Executive Director, DMPK and 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

Executive Director, DMPK and Bioanalytics | Job Description

Soufflé Therapeutics is a biotech company focusing on the cell-type specific delivery of genetic medicines. Its team of driven scientists is making a mark in delivery of oligonucleotides to extrahepatic tissues. We thrive in a purpose-built lab and office space in Watertown. Come and join us in our quest!

Position Summary

Soufflé Therapeutics is seeking an Executive Director, DMPK and Bioanalytics who will own DMPK and bioanalytical strategy for our lead programs and set the foundation for every program that follows. The role integrates PK, PD, ADME, and biomarker data to inform candidate advancement, human PK projections, and human dose predictions, and leads the bioanalytical methods that generate that data.

This is a hands-on leadership role. The successful candidate will roll up their sleeves, manage external vendors to timelines, engage stakeholders across R&D, and serve as the recognized subject matter expert in DMPK and bioanalysis. The role reports to the head of Preclinical Development, and will start with one direct report (a bioanalytics hire), with the opportunity to build a small team as scope grows.

Key Responsibilities

• Integrate PK, PD, ADME, and biomarker data to inform candidate advancement, human PK projections, and human dose predictions; apply and manage modeling for dose projection, dose optimization, and exposure–response analysis.
• Lead bioanalytical strategy, development, transfer, and validation of highly sensitive and specific methods for candidate drugs and related compounds.
• Design, oversee, and interpret in vitro and in vivo ADME and bioanalytics studies.
• Select, manage, and oversee external vendors and CROs, including study plans, data transfer, and reports, to ensure high-quality data is delivered on time.
• Ensure compliance with GLP, GxP, and regulatory guidelines; lead authoring of key regulatory documents.
• Partner with Research Pharmacology, Research Analytics, Preclinical Development, Toxicology, Clinical Development, and program leadership, and interface with regulatory agencies as needed.
• Build and lead the bioanalytics team, starting with one direct report and growing as the pipeline requires.

What Success Looks Like

3 Months

• Ramped up on the two lead programs.
• Starting to influence upcoming programs, including the third.
• Gap assessment of existing vendors and infrastructure completed.

6 Months

• Leading the function on the cross-functional team and seen as the go-to contact.
• Rolling out systems and workflows to serve as the base plan for new programs.
• Programs already show clear fingerprints of your impact.
• Shifts made to external infrastructure to close identified gaps.

12 Months

• Updated base plan rolled out to enable new programs.
• Strategy in place for the function to address pipeline scalability.

Required Qualifications

• 12+ years of relevant experience in biotech or pharma, including 3+ years in a similar leadership/strategy role.
• Deep and hands-on functional experience in DMPK or bioanalytics, and experience managing the broader array of disciplines such as dose modeling and biomarkers.
• Experience with biologics or oligonucleotides (candidates are expected to bring one and learn the other).
• Experience across stages of development (pre-IND through Phase 1–3).
• Proven ability to manage external vendors to timelines.
• Hands-on, engaged leadership style with the ability to build relationships with stakeholders across functions.
• Driven, mature, no-nonsense approach; gets things done.
• Experience working on multiple different drugs.

Education

• PhD in a relevant scientific discipline.

Location

• Watertown, MA. This role, like every role at Souffle, comes with the expectation of 3-4 days in the office. We believe in face to face interactions and hallways conversations to accelerate our go to market speed.

At Soufflé Therapeutics, we are intentional about building an equitable culture. How we treat our people is reflective of this focus. This is an onsite position in Watertown, MA with flexibility as needed for collaboration and external engagements.