eNewsletter Signup
Miles
Km80.5

Associate Director/Director, Bioanalytical Sciences

Kolltan Pharmaceuticals, Inc.

E-Mail to a Friend Add to Job Folder View All Jobs Back to Search Results Share
Location: New Haven, CT Posted Date: 4/26/2013 Position Type: Full time Job Code: 2013DirBioanalyticalSci Required Education: Doctorate/PhD Areas of Expertise Desired: Bioanalytical Services

Description

Kolltan Pharmaceuticals, Inc. is a biotechnology company that was formed in 2007 by Dr. Joseph Schlessinger, Chairman of the Department of Pharmacology at Yale School of Medicine.  The company’s current R&D focus is on the identification of novel antibodies and biologics that target receptor tyrosine kinases for oncology and other serious diseases.  The company takes great pride in scientific innovation and has a management team with a proven success record in the biotechnology and pharmaceutical industries. Consequently, the company seeks job candidates with strong scientific credentials and biologics industry experience to join the existing seasoned R&D team of scientists and managers based in New Haven, CT.

Associate Director/Director, Bioanalytical Sciences

Kolltan Pharmaceuticals, Inc. seeks a full-time Associate Director/Director, Bioanalytical Sciences to be part of the Translational Medicine team reporting directly to the Vice President, Translational Medicine. The ideal candidate is an experienced senior scientist with a background that includes being accountable for bioanalytical assays (BAS) in support of nonclinical and clinical programs. Kolltan’s BAS assays will mostly be managed through contracts with external CROs with early assay development, preclinical and some clinical exploratory assay work done in house. The candidate will be a laboratory leader for the department of Translational Medicine, utilizing a scientific approach to support the development of biologics in oncology and non-oncology indications with primary responsibility for the development and management of the evaluation and interpretation of pharmacokinetic, immunogenicity and pharmacodynamics assays. The scientist will need to have a high level of technical expertise in order to provide assistance to internal and external researchers in development and validation of methods and their use in support of nonclinical and clinical research programs. This position offers opportunity for high level impact. The desired starting date for this position is in the third quarter of 2013.

The responsibilities for this position include: (i) lead, implement and manage development and validation of robust methods to quantitatively and qualitatively characterize PK, ADA and pharmacodynamic markers for biotherapeutics (monoclonal antibodies and ADC) internally and through CROs; (ii) lead the development, validation where appropriate, implementation and troubleshooting of assays to measure concentrations of biomarkers in biological matrices including protein and nucleic acids; (iii) design, analyze and interpret biomarker studies; (iv) function as in house expert for bioanalytical assays for clinical studies and advise on design and implementation of nonclinical bioanalytical assays that can seamlessly transition into clinical studies; (v) implement and assure laboratory works under GxP or applicable guidelines as needed (vi) direct development and validation of bioanalytical studies for submission to regulatory filings; (vii) ensure prioritization and allocations of resources to ensure delivery of data from internal and external labs in a timely manner to support project progression.

Requirements

The candidate should hold a Ph.D. degree with training in biochemistry or immunology and have at least 5 years of industry experience. Expertise and training in analytical technologies for development and validation of assays for proteins including monoclonal antibodies in blood and tissue is required. Experience in handling, analyzing and reporting on clinical trial samples is required. Experience in oncology, proteomic, multiplexing and nucleic acid (miRNA, mRNA, DNA) analyses is desired. The ability to work in a matrix environment and establish and manage CRO relationships is essential. Strong communication (written and verbal) as well as the ability to work collaboratively is a must.

E-Mail to a Friend Add to Job Folder



By applying to/saving a job using , you are agreeing to comply with and be subject to the Terms of Use for use of our website. To use our website, you must agree with the Terms of Use and both meet and comply with their provisions.

ADVERTISEMENTS