Senior Director, Biomarker and Translational SciencesJob SummarySeismic is seeking an experienced biomarker and translational sciences leader to build and lead the group that supports the generation of data at the heart of our development decisions. Reporting to the Chief Scientific Officer, you will be accountable for biomarker and bioanalytical assays and analyses, including pharmacokinetic (PK), immunogenicity, receptor occupancy, and pharmacodynamic (PD) assays, across our portfolio of research-stage and clinical-stage immunology programs, from discovery through IND-enabling studies and into the clinic.
You will be the bridge between Research and Clinical Development, working with both to align on biomarker and bioanalytical strategy and turning assays developed in Research into fit-for-purpose, clinical-grade assays run through our CRO and laboratory partners. Your group will combine assay scientists with a Biomarker and Nonclinical Operations lead who manages CRO execution, assay transfer and validation, and sample management, following Seismic's externalized operating model.
Key Responsibilities- Build and lead the Biomarker and Translational Sciences group, including assay scientists and the Biomarker and Nonclinical Operations lead. Set priorities across programs, develop team members' scientific and leadership capabilities, and foster a culture of rigor, ownership, and collaboration.
- Take accountability for PK, immunogenicity, and biomarker assays for Seismic's biologics, from method development and optimization through qualification and validation. Ensure that each assay is fit for purpose for the decisions it informs and meets GLP, GCP, and current regulatory expectations.
- Define the bioanalytical strategy for IND-enabling and clinical studies, including toxicokinetic and immunogenicity assessments and the assays, sample requirements, and timelines that each study needs.
- Provide scientific oversight of assay work at CROs through the Biomarker and Nonclinical Operations lead, who manages day-to-day CRO execution, assay transfer, validation documentation, and sample management. Serve as the senior scientific escalation point and approve key deliverables such as bioanalytical plans and validation reports.
- Support biomarker analysis efforts, including patient sample analysis, that deepen Seismic's understanding of mechanism and disease biology, using approaches such as high-sensitivity and multiplexed immunoassays, proteomics, flow and mass cytometry, transcriptomics, and serology. This will include managing collaborations with academic labs and vendor partnerships that provide access to patient samples, disease expertise, and novel technologies.
- Contribute the bioanalytical and biomarker content of regulatory documents, including INDs and CTAs, Investigator's Brochures, protocols, and clinical study reports, and support responses to health authority questions.
- Interpret and communicate assay and biomarker results in partnership with Research, Clinical Development, and Biometrics and Data Science, turning complex data into clear conclusions and recommendations for program teams and senior leadership.
Required Qualifications- PhD in immunology, biochemistry, or related discipline, with a strong understanding of immunology, immunotherapy, and autoimmunity.
- 12+ years of post-doctoral, group leadership experience in the biotechnology or pharmaceutical industry, with increasing responsibility for biomarker and translational sciences.
- Hands-on expertise in assay development for protein-based therapeutics, including ligand binding assays for PK and immunogenicity and cell-based assays such as flow cytometry and receptor occupancy, and knowledge of GLP and GCP requirements, regulatory guidance for bioanalytical method validation and immunogenicity testing, and fit-for-purpose approaches to biomarker assay validation.
- Demonstrated success advancing research-stage programs through IND and into the clinic, including delivery of validated clinical PK and immunogenicity assays.
- Proven experience overseeing bioanalytical CROs and biomarker vendors, with accountability for quality, timelines, and budgets.
- Experience building, leading, and developing teams of senior scientists and operations staff working across multiple projects.
- Excellent written and verbal communication skills and the ability to work effectively across internal teams and external partners.
Preferred Experience- Experience leading biomarker strategy and execution in immunology, autoimmune, inflammatory, or allergic disease clinical programs, including biologics with immunomodulatory mechanisms across T cell, B cell, and antibody-mediated diseases.
- Experience with high-dimensional biomarker technologies, such as proteomics, single-cell or bulk transcriptomics, and mass cytometry, and their integration with clinical data.
- Direct contributions and accountability for IND or CTA filings and representing the company in health authority interactions on bioanalytical or biomarker topics.
- Experience working in a lean environment.
Competencies- Scientific rigor and integrity, with sound judgment about what an assay and its data can and cannot support.
- Ability to bridge Research and Development, turning assay science into practical, well-sequenced plans that deliver decision-quality data on time.
- People leadership that develops scientists and operations staff and builds trust across disciplines and with external partners.
- Ownership and accountability for outcomes, balancing hands-on scientific contribution with effective oversight.
- Patient focus, connecting assay and biomarker decisions to participant safety and the potential impact of Seismic's medicines for patients.
OtherThis role is based in Watertown, Massachusetts, with in-office expectations consistent with Seismic's company policies and business needs.
Travel for CRO and vendor oversight, collaborator meetings, and scientific conferences, as needed.
The annual base salary range for this position is $220,000.00 - $280,000.00. Salary is determined by several factors including, but not limited to, relevant experience, skills, qualifications, education and internal benchmarks
