Imagine being involved in innovation and projects that change the course of our industry on a daily basis!  At Labcorp, one of the world?s largest and most comprehensive pharmaceutical solutions service companies, you will have an opportunity to build an exciting career while you make a direct impact on the lives of millions.

We have an excellent career opportunity for a Study Director III - Toxicology, Cell and Gene Therapy to join our team in Madison, WI.

Embrace possibilities and change lives while growing your career.

Position Summary

Serves as a Study Director, Principal Investigator, or Contributing Scientist for nonclinical toxicology studies, as described in the GLPs.  Represents the single point of control for safety assessment studies and being legally responsible for the study. Learns overall responsibility for the technical conduct of a study as well as for the interpretation, analysis, documentation, reporting of results, and archival in compliance with appropriate policies, SOPs, GLPs, Home Office License requirements (if applicable), and regulatory agency guidelines. The Study Director is the main client contact and advisor for ongoing studies and must develop a full understanding of the Sponsor?s requirements.

Candidates given best consideration will have the following qualifications:

• Strong client relationship building and management skills

• Excellent organizational and time management skills

• Toxicology and/or Cell Therapy, Gene Therapy, Genetics, Virology backgrounds

• Excellent verbal and written communication skills

• Ability to help foster a high professional standard and encourage good staff relationships

• Ability to understand financial status of ongoing studies

Education/Experience

• PhD in toxicology, regenerative biology, genetics, virology, immunology or related subject, DVM, or equivalent degree is preferred. BSc or equivalent or MSc required. Experience may be substituted for education.

• Experience in regenerative or immune cell and/or viral or non-viral gene therapeutic development or academic research is highly desirable

• Previous experience in a contract research organization, as a Study Director or Principal Investigator is preferred

• Experience in directly overseeing or acting as a team member in pharmaceutical non-clinical drug development is highly desirable.

Essential Duties:

• Works with management, mentors, key trainers, experienced Study Directors, and relevant support teams, as appropriate, to obtain and drive training.  

• Develops Protocols and ensures that the Protocol, including any changes, is approved and in compliance with appropriate policies, SOPs, GLPs, guides/work instructions, and regulatory agency guidelines. 

• Ensures that test and control materials are available, have been suitably tested for use on study (identity, purity, etc.), and that appropriate technical and safety data are obtained.  

• Monitors progress and status of assigned studies and research projects. Ensures all experimental data, including observations of unanticipated responses to the test system, are accurately recorded and verified.  

• Communicates regularly with the Sponsor, providing study progress updates and participates and hosts sponsor visits. 

• Directs analysis of data, preparation of reports, and ensures compliance with Protocol and regulatory requirements is documented within the report. Addresses and approves responses to quality assurance inspections for GLP-regulated studies. Prepares report amendments when needed. 

• Leads the scientific interpretation and integration of study data; consults with the relevant scientific stakeholders, Principal Investigators, and Contributing Scientists; and ensures all data are accurately interpreted and support the overall toxicological conclusions. 

• Ensures appropriate/timely archival of study data, specimens, and the report. 

• Participates in regulatory visits, as appropriate. 

• Command of working in matrixed reporting environment.  

• May author publications and presentations for submission to peer-reviewed journals or scientific meetings. 

Benefits: All job offers will be based on a candidate?s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Commissions, and Company bonus where applicable.  For more detailed information, please click here. 

Why People choose to work at Labcorp: 
At Labcorp, it?s our people that make us great - it?s what our clients, our partners and, most importantly, what our employees say. Here, you?ll have the opportunity to work with extraordinary people with diverse viewpoints. You?ll discover your own outstanding potential as we build an even stronger organization with industry leaders from early development to the clinic and beyond.  We help our clients develop medicines that improve health and improve lives of their family and friends.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

We encourage all to apply

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About Labcorp

Clear and confident health care decisions begin with questions. At Labcorp, we’re constantly in pursuit of answers. With unparalleled diagnostics and drug development capabilities, we accelerate innovation and provide insight to improve health and improve lives. Whether you’re a patient, provider, researcher or in the pharmaceutical industry, we’re here for you. More than 70,000 employees strong, we serve clients in more than 100 countries. Labcorp (NYSE: LH) reported revenue of $14 billion in FY 2020.

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