KP Recruiting Group is a consulting firm that providesleadership and exceptional talent to some of the world’s leading companies.Headquartered in the Midwest, KP Recruiting Group has successfully completedcountless engagements in the United States, Europe and Latin America. Werepresent clients in all industries and all sizes. Our mission is to provideexceptional client and candidate experiences in order to get the best possibleresults. On behalf of our client, we are excited to present the following confidentialrole. We look forward to hearing from you and discussing the opportunity!

The Role:

The Bioanalytical Sciences group directs CROs in the development and validation of bioanalytical methods to measure drug concentrations and immunogenicity in all nonclinical and clinical studies across the entire pipeline of small molecules and biologics.

Key Responsibilities:

• Direct and manage the activities of US staff within Bioanalytical Sciences
• Plan/oversee budgets and resources within the US Bioanalytical Sciences group to ensure alignment with project and corporate goals and objectives
• As a member of the global Bioanalytical Sciences Leadership Team, contribute to the strategic and scientific direction of the Bioanalytical Sciences group across all sites
• Attract and retain key talent to build and maintain bioanalytical capabilities 
• Drive alignment with project teams, functional leadership, and governance committees on bioanalytical strategies and resourcing for small molecule and biologic programs
• Serve as the bioanalytical subject-matter expert on cross-functional drug discovery and development project teams
• Provide oversight of bioanalytical CROs to facilitate the transfer, development, and validation of regulated (GLP/GCP) bioanalytical methods and ensure quality data and reports are delivered within specified timelines
• Manage CRO contracts and bioanalytical aspects of project budgets

Requirements

• A minimum of 10 years of experience in the pharmaceutical industry supporting bioanalysis in non-clinical and clinical studies

• Extensive experience developing and validating bioanalytical and immunogenicity methods for small molecules and biologic therapies
• Experience preparing bioanalytical sections of regulatory submission documents (e.g., IND, NDA/BLA) and bioanalytical components of nonclinical and clinical study protocols

• Strong knowledge in GLP/GCP regulations and regulatory guidance documents that apply to bioanalysis

• Excellent written and oral communication skills
• Excellent leadership skills

• Demonstrated ability to effectively influence without authority in a matrix organization
• Proven ability to prioritize and deploy resources appropriately to align with project and corporate objectives

Required/Preferred Education and Licenses

• Doctorate degree in chemistry, analytical sciences, pharmaceutical sciences, or a related field

Benefits

Ourclient offers a comprehensive benefits package including:

401kMatching

Family andIndividual Insurance Packages (Health, Life, Dental, and Vision)

Paid TimeOff & Paid Holidays

Long &Short-Term Disability

IdentityTheft Plans

Retirement& Pension Plans

EmployeeAssistance Program

EmployeeReferral Program

TuitionReimbursement Programs

Advancement& Professional Growth opportunities 

ParentalLeave

& More