Study Director
Employment Type : Full-Time
Overview:Who is WuXi AppTec?WuXi AppTec is a contract research organization (CRO) and global leader in supporting the pharmaceutical, biotechnology, and medical device industries. Our St. Paul, Minnesota site is a rapidly growing global leader in the medical device (ranging from simple tongue depressors and adhesive bandages to complex programmable pacemakers) and combination product testing industries, focusing on nonclinical testing that includes biocompatibility, safety toxicology, and analytical chemistry. Our teams support some of the most innovative medical devices and combination products created by leading medical device manufacturers both locally and globally. Our Test Facility plays a vital role in understanding the unique interface between biomedical engineering and the biology of living things. As an innovative-driven, customer-focused organization, WuXi AppTec’s open-access platform enables global collaboration from over 30 countries to improve the health and/or treatment of patients in need, and to realize WuXi AppTec’s vision that “every drug can be made and every disease can be treated.” For more information please go to http://us.wuxiapptec.com/.
WuXi AppTec Offers:
Medical, Dental, and Eyecare Coverage - Health Savings Account + Employer Contribution - Flexible Spending Account - 401(k) Savings Plan + Employer Match - Employer Paid Basic Term Life and AD&D Coverage - Employer Paid Long Term Disability Insurance - Short Term Available with Employer Contribution - Generous Personal Time Off Plan (PTO) + 10 Holidays Per Year
If this information intrigues you or it sounds like a place you would like to start/further your career, WuXi AppTec would like to talk to you!
Department Description:The Study Operations department is the center point of control for all studies conducted within the facility. Study operations serves as the interface between the St. Paul facility, Subcontract Laboratories and the Sponsor in terms of study planning, organization, execution, data analysis and final report construction. Tasks executed within the department can be placed into the following three categories in most cases.
- Pre-study phase that include but is not limited to study protocol and worksheets development, IACUC protocol development, client communication, scheduling the study.
- In-Life phase involving providing support to laboratory staff as necessary, troubleshooting and client communication of unexpected or unusual observations, and leading or being involved in investigations observed during the study and study impact such as deviations or laboratory investigations.
- Reporting phase involving study data review, recognizing and initiating any deviations from the protocol and Standard Operating Procedures, drafting and finalization final report, and engaging with Quality Assurance during report review process as required.
Job Summary: Responsible for all aspects of custom studies performed within In-Life Services (ILS) at WuXi AppTec. The Study Director – Customs interfaces between the St. Paul facility, Subcontract Laboratories and the Sponsor in terms of study planning, organization, execution, data analysis and final report construction. They will handle all resource planning and sponsor communication to complete the assigned studies on timeResponsibilities:- Responsible for all aspects of assigned custom projects
- Maintains up-to-date knowledge of applicable guidelines and regulations
- Performs data analysis, data interpretation and reporting of results
- Ensures all aspects of the study are compliant with appropriate SOPs, GLPs, and applicable regulatory guidelines
- Interacts with Verbal & Written communication with internal and external clients
- Consult, advise on complex non-clinical or research/discovery experimental designs
- Generate and maintain client and IACUC protocols
- In charge of study initiation and closure
- Manage and monitor multiple customized projects simultaneously
- Frequently interact with technical staff to ensure study validity and protocol compliance
- Develop expertise in applicable guidance interpretation
- Identify and implement process improvements and best practices
- Contributes scientific and technical expertise with high attention to detail
- Demonstrates efficient and organized project management skills, effective communication skills, strategic and critical thinking as well as problem solving abilities
- Thrives in a fast paced, multitasking environment, showing both leadership and team building skills
- Ability to work in a team environment and independently as required
- Contributes to the overall operations and to the achievement of departmental goals
- Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
- Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
- Other duties as assigned
- May be required to assist in other departments
Qualifications:Experience / Education- Minimum 5 years of relevant experience or equivalent
- PhD or MSc in toxicology, pharmacology, microbiology, biological sciences, or related field. Experience may be substituted for education (e.g., Bachelor’s in biological sciences plus 5 or more years of relevant experience)
- Preferred (Ex. AALAC certifications, SPHR)
Knowledge / Skills / Abilities:- Proficient in Oral & Written communication skills
- Need to be able to read, write and understand English
- Strong Customer Services Skills
- Experience with Statistical analyses
- Experience with small animal studies
- Knowledge of medical device and/or biologics testing requirements, preferable
- Experience with GLP, preferable
- Experience in a regulatory environment, preferable
- Experience in technical writing or formal data presentation, preferable
- Proficient in Microsoft (Excel, Word, Outlook)
Physical Requirements:
- Must not have animal allergies to applicable species in this facility
- Must be able to work in environment with variable noise levels
- Ability to stand /sit/walk for long periods of time
- Ability to lift 25 lbs routinely
- Ability to crouch, bend, twist, and reach
- Ability to push/pull 25 lbs routinely/ often / occasionally
- Clarity of vision
- Ability to identify and distinguish colors
- Must be able to perform activities with repetitive motions
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.