Scientist IV, Drug Metabolism and Pharmacokinetics Full-time

Scientist IV

Boehringer Ingelheim is seeking an enthusiastic, creative, and highly motivated Scientist IV to join the US Bioanalytical Sciences group in the Drug Metabolism & Pharmacokinetics (DMPK) department at our US headquarters in Ridgefield, CT.

The main responsibilities of the Scientist IV include the logistical coordination and management of outsourced work packages including contracting, monitoring, data transfer and reporting, all related to clinical trial and nonclinical sample bioanalysis. Additionally, this role is responsible for the scientific monitoring and outsourcing of clinical and nonclinical bioanalytical studies, serving as the primary key contact and liaison between DMPK, clinical trial teams, Nonclinical Safety, and bioanalytical CROs.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

Duties & Responsibilities

• Serve as the primary key contact and liaison between DMPK, clinical trial teams, Nonclinical Safety, and bioanalytical CROs, ensuring timely and effective communication of clinical trial and nonclinical study information
• Logistical management of outsourced clinical and nonclinical sample analysis work packages including contracting, PO generation, invoice reconciliation, spend tracking, and budget management
• Build and maintain CRO outsourcing relationships for successful and productive partnerships
• Initiates, designs, interprets accurately, troubleshoots and completes routine procedures independently and efficiently; initiates, designs, interprets accurately, troubleshoots and completes non-routine and difficult procedures generally without supervision; Conducts exploratory experiments
• Proposes, gains support for and implements ideas from individual´s knowledge of science and technology and understanding of drug discovery process
• Proposes, evaluates and implements new technologies; independently applies basic scientific principles, performs literature searches, attends scientific meetings, and keeps abreast of literature in own field
• Effectively communicates and defends own work, orally and in writing, in the context of the team goals at meetings
• Demonstrates a solid level of technical proficiency in field; trains technicians and junior level scientists in this field
• Reports and treats data with a high level of integrity and ethics
• Complies with applicable regulations, performing all work in a safe manner; Maintains proper records in accordance with SOPs and policies
• Collaborate with key clinical and nonclinical stakeholders (e.g. Experimental Medicine, BDS, CBOs, Clinical Operations, NCS Study Directors, and DMPK leads) for protocol development and review, sample handing, sample analysis plans, data transfers, milestones, report timelines, accurate budgeting, and other clinical/nonclinical requirements
• Conduct CRO monitoring of outsourced work packages in support of clinical trials and nonclinical studies, ensuring critical issues are communicated to DMPK leads in a timely manner
• Function as a team member and display the behaviors and attributes required to complete cross-functional work within a highly dynamic, global work environment

Requirements

• Master´s Degree with 6+ years experience in a related scientific discipline; or Bachelor´s Degree with 10+ years experience in Cell Biology, Biochemistry, Chemistry, Pharmaceutical Sciences; or equivalent experience in a related field
• Perform scientific, logistical, and operational oversight of outsourced clinical and nonclinical bioanalysis, including contracting, monitoring, data transfer, reporting, and team communication of sample analyses
• Excellent oral and written communication skills
• Simultaneous management of diverse projects in a global environment; ability to be a team player in a matrix cross functional environment
• Monitor study timelines and effectively communicate information across multiple disciplines
• Advanced training in the area of technical expertise
• Database management expertise
• Propose new experimental designs and conduct probing experiments
• Provide training and guidance to laboratory personnel
• Prepare technical reports, publications and oral presentations
• Act as a leader in absence of supervisor
• Appropriate level of understanding of applicable regulation

Desired Skills, Experience and Abilities

• Method development of PK and/or Immunogenicity bioanalytical immunoassays (cell based and/or ligand binding) and/or LC-MS/MS PK methods for biological therapeutics
• Scientific monitoring of method transfer, troubleshooting, validation, and sample analysis of both nonclinical and clinical PK, ADA, and nAb methods
• Project management (internally and/or with external partners).