Associate Director, Biomarker and Nonclinical OperationsJob SummarySeismic 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.
OtherThis 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.
