study as well as for the interpretation, analysis, documentation, and reporting of results
* Managerial role for talent retention, career development, recruitment and employee performance evaluation
* China Point of Contact in the global safety assessment working groups within Covance

Duties and Responsibilities:

* Supervises the training of study directors/project managers and contributes to the training of other staff members.
* Oversees the scientific aspects of standard operating procedures, protocols and reports to ensure full compliance with regulations.
* Reviews and makes recommendations on research proposals for scientific feasibility and cost benefit perspectives.
* Responsible for the development and implementation of plans, policies and procedures within department guidelines to improve the work quality, efficiency and/or productivity of these groups.
* Work closely with local and global teams as well as the leaders in other sites to ensure testing is completed by established deadlines in compliance with SOPs, GLPs and regulatory agency guidelines.
* Facilitates implementation of new technology to reduce errors and/or improve productivity and quality.
* Initiates, plans and implements staff development programs. Develops department capabilities and resources to meet both present and future needs.
* Monitors progress toward meeting departmental goals and objectives, and takes required corrective action. Works with cross-site management to maintain harmonized processes, goals and objectives for Safety Assessment.
* Provides technical or scientific expertise and guidance in study design and training.
* Responsible for the corrective actions and issues resolution process for issues involving Toxicology Study Direction and Project Management.
* Coordinates efforts of the study team
* Develops protocols and ensures that the protocol, including any changes, is approved and is in compliance with appropriate SOPs, GLPs, and regulatory agency guidelines.
* Reviews cost estimates to ensure that all protocol/amendment driven work scope specifications have been included in the price estimation.
* Understands financial status of ongoing studies.
* Monitors progress and status of assigned studies. Ensures that all experimental data, including observations of unanticipated responses to the test system, are accurately recorded and verified.
* Directs preparation of reports, ensures compliance with protocol and regulatory requirements, and submits them to the client.
* Participates or hosts client visits and pre-study outline preparation.
* Will serve as a mentor to newly hired Study Directors.
* Capable to translate study protocols/reports between English and Chinese
* Performs other related duties as assigned.

Education / Qualifications

* MS or PhD in toxicology or related subject, DVM or equivalent degree. Experience may be substituted for education

* DABT certification preferred but not required


* Five to Ten + years of related Experience in the toxicology and drug development field. Relevant Experience may be substituted for years of related Experience . People management and supervisory Experience will be important aspect of this position
* Must have knowledge of and have worked as a toxicology study director and project management
* Must be able to work in a laboratory setting with laboratory animals.
* Skilled in performing scientific presentations and preparing scientific publications
* People skills

Position Type: Full-Time

Location: Shanghai, CHN - China


Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).