Strategic Leader, DMPK & Bioanalytics

Soufflé Therapeutics; Watertown (MA); On-site; USD 180,000 - 280,000; Full time

Job summary

Soufflé Therapeutics in Watertown, MA, seeks an Executive Director of DMPK and Bioanalytics who will own DMPK and bioanalytical strategy for lead programs, integrating PK, PD, ADME and biomarker data to inform dose predictions and human PK projections.

This hands-on leadership role will manage external vendors, build a small team, collaborate with R&D and regulatory teams, and serve as a subject matter expert setting foundation for pipeline advancement.

Qualifications

• 12+ years of relevant biotech/pharma experience, including leadership.
• Deep hands-on experience in DMPK or bioanalytics and dose modeling.
• Experience with biologics or oligonucleotides and cross-functional work.
• Exposure to pre-IND through Phase 1–3 development stages.
• Proven ability to manage external vendors to timelines and budgets.
• Hands-on, engaged leadership style with stakeholder relationship skills.

Responsibilities

• Integrate PK, PD, ADME and biomarker data to inform dose projections and human PK.
• Lead bioanalytical strategy, development, transfer and validation for candidates.
• Design and interpret in vitro and in vivo ADME and bioanalytics studies.
• Select and oversee external vendors and CROs to ensure timely, high-quality data.
• Ensure GLP/GxP compliance and contribute to regulatory documentation.
• Partner with multiple departments and regulators as needed.
• Build and lead the bioanalytics team, scaling with pipeline needs.

Skills

DMPK

Bioanalytics

Leadership

Dose modeling

Biologics

Oligonucleotides

Vendor management

Cross-functional

Regulatory knowledge

Drug development

Education

PhD in relevant scientific discipline

Job description

Soufflé Therapeutics in Watertown, MA, seeks an Executive Director of DMPK and Bioanalytics who will own DMPK and bioanalytical strategy for lead programs, integrating PK, PD, ADME and biomarker data to inform dose predictions and human PK projections.

This hands-on leadership role will manage external vendors, build a small team, collaborate with R&D and regulatory teams, and serve as a subject matter expert setting foundation for pipeline advancement.