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Director - Bioanalytical Sciences

Employer
Adcentrx Therapeutics Inc.
Location
San Diego, CA
Start date
Nov 19, 2021

View more

Discipline
Science/R&D, Bioanalytical Services
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Biotech Beach

We seek a highly talented and motivated Director of Bio-Analytical Science to drive Adcentrx Therapeutics ground-breaking efforts in cancer biotherapeutics drug development. The candidate will join a new team of researchers in San Diego, with the goal of developing novel targeted therapeutics that can make a difference in the life of cancer patients.

The successful candidate will be a results-driven individual with extensive Bio-Analytical science experience and a keen understanding of the drug discovery process. They will work in partnership with our internal team to identify and establish external collaborations to complement Adcentrx's own programs.

The candidate will be part of a cross-functional team in a highly collaborative and dynamic research environment working closely on a shared mission.

Responsibilities:

• Leads Adcentrx Bio-analytical science to support non-clinical and clinical projects, including PK, ADA and biomarker assay development, validation and sample testing for company antibody- based therapeutics.

• Establish bioanalytical capabilities for assessment of drug pharmacokinetic (PK) pharmacodynamic (PD), immunogenicity, biomarkers and characterization of drug mechanism of action

• Lead development, qualification, and validation of PK, ADA and biomarker assays to support non-clinical and clinical studies

• Manage and oversee CRO outsourcing studies

• Lead generation and life cycle management of critical reagents for assays supporting required bio-analytical studies

• Author and review Standard Operating Procedures (SOP), validation and bioanalytical study protocols and reports and contribute to IND and BLA filings

• Mentoring and supervising direct reports

Qualifications:

• PhD degree in life science or related field with 8+ years relevant experience working in bio- analytical field

• Strong background in PK, ADA and biomarker assay development for biologics

• Scientific and technical expertise in assay design, validation and implementation

• Experience in bio-analytical studies supporting antibody-drug conjugate (ADC) development preferred

• Experience working under GLP regulatory environment and preparing corresponding sections for IND/BLA submission

• Strong communication and leadership skills, cross-functional team leadership abilities required

• Experience working in startup environments or fast-paced companies in competitive markets highly desirable

Adcentrx Therapeutics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the lives of our employees and their families. Benefits include medical, vision and dental coverage, 401(k), company paid holidays, and stock options.

Adcentrx Therapeutics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. 

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