About Seismic

Seismic Therapeutic^TM is a clinical-stage biotechnology company making a major shift in how immunology therapies are discovered and developed. The company has a growing preclinical stage best-in-class and first-in-class biologics pipeline, derived from its integrated IMPACT platform, to control dysregulated adaptive immunity and address multiple autoimmune diseases. The company is backed by a strong syndicate of life science investors and is located in the Boston area biotechnology hub. For more information, please visit www.seismictx.com and follow us on LinkedIn and on X @Seismic_Tx.

At our core, we are focused on phenomenal science, supportive culture, a superstar team, meritocracy, and patient-centric goals. Seismic has the tools, skills, ideas and people to make this a reality. Success will be the discovery and development of effective therapies for patients in need, and we invite you to become a part of that. This is a terrific opportunity for an experienced bioanalytical and biomarker operations professional to build the operational foundation for our assays and samples and join our small, dynamic and high-performing team.

Job Summary

Seismic is seeking a motivated Senior Associate Scientist to join our In Vivo Pharmacology team in support of autoimmune disease programs. This hands-on, in vivo/in vitro-based role centers on autoimmune and inflammatory models, including immune cell modulation and pharmacodynamic assessment of novel therapeutic candidates. The successful candidate will help schedule and execute preclinical in vivo, ex vivo and in vitro studies for research programs, performing procedures with a high degree of proficiency in a fast-paced, collaborative environment.

Key Responsibilities

• Execute in vivo and in vitro studies supporting autoimmune disease programs, evaluating immune cell modulation, inflammatory readouts, pharmacokinetics, pharmacodynamics and therapeutic efficacy
• Perform hands-on in vivo procedures, including compound administration (RO, IP, IV and SC), survival bleedings, blood and tissue collection, necropsy and clinical observations
• Partner with research leads on study design, endpoint selection, data interpretation and troubleshooting
• Coordinate study logistics, including dosing schedules, sample collection plans, reagent preparation and communication with research teams
• Analyze, visualize and summarize study data; maintain clear, timely records of data, sample inventories, protocols and study summaries
• Ensure all work complies with IACUC, animal welfare, biosafety and institutional policies

Required Qualifications

• BS or MS in Biology, Immunology, Pharmacology or a related field with 6+ (BS) / 3+ (MS) years of hands-on in vivo research experience and a demonstrated ability to execute studies with increasing independence
• Proficiency in common in vivo procedures, including mouse handling, dosing, blood collection, tissue harvest, necropsy and clinical monitoring, MSD/ELISA (preferred), flow cytometry (preferred).
• Experience with autoimmune or inflammatory disease models preferred
• Proficiency with GraphPad Prism and Excel preferred
• Strong attention to detail and commitment to high-quality data generation, documentation and reproducibility
• Commitment to animal welfare, ethical research practices and compliance with IACUC-approved protocols

Other

This role is based in Watertown, Massachusetts, with in-office expectations consistent with Seismic’s company policies and business needs, including regular presence in our laboratory.

The annual base salary range for this position is $95,000.00 – $120,000.00. Salary is determined by several factors including, but not limited to, relevant experience, skills, qualifications, education and internal benchmarks.

APPLY HERE

Seismic Therapeutic is an equal opportunity employer. We welcome applicants of every background and make employment decisions without regard to race, color, national origin, sex, sexual orientation, gender identity, religion, age, disability, veteran status, pregnancy, genetic information, or any other status protected by federal, state, or local law. If you need an accommodation during the application or interview process, please let us know.

About Seismic

Seismic Therapeutic^TM is a clinical-stage biotechnology company making a major shift in how immunology therapies are discovered and developed. The company has a growing preclinical stage best-in-class and first-in-class biologics pipeline, derived from its integrated IMPACT platform, to control dysregulated adaptive immunity and address multiple autoimmune diseases. The company is backed by a strong syndicate of life science investors and is located in the Boston area biotechnology hub. For more information, please visit www.seismictx.com and follow us on LinkedIn and on X @Seismic_Tx.

At our core, we are focused on phenomenal science, supportive culture, a superstar team, meritocracy, and patient-centric goals. Seismic has the tools, skills, ideas and people to make this a reality. Success will be the discovery and development of effective therapies for patients in need, and we invite you to become a part of that. This is a terrific opportunity for an accomplished immunologist and assay scientist to build and lead our biomarker and translational sciences group and join our small, dynamic and high-performing team.

Job Summary

Seismic 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.

Other

This 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

APPLY HERE

Seismic Therapeutic is an equal opportunity employer. We welcome applicants of every background and make employment decisions without regard to race, color, national origin, sex, sexual orientation, gender identity, religion, age, disability, veteran status, pregnancy, genetic information, or any other status protected by federal, state, or local law. If you need an accommodation during the application or interview process, please let us know.

About Seismic

Seismic Therapeutic^TM is a clinical-stage biotechnology company making a major shift in how immunology therapies are discovered and developed. The company has a growing preclinical stage best-in-class and first-in-class biologics pipeline, derived from its integrated IMPACT platform, to control dysregulated adaptive immunity and address multiple autoimmune diseases. The company is backed by a strong syndicate of life science investors and is located in the Boston area biotechnology hub. For more information, please visit www.seismictx.com and follow us on LinkedIn and on X @Seismic_Tx.

At our core, we are focused on phenomenal science, supportive culture, a superstar team, meritocracy, and patient-centric goals. Seismic has the tools, skills, ideas and people to make this a reality. Success will be the discovery and development of effective therapies for patients in need, and we invite you to become a part of that. This is a terrific opportunity for a talented bench scientist to develop the assays that show how our medicines work, from the laboratory into the clinic, and join our small, dynamic and high-performing team.

Job Summary

Seismic is seeking a bench scientist to develop and optimize the assays that support our research-stage and clinical-stage immunology programs. You will develop pharmacokinetic (PK), anti-drug antibody (ADA), target engagement, and pharmacodynamic (PD) assays for Seismic’s biologics in human, non-human primate (NHP), and mouse samples, using ligand binding and flow cytometry platforms.

Your assays will inform decisions from candidate selection through IND-enabling studies and into the clinic. You will work closely with scientists in research and with the clinical team to make sure each assay answers the right question, and with the Translational Sciences group to prepare assays for transfer to our CRO partners. This is a hands-on, laboratory-based role in a small team, where your work will move quickly from the bench to the clinic.

Key Responsibilities

• Design, develop, and optimize ligand binding assays, such as ELISA and electrochemiluminescence (MSD) formats, or Mass Spec-based PK assays to measure drug concentrations or anti-drug antibodies in human, NHP, and mouse matrices.
• Develop and optimize flow cytometry assays for target engagement, receptor occupancy, and pharmacodynamic readouts, including immunophenotyping of relevant immune cell populations.
• Qualify assays to a fit-for-purpose standard, including sensitivity, specificity, precision, and drug tolerance where applicable, and identify and characterize the critical reagents each assay depends on.
• Analyze samples from discovery and IND-enabling studies and interpret and present results to project teams.
• Prepare assay transfer packages, including methods, critical reagents, and qualification data, and serve as the technical point of contact for CRO scientists during assay transfer and troubleshooting.
• Maintain thorough, contemporaneous records in an electronic laboratory notebook, and write methods, SOPs, and technical reports consistent with Seismic’s quality standards.
• Evaluate new assay technologies and approaches that could improve sensitivity, throughput, or the biological questions Seismic can answer.

Required Qualifications

• PhD in immunology, biochemistry, or a related discipline, with at least 3 years of experience in the biotechnology or pharmaceutical industry or at a CRO.
• Strong hands-on experience developing and optimizing ligand binding assays for biologics, such as PK and ADA assays on ELISA or MSD platforms.
• Strong hands-on experience developing and optimizing multicolor flow cytometry assays, including panel design and data analysis.
• Experience working with samples from more than one species, such as human, NHP, or mouse.
• Good documentation skills, with careful attention to detail and data integrity.
• Ability to work well as part of a small team, manage several projects at once, and communicate results clearly to scientific and clinical colleagues.

Preferred Experience

• Experience developing target engagement or receptor occupancy assays for biologics.
• Familiarity with regulatory expectations for bioanalytical method validation and immunogenicity testing, and experience transferring assays to a CRO.
• Background in immunology, allergy, autoimmune, or inflammatory disease research.
• Experience working in a lean environment.

Competencies

• Scientific rigor and integrity, with sound judgment about whether an assay is fit for its intended purpose.
• Persistent, hands-on problem solving when assays do not perform as expected.
• Collaboration and clear communication within a small team and across Research and Clinical Development.
• Patient focus, connecting the quality of each assay to the decisions it informs and the potential impact of Seismic’s medicines for patients.

Other

This role is based in Watertown, Massachusetts, and is laboratory-based, with in-office expectations consistent with Seismic’s company policies and business needs.

Limited travel for CRO visits and scientific meetings, as needed.

The annual base salary range for this position is $110,000.00 – $150,000.00. Salary is determined by several factors including, but not limited to, relevant experience, skills, qualifications, education and internal benchmarks.

APPLY HERE

Seismic Therapeutic is an equal opportunity employer. We welcome applicants of every background and make employment decisions without regard to race, color, national origin, sex, sexual orientation, gender identity, religion, age, disability, veteran status, pregnancy, genetic information, or any other status protected by federal, state, or local law. If you need an accommodation during the application or interview process, please let us know.

About Seismic

Seismic Therapeutic^TM is a clinical-stage biotechnology company making a major shift in how immunology therapies are discovered and developed. The company has a growing preclinical stage best-in-class and first-in-class biologics pipeline, derived from its integrated IMPACT platform, to control dysregulated adaptive immunity and address multiple autoimmune diseases. The company is backed by a strong syndicate of life science investors and is located in the Boston area biotechnology hub. For more information, please visit www.seismictx.com and follow us on LinkedIn and on X @Seismic_Tx.

At our core, we are focused on phenomenal science, supportive culture, a superstar team, meritocracy, and patient-centric goals. Seismic has the tools, skills, ideas and people to make this a reality. Success will be the discovery and development of effective therapies for patients in need, and we invite you to become a part of that. This is a terrific opportunity for an experienced bioanalytical and biomarker operations professional to build the operational foundation for our assays and samples and join our small, dynamic and high-performing team.

Job Summary

Seismic is seeking a biomarker operations lead to ensure that the assays and samples behind our development decisions are managed with rigor, from the CRO laboratory to long-term storage. Reporting to the Senior Director, Biomarker and Translational Sciences, you will own the day-to-day execution of bioanalytical and biomarker work at CROs and specialty laboratories for Seismic’s bioanalytical efforts and clinical studies, following Seismic’s externalized operating model.

You will manage assay transfer and optimization at CROs, oversee method validation and sample analysis, and manage clinical and nonclinical samples throughout their lifecycle, both at our partners and in our own laboratory. You will also be accountable for ensuring that our laboratory operates to GLP and GCP standards.

Candidates should demonstrate ownership of bioanalytical and sample operations across multiple programs, including CRO selection and budgets, establishment of sample management systems and laboratory compliance programs.

Key Responsibilities

• Serve as the operational lead for bioanalytical and biomarker CROs and specialty laboratories, managing scopes of work, contracts, timelines, budgets, and accruals. Support vendor selection and qualification, track vendor performance, and participate in CRO audits with Quality. This will involve CRO calls in off hours.
• Manage the transfer of assays developed at Seismic to CROs, and partner with CRO scientists on the optimization, qualification, and validation of PK, immunogenicity, target engagement, and biomarker assays.
• Review key bioanalytical documents, including method validation plans and reports, bioanalytical and sample analysis plans, and sample analysis reports, to confirm that they are complete, accurate, and consistent with GLP, GCP, and current regulatory guidance.
• Oversee clinical sample processing and analysis at CROs and central laboratories, including collection and processing requirements, laboratory manuals, kits, shipments, and resolution of sample queries. Partner with Clinical Operations so that site procedures protect sample quality.
• Own Seismic’s sample management across the sample lifecycle, maintaining a complete and current inventory of clinical and nonclinical samples held at CROs, vendors, and in our own laboratory, including chain of custody, reconciliation, consent-related use limitations, and final disposition.
• Ensure that samples are appropriately stored at vendors and in Seismic’s laboratory, with temperature-controlled storage, monitoring, alarm response, and documentation that meet GLP and GCP expectations, where appropriate.
• Coordinate toxicokinetic and immunogenicity sample analysis for IND-enabling toxicology studies, ensuring that bioanalytical reports are delivered on time for inclusion in study reports and regulatory submissions.
• Define data transfer specifications with CROs and Biometrics and Data Science, so that bioanalytical and biomarker data are delivered in a timely, standardized form ready for integration with clinical data.
• Build scalable trackers, practices, and SOPs for bioanalytical and sample operations that support an expanding pipeline without introducing unnecessary bureaucracy.

Required Qualifications

• BS, MS, or PhD in immunology, biochemistry, biology, or a related discipline, with 7+ years of relevant experience in the biotechnology or pharmaceutical industry, a CRO, or a central laboratory.
• Hands-on laboratory experience with ligand binding, mass spec, and/or cell-based assays, sufficient to guide assay transfer, optimization, and troubleshooting with CRO scientists.
• Proven experience managing bioanalytical CROs, central laboratories, or specialty laboratories, including scopes of work, contracts, budgets, and accruals.
• Demonstrated experience with clinical and nonclinical sample management, including sample logistics, chain of custody, reconciliation, and long-term storage.
• Working knowledge of GLP and GCP requirements, regulatory guidance for bioanalytical method validation and immunogenicity testing, and data integrity expectations.
• Strong organization and documentation discipline and excellent written and verbal communication skills.

Preferred Experience

• Experience establishing or maintaining a GLP- or GCP-compliant laboratory, including participation in audits or inspections.
• Experience supporting biologics programs through IND-enabling studies and early-phase clinical trials, ideally in immunology, allergy, autoimmune, or inflammatory disease.
• Experience as operations lead in a lean environment.

Competencies

• Operational discipline, maintaining careful attention to quality, documentation, and traceability across many concurrent studies and partners.
• Quality and compliance mindset, with sound judgment about when an issue requires escalation.
• Proactive problem solving that anticipates risks to timelines, samples, and data before they become issues.
• Collaborative partnership with scientists, CROs, and cross-functional colleagues, building trust through reliability and clear communication.
• Patient focus, treating every sample as a contribution from a study participant and connecting operational decisions to participant safety and the potential impact of Seismic’s medicines.

Other

This role is based in Watertown, Massachusetts, with in-office expectations consistent with Seismic’s company policies and business needs, including regular presence in our laboratory.

Limited travel for CRO and vendor visits and audits, as needed.

The annual base salary range for this position is $170,000.00 – $230,000.00. Salary is determined by several factors including, but not limited to, relevant experience, skills, qualifications, education and internal benchmarks.

APPLY HERE

Seismic Therapeutic is an equal opportunity employer. We welcome applicants of every background and make employment decisions without regard to race, color, national origin, sex, sexual orientation, gender identity, religion, age, disability, veteran status, pregnancy, genetic information, or any other status protected by federal, state, or local law. If you need an accommodation during the application or interview process, please let us know.

About Seismic

Seismic Therapeutic is a clinical-stage biotechnology company making a major shift in how immunology therapies are discovered and developed. The company has a growing preclinical stage best-in-class and first-in-class biologics pipeline, derived from its integrated IMPACT platform, to control dysregulated adaptive immunity and address multiple autoimmune diseases. The company is backed by a strong syndicate of life science investors and is located in the Boston area biotechnology hub. For more information, please visit www.seismictx.com and follow us on LinkedIn and on X @Seismic_Tx.

At our core, we are focused on phenomenal science, supportive culture, a superstar team, meritocracy, and patient-centric goals. Seismic has the tools, skills, ideas and people to make this a reality. Success will be the discovery and development of effective therapies for patients in need, and we invite you to become a part of that. This is a terrific opportunity for a highly motivated, hands-on analytical development lead to join our small, dynamic and high-performing Development team.

Job Summary

Seismic is seeking an analytical development and QC lead to join our growing Development team. You will lead analytical strategies and execution across our biologics programs targeting the adaptive immune system, combining scientific expertise with hands-on oversight of work performed at CDMOs, CROs, and other contract organizations following Seismic’s highly externalized operating model.

You will bring deep analytical development and quality control expertise to lead analytical activities across Seismic’s portfolio. Your primary responsibilities will include product characterization and comparability, analytical control strategies and specifications, method development, qualification, validation, and transfer, release and stability studies, and analytical lifecycle management. You will also provide analytical support for regulatory submissions. As an integral member of the CMC team, you will partner closely with colleagues to define and execute integrated development strategies.

This position may be filled at the Director or Senior Director level, depending on experience, technical leadership, and scope of prior responsibilities. Senior Director candidates should demonstrate broader ownership of analytical strategies across programs and leadership of complex CMC decisions.

Key Responsibilities

• Provide analytical leadership across Seismic’s biologic portfolio, aligning activities with program milestones, risk-based decisions, and regulatory needs.
• Develop and lead phase-appropriate analytical lifecycle management strategy for Seismic’s pipeline of novel antibody and enzyme therapeutics. Integrate analytical development strategies in integrated CMC development strategies, aligning deliverables with program milestones and risks, and ensure clear accountability across programs.
• Manage outsourced analytical workstreams performed at CDMOs, CROs, and contract testing laboratories, including scope definition, timelines, budget, and performance management.
• Meet CMC timelines and program deliverables, communicate key technical and operational risks, drive cross-functional decisions and appropriate escalation to Seismic leadership to drive timely decisions.
• Define and implement analytical control strategies, including product characterization, key and critical quality attributes, raw material and in-process testing as appropriate, drug substance and drug product specifications, stability programs and supporting scientific justifications.
• Lead analytical development, optimization, qualification, validation, transfer, and lifecycle management. Assess method gaps and ensure methods are suitable for their intended use and development stage.
• Direct physicochemical, biochemical, and functional characterization of biologics, including monoclonal antibodies, Fc-fusion proteins, and other engineered protein modalities. Interpret structure, purity, impurity, and potency data, understand product quality, identify development risks and gaps, and propose and resolve risks and gaps.
• Design and oversee analytical comparability assessment for process, formulation, scale, site, and manufacturing changes, including study plans, interpretation, and scientific justifications supporting continued clinical development.
• Critically review analytical methods, protocols, qualification and validation reports, test data, certificates of analysis and testing, and technical reports. Maintain complete, traceable analytical records and communicate progress and risks to the CMC and Program Teams as appropriate.
• Partner with Quality and external laboratories to investigate and resolve atypical results, out-of-specification and out-of-trend results, deviations, and method performance concerns. Provide technical input to root cause analysis, corrective and preventive actions, and change controls as appropriate.
• Author, review and approve analytical sections of CMC regulatory submissions and maintain and organize analytical source documents. Provide analytical subject matter expertise responding to health authorities’ questions and support regulatory interactions as needed.

Required Qualifications

• Willingness to roll up your sleeves and take a hands-on approach to reviewing data and technical documents, investigating and resolving analytical issues, and driving activities to completion in a lean team environment.
• PhD, MS, or BS in analytical chemistry, biochemistry, chemistry, pharmaceutical sciences, chemical engineering, or a related discipline with 10+ years of progressive biotechnology or pharmaceutical industry experience, including substantial responsibility for analytical development of biologic therapeutics.
• Demonstrated expertise in analytical development for monoclonal antibodies, Fc-fusion proteins, and/or other engineered protein therapeutics, including the relationship between process development, product quality attributes, and analytical control strategy.
• Proven experience directing analytical activities at CDMOs, CROs, and contract testing laboratories, including technical oversight, troubleshooting, method transfer, data review, performance management, delivery against timelines and budget.
• Experience with analytical method qualification, validation, transfer, specification setting, reference standards management and qualification, stability studies, and comparability assessments for biologics analytical technologies, including chromatographic, electrophoretic, mass spectrometric, biophysical, binding assays, and cell-based potency assays.
• Extensive knowledge of cGMP requirements and applicable FDA, EMA, ICH, and other global regulatory expectations for analytical development of biologics, including experience contributing to CMC regulatory submissions.

Preferred Experience

• Advanced degree (Ph.D. preferred) in a relevant scientific discipline.
• Experience advancing biologics from IND-enabling development through multiple stages of clinical development.
• Experience with phase-appropriate binding assays and cell-based assays for demonstrating product with product-specific mechanism-of-action for complex biologics.
• Experience establishing or refining specifications and analytical control strategies as programs transition from early- to later-stage clinical development.
• Experience leading comparability following process, formulation, scale, site, or manufacturing changes and responding to health authority questions related to analytical development.
• Experience working in a venture-backed biotechnology company or another lean environment where senior team members combine strategic thinking with hands-on execution.

Competencies

• Ownership and accountability for outcomes, with urgency, attention to detail, and follow-through required to complete them reliably.
• Scientific and technical judgment, with the ability to use data and first principles to solve complex analytical development problems and make pragmatic recommendations.
• Collaborative leadership that builds trust across CMC disciplines and with external partners, supports clear functional ownership, invites input, and enables timely, well-informed decisions.
• Operational discipline, including working independently, maintaining clear documentation and visibility, proactively following up, and applying thoughtful risk-based thinking.
• Adaptability and learning agility in the face of ambiguity, changing priorities, and the hands-on work required to support an emerging pipeline.
• Ability to develop and implement a patient-focused analytical strategy, connecting analytical and CMC decisions to product quality, clinical execution, regulatory requirements, and the potential impact of Seismic’s medicines for patients.

Other

This role is based in Watertown, Massachusetts, with in-office expectations consistent with Seismic’s company policies and business needs.

Travel domestically and internationally as needed to support analytical activities at CDMOs, contract laboratories, and other external partners.

The annual base salary range for this position is $195,000.00 – $300,00.00. The base salary is determined by several factors including, but not limited to, relevant experience, skills, qualifications, education and internal benchmarks.

APPLY HERE

Seismic Therapeutic is an equal opportunity employer. We welcome applicants of every background and make employment decisions without regard to race, color, national origin, sex, sexual orientation, gender identity, religion, age, disability, veteran status, pregnancy, genetic information, or any other status protected by federal, state, or local law. If you need an accommodation during the application or interview process, please let us know.

About Seismic

Seismic Therapeutic is a clinical-stage biotechnology company making a major shift in how immunology therapies are discovered and developed. The company has a growing preclinical stage best-in-class and first-in-class biologics pipeline, derived from its integrated IMPACT platform, to control dysregulated adaptive immunity and address multiple autoimmune diseases. The company is backed by a strong syndicate of life science investors and is located in the Boston area biotechnology hub. For more information, please visit www.seismictx.com and follow us on LinkedIn and on X @Seismic_Tx.

At our core, we are focused on phenomenal science, supportive culture, a superstar team, meritocracy, and patient-centric goals. Seismic has the tools, skills, ideas and people to make this a reality. Success will be the discovery and development of effective therapies for patients in need, and we invite you to become a part of that. This is a terrific opportunity for a highly motivated, hands-on biostatistician and data scientist to build and lead the biometrics function and join our small, dynamic and high-performing Clinical Development team.

Job Summary

Seismic is seeking a biometrics and data science lead to join our growing Clinical and Development team. You will perform and oversee biostatistics for our clinical programs, combining hands-on statistical expertise with oversight of data management and statistical programming performed by CROs, following Seismic’s externalized operating model.

You will also serve as the steward of Seismic’s clinical and complex biomarker data, ensuring that data are organized, standardized, and linked to available biospecimens and external collaborations. As an integral member of the Clinical Development team, you will partner closely with colleagues in Immunology, Translational Sciences, Clinical Operations, and Regulatory.

This position may be filled at the Director or Senior Director level, depending on experience, technical leadership, and scope of prior responsibilities. Senior Director candidates should demonstrate broader ownership of biometrics strategy across programs, including vendor strategy and budgets, health authority interactions, and readiness to build and lead a team.

Key Responsibilities

• Conduct hands-on biostatistics for Seismic’s clinical studies, including study design input, sample size calculations, authoring/reviewing statistical analysis plans, and performing and interpreting analyses. Provide statistical input to protocols, clinical study reports, regulatory submissions, and safety review committees, and oversee any biostatistics activities delegated to CROs.
• Oversee CRO data management from database build through lock, including eCRF and EDC design review, data management plans, edit checks, ongoing data review and reconciliation, and database lock readiness.
• Oversee CRO statistical programming, including SDTM and ADaM datasets and tables, listings, and figures, and independently review and validate key outputs. Select CRO biometrics partners and manage their scope, timelines, and performance.
• Organize clinical and biomarker data for each study and project in a compliant way and keep them current as new data arrive, including logs of issues that arise, how they are resolved, and which decisions are made.
• Coordinate data transfers from laboratories and biomarker vendors, and clean and standardize clinical and biomarker data, such as transcriptomics, proteomics, and flow cytometry, for integration and analysis.
• Perform exploratory analyses linking biomarkers to clinical outcomes.
• Partner closely with colleagues in Immunology, Biomarker & Translational Sciences, and Clinical Development, and Operations, to translate scientific and clinical questions into statistical and data deliverables.
• Build scalable biometrics practices, standards, and SOPs that support an expanding clinical pipeline without introducing unnecessary bureaucracy.

Required Qualifications

• Willingness to roll up your sleeves and take a hands-on approach to cleaning and standardizing data, creating a data-driven statistical analysis plan for each project, reviewing statistical deliverables, performing and/or overseeing analyses of clinical and multi-omic biomarker data, and driving activities to completion in a lean team environment.
• MS in biostatistics, statistics, or a related quantitative discipline and 8+ years of biostatistics experience in the biotechnology or pharmaceutical industry, or 12+ years for the Senior Director level.
• Hands-on experience designing clinical studies, authoring statistical analysis plans, and conducting analyses, with proficiency in relevant programming tools (e.g., SAS, R, Python).
• Proven experience overseeing CROs for biostatistics, statistical programming, and data management, with working knowledge of EDC systems and CDISC standards.
• Working knowledge of ICH-GCP and E9 guidelines and data integrity requirements for clinical data.
• Working familiarity with high-dimensional biomarker data and their integration with clinical trial data.
• Excellent written and verbal communication skills, strong organization and documentation discipline, and the ability to work effectively across internal teams and external partners.

Preferred Experience

• Experience supporting immunology, autoimmune, inflammatory, or allergic disease clinical programs.
• Experience with early-phase studies, biologics, and PK/PD data.
• Hands-on analysis of omics data, such as flow cytometry, bulk or single-cell transcriptomics.
• Experience as the first or sole statistician in a venture-backed biotechnology company or another lean environment, including management of academic collaborations.

Competencies

• Ownership and accountability for outcomes, balancing hands-on contribution with effective oversight.
• Statistical rigor and integrity, with sound judgment about what data can and cannot support.
• Operational discipline, maintaining careful attention to data quality, documentation, and traceability.
• Collaborative leadership that builds trust across disciplines and with CRO and external partners.
• Patient focus, connecting data integrity and analytical decisions to participant safety and the potential impact of Seismic’s medicines for patients.

Other

This role is based in Watertown, Massachusetts, with in-office expectations consistent with Seismic’s company policies and business needs.

Limited travel for collaborator, vendor, and scientific meetings, as needed.

The annual base salary range for this position is $200,000.00 – $315,000.00. Salary is determined by several factors including, but not limited to, relevant experience, skills, qualifications, education and internal benchmarks.

APPLY HERE

Seismic Therapeutic is an equal opportunity employer. We welcome applicants of every background and make employment decisions without regard to race, color, national origin, sex, sexual orientation, gender identity, religion, age, disability, veteran status, pregnancy, genetic information, or any other status protected by federal, state, or local law. If you need an accommodation during the application or interview process, please let us know.

About Seismic

Seismic Therapeutic is making a major shift in how immunology therapies are discovered and developed, enabled by machine learning. We have brought together a stellar team of leading immunology drug developers, machine learning innovators and company builders who are charting new drug discovery territory to open better and faster ways to make medicines for patients with immune-driven diseases.

At our core, we are focused on phenomenal science, supportive culture, a superstar team, meritocracy, and patient-centric goals. Seismic has the tools, skills, ideas and people to make this a reality. Success will be the discovery and development of effective therapies for patients in need, and we invite you to become a part of that.

Job Summary

This is a terrific opportunity for a highly motivated, hands-on Clinical Trial Manager to join our small, dynamic and high-performing clinical operations team.

We are adding this position to support the Director, Clinical Operations as Seismic’s clinical portfolio grows. In this role, you will support the operational planning and execution of early-phase clinical studies under the direction of the Director. You will manage defined study activities and workstreams from study start-up through database lock and closeout, coordinate internal and external partners, maintain operational visibility, and escalate risks with recommendations. The role will initially support our lead clinical program and expand as Seismic’s pipeline advances.

This position may be filled at the Clinical Trial Manager or Senior Clinical Trial Manager level, depending on experience.

Key Responsibilities

• Coordinate day-to-day operational activities for clinical studies both within Seismic and with CRO and other vendors, including tracking delivery against scope, timelines, budget, quality standards, and study objectives, and promptly escalate material risks or decisions.
• Ensure study plans are developed and maintained including risk and issue logs, enrollment forecasts, meeting actions, and operational metrics. Identify emerging risks, investigate options, and provide recommendations to the Director and study team.
• Contribute to and coordinate the development, review, approval, and implementation of protocols and amendments, informed consent forms, eCRFs and completion guidelines, monitoring and enrollment plans, pharmacy and laboratory manuals, study-specific procedures, and site tools.
• Coordinate sponsor oversight of monitoring activities, including review of monitoring plans and reports, trend analysis, co-monitoring or oversight visits as appropriate, and follow-up of site-level findings. Review data and operational quality indicators, including protocol deviations, query trends, and data-cleaning backlogs.
• Maintain complete, current, and inspection-ready documentation for assigned studies, including TMF oversight and follow-up of filing gaps.
• Ensure coordination of other key cross-functional vendors for investigational product and ancillary supply (in collaboration with CMC and Quality) and bioanalytical and exploratory laboratory testing (in collaboration with Translational Sciences)
• Coordinate cross-functional study activities and maintain clear communication including facilitating meeting agendas and minutes, ensuring documentation of decisions and actions, and clear next steps to internal and external stakeholders.
• Support implementation of Clinical Operations SOPs, templates, vendor governance practices, systems, and lessons learned. Provide practical feedback based on assigned-study experience to help establish Seismic’s clinical operations capabilities.

Required Qualifications

• Bachelor’s degree in life sciences, nursing, pharmacy, or a related discipline; advanced degree is a plus.
• 5+ years (Clinical Trial Manager) or 8+ years (Senior Clinical Trial Manager) of progressive clinical research experience, including experience coordinating or managing clinical study activities in Phase 1 and/or Phase 2 trials. Experience in a biotechnology, pharmaceutical, or CRO setting is acceptable; sponsor-side and global trial experience is a plus.
• Experience in CRO/Vendor Management; domestic and international experience is a plus.
• Demonstrated ability to manage assigned study workstreams, maintain timelines and trackers, coordinate cross-functional deliverables, and escalate risks and decisions appropriately.
• Working knowledge of ICH-GCP, applicable FDA and global regulatory requirements, clinical trial SOPs, and inspection-readiness expectations.
• Proficiency with clinical systems and tools such as EDC, CTMS, eTMF, IRT/RTSM, Microsoft Excel, PowerPoint, and Word.
• Ability to travel domestically and internationally if necessary.
• Ability to work across global time zones (including APAC).
• Excellent written and verbal communication skills, strong organization and follow-through, sound judgment, and the ability to communicate issues and recommendations clearly.

Preferred Experience

• Early-stage immunology, autoimmune, inflammatory, allergy, or other biomarker-rich clinical development experience.
• Experience with biologics and early-phase studies; exposure to first-in-human, first-in-patient, adaptive or basket study designs, or global study execution is a plus.
• Experience performing clinical site monitoring visits, including remote visits.
• Experience working in a venture-backed biotechnology company or another lean environment where team members combine strategic thinking with hands-on execution.
• Experience supporting regulatory or ethics submissions, safety review committee logistics, and cross-functional clinical development activities.

Competencies

• Ownership and accountability for assigned deliverables, with urgency, attention to detail, and follow-through required to complete them reliably.
• Collaborative teamwork that builds trust across disciplines, invites input, and supports timely, well-informed decisions.
• Operational discipline, including working independently, accurate tracking, clear documentation, proactive follow-up, and thoughtful use of data and risk-based thinking.
• Adaptability and learning agility in the face of ambiguity, changing priorities, and the hands-on work required to support an emerging pipeline.
• Patient focus, connecting operational decisions to participant safety, data integrity, and the potential impact of Seismic’s medicines for patients.

Other

This role is based in Watertown, Massachusetts, with in-office expectations consistent with Seismic’s company policies and business needs. Domestic and international travel approximately 20–30%, based on study needs.

The annual base salary range for this position is $130,000 – $170,000 (depending on experience and level).

APPLY HERE

Seismic Therapeutic is an equal opportunity employer. We welcome applicants of every background and make employment decisions without regard to race, color, national origin, sex, sexual orientation, gender identity, religion, age, disability, veteran status, pregnancy, genetic information, or any other status protected by federal, state, or local law. If you need an accommodation during the application or interview process, please let us know.