Senior Director, Bioanalysis

Madrigal Pharmaceuticals•Conshohocken, PA

11d•$273,366 - $314,989

About The Position

The Senior Director, Bioanalysis will provide strategic leadership and end-to-end accountability for bioanalytical sciences across a portfolio of clinical and nonclinical development programs. This individual will define and drive bioanalytical strategies that enable critical program decisions, ensuring generation of high-quality, regulatory-compliant data to support pharmacokinetic (PK) and pharmacodynamic (PD) evaluations. Operating within a predominantly outsourced model, this individual oversees external bioanalytical partners and serves as a key scientific leader in bioanalytical sciences across the organization. This role has significant cross-functional influence, contributing to regulatory engagement and successful advancement of innovative therapeutics across modalities.

Requirements

Comprehensive expertise in LC-MS/MS for quantitative bioanalysis in biological matrices is required
Deep expertise in bioanalytical assay development and validation is required
Thorough understanding of global regulatory expectations for bioanalytical methods and data is required
>15 years of experience
Demonstrated experience supporting both clinical and nonclinical development programs
Proven success leading bioanalytical activities in an outsourced/CRO-based model
Strong scientific judgment with the ability to balance rigor, speed, and risk
Effective communicator with demonstrated ability to influence cross-functional stakeholders

Nice To Haves

Familiarity with hybridization-based assays, ligand binding assays, and immunoassays is strongly preferred
postgraduate education and training may be included

Responsibilities

Define and implement bioanalytical strategies across a portfolio of programs through external partnerships to support all phases of clinical and nonclinical development programs ensuring scientific and regulatory rigor as well as identifying and guiding needed innovation
Select, manage, and evaluate CRO partners to ensure high-quality delivery, timeline adherence, and budget performance
Develop and implement a scalable CRO partnering strategy, including assay transfer, cross-validation, and lifecycle management across programs
Provide oversight of assay development, qualification, validation, and sample analysis conducted by external partners
Develop bioanalytical strategy for all modalities in the preclinical and clinical portfolio, e.g., small molecules, siRNA, and emerging therapeutic platforms
Ensure all bioanalytical activities meet global regulatory requirements (FDA, EMA, ICH guidelines, including ICH M10; GLP/GCP as applicable)
Review and approve bioanalytical documentation, including protocols, validation reports, study reports, and stability/interference assessments, ensuring data integrity and scientific rigor
Lead issue identification and resolution, driving continuous improvement in CRO performance and data quality
Partner cross-functionally with Clinical Operations, Translational Medicine, Regulatory, and other R&D functions to support program progression
Contribute to and lead bioanalytical strategy for regulatory submissions (IND/CTA, NDA/BLA), including regulator engagement and responses
Serve as the internal thought leader and subject matter expert in bioanalytical sciences, shaping platform and portfolio-level strategy
Represent the bioanalytical function externally through scientific conferences, publications, and collaborations