Executive Director, Head of Bioanalytical Sciences

RemoteWork; Waltham (MA); On-site; USD 190,000 - 280,000; Full time

Job summary

Dianthus Therapeutics in the United States seeks an Executive Director, Head of Bioanalytical Sciences to own the bioanalytical strategy across research, translational, and clinical development. You will serve as the senior scientific authority for assays and biomarker work.

Lead the Bioanalytical Sciences function, recruit top talent, and ensure regulatory readiness for submissions while guiding program decisions with rigorous data interpretation.

Qualifications

• PhD or advanced equivalent in a relevant scientific discipline.
• 15+ years of progressive bioanalytical experience with leadership responsibilities.
• Proven track record leading bioanalytical strategy across programs and development stages.
• Deep expertise in method development, qualification, validation, transfer, and data review.
• Strong knowledge of PK, PD, biomarker assays, ligand binding, and LC MS/MS.
• Experience with GLP/GCP, data integrity, inspection readiness, and regulatory submissions.

Responsibilities

• Define and execute the company wide bioanalytical strategy and capability roadmap.
• Provide scientific oversight for assay strategy, development, validation, and data interpretation.
• Ensure assays are fit for purpose, compliant with regulatory expectations, and support key program decisions.
• Lead resolution of complex assay and vendor issues in partnership with Quality and external labs.
• Own or oversee regulatory Content for submissions and health authority interactions.
• Build and develop the Bioanalytical Sciences function, including recruitment and performance management.

Skills

Bioanalytical leadership

Strategic planning

Method development

Regulatory submissions

LC-MS/MS

Data review

Regulatory liaison

Education

PhD in biosciences

Job description

About the role

Dianthus Therapeutics is developing novel therapies for autoimmune diseases. The Executive Director, Head of Bioanalytical Sciences will own the bioanalytical strategy and execution across research, translational, and clinical development, serving as the senior scientific authority for assays and biomarker work.

What you'll do

• Define and execute the company wide bioanalytical strategy and capability roadmap
• Provide scientific oversight for assay strategy, development, validation, and data interpretation
• Ensure assays are fit for purpose, compliant with regulatory expectations, and support key program decisions
• Lead resolution of complex assay and vendor issues in partnership with Quality and external labs
• Own or oversee regulatory Content for submissions and health authority interactions
• Build and develop the Bioanalytical Sciences function, including recruitment and performance management

What they're looking for

• PhD or advanced equivalent in a relevant scientific discipline
• 15 or more years of progressive bioanalytical experience with leadership responsibilities
• Proven track record leading bioanalytical strategy across programs and development stages
• Deep expertise in method development, qualification, validation, transfer, and data review
• Strong knowledge of platforms such as PK, PD, biomarker assays, ligand binding, and LC MS/MS
• Experience with GLP/GCP, data integrity, inspection readiness, and regulatory submissions

For applicants in Nigeria

• The listing states remote work is possible; confirm any country specific eligibility during interview
• The listing does not specify a timezone requirement; confirm expectations before interviewing
• The listing does not specify employment type or pay currency; confirm these details during process