Gainesville, Georgia
Nashville, Tennessee
Overland Park, KS
Posted: 02-Feb-25
Location: Madison, Wisconsin
Type: Full-time
Categories:
Internal Number: 253489
Imagine being involved in cutting edge projects that change the course of our industry daily. Labcorp?s work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. 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 I - Discovery Pharmacokinetics to join our team in Madison, WI. If you have a passion for science and enjoy a fast paced, collaborative environment, this is an ideal position for you!
Position Summary:
The Study Director is responsible for managing the design, conduct and reporting of studies to meet scientific, regulatory and client requirements. The Study Director is the single point of study control and has overall responsibility for the scientific, technical and regulatory conduct of studies as well as for the interpretation, documentation and reporting of results. Close and regular liaison with the client is of primary importance.
· Coordinates efforts of the study team.
· Learns to develop protocols and ensures that the protocol, including any changes, is approved and is in compliance with appropriate SOPs, GLPs, and regulatory agency guidelines.
· Ensures that test and control articles are available, have been suitably tested for identity, etc., and that appropriate technical data are obtained. Also ensure that handling precautions are sufficient to ensure operator safety and that this information is given to the operational areas.
· Learns to review 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 in and may host client visits.
Candidates given best consideration will possess the following:
· Strong client relationship building and management skills
· Excellent communication skills
· Strong attention to detail, organization and time management skills
· Ability to help foster a high professional standard and encourage good staff relationships
· PK / In Vivo experience is a plus
Experience/Skills/Knowledge:
· Basic awareness of the drug development process, regulatory requirements and the scientific techniques of standard metabolism studies required.
· Skilled in performing scientific presentations and preparing scientific publications
· Experience of client management and technical expertise in the relevant business line.
· Experience in a feeder role for a study director with skills and competencies in some of the relevant study types.
· Awareness of requirements for working within a GLP, GCP and GMP (as appropriate) environment
· Previous data interpretation and report writing experience
· Working knowledge of software (e.g., MS Word, Excel) and general IT skills
Education:
· Bachelor of Science with industry experience required.
· Master of Science or PhD degree in related subject is preferred.
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here.
Why People choose to work at Labcorp:
At Labcorp, it is our people that make us great - it is what our clients, our partners and, most importantly, what our employees say. Here, you will have the opportunity to collaborate with extraordinary people with diverse viewpoints. You will 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. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
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