Executive Director, Bioanalytical Development
About the Company
Innovative biotech company developing life-transforming therapeutics for genetically driven diseases.
Industry
Biotechnology
Type
Public Company
Founded
2018
Employees
51-200
Categories
About the Role
The Company is seeking an Executive Director, Head of Bioanalytical Development to lead the bioanalytical capabilities for the advancement of therapeutics targeting genetically driven neuromuscular diseases. The successful candidate will be responsible for the development, validation, and implementation of robust PK and immunogenicity assays to support the transition from bench to clinic, covering the entire development process from discovery through IND, late-stage clinical development, and licensure. This role involves building and leading a high-performing team, overseeing assay development for PK and ADA, and ensuring compliance with global regulatory standards. The Executive Director will also be the primary scientific interface with external partners, driving strategic initiatives, and championing the adoption of cutting-edge technologies in bioanalysis.
Applicants for this role at the company should have a Ph.D. or equivalent in biochemistry, pharmacology, or a related field, with a minimum of 10-12 years' experience in bioanalytical sciences within the biopharmaceutical industry. The ideal candidate will have a proven track record of leadership, deep expertise in bioanalytical assay development for both biologics and small molecules, and a strong understanding of regulatory requirements. Experience in a fast-paced biotech environment, a history of innovation in bioanalysis, and excellent communication, organizational, and project management skills are essential. The role requires the ability to influence cross-functional teams, drive strategic initiatives, and ensure the highest quality and regulatory compliance in all bioanalytical operations.
Hiring Manager Title
head of Translational Biomarkers
Travel Percent
Less than 10%
Functions
Director Development • Philadelphia, PA, United States