Obsidian Therapeutics

Clinical Trial Associate

• Support day-to-day clinical trial operations in alignment with protocols, timelines, and regulatory requirements.
• Serve as a point of coordination across internal teams, CROs, and external partners.
• Maintain the Trial Master File (TMF), ensuring completeness, accuracy, and audit readiness.
• Perform TMF quality control activities and proactively address gaps.
• Support audits and inspections, including preparation and follow-up activities.
• Coordinate with vendors, including central labs and specialty service providers.
• Support biospecimen tracking, logistics, and associated documentation.
• Track and monitor vendor performance and escalate issues as needed.
• Develop, maintain, and improve study tracking tools (e.g., enrollment, sample tracking, timelines).
• Ensure data accuracy and timely reporting across study activities.
• Contribute to improvements in clinical operations processes and systems.
• Facilitate clear, timely communication across study teams and stakeholders.
• Coordinate study meetings, including agenda development, minutes, and follow-up actions.
• Maintain version control and documentation across clinical materials.
• Support invoice tracking, purchase order coordination, and budget-related activities.

Clinical Trial Associate – Oncology

People Operations

• Serve as a trusted first point of contact for employees on HR processes, policies, benefits, systems, and general people-related questions.
• Ensure operational excellence. Manage and continuously improve employee lifecycle processes, including onboarding, offboarding, employee changes, employment verifications, I-9 documentation, immigration support, and personnel record maintenance.
• Own benefits administration, partnering with Director of People Operations and external vendors to ensure accurate, timely, and employee-friendly execution.
• Maintain accurate employee data and documentation across HR systems, reports, distribution lists, organization charts, compliance records, and related people operations tools.
• Coordinate required compliance training, including Code of Conduct, anti-discrimination and anti-harassment training, and future public-company readiness topics.
• Drive continuous improvement of People Operations workflows to improve consistency, scalability, documentation hygiene, and the employee experience.
• Support employee engagement, and internal community and culture initiatives, including social committee activities, DEI-related programming, and employee communications.
• Support performance management and talent processes by assisting with communications, timelines, materials, documentation, and process administration.
• Maintain job description template and library, career frameworks, competency materials, and related HR documentation and resources.
• Draft and coordinate employee communications, including intranet content, promotion announcements, company meeting materials, and other People team updates.
• Partner flexibly across the People function to support emerging priorities as the company grows and prepares for increased operational complexity.

People Operations Generalist

Director

• Lead and champion computational efforts associated with the Clinical, translational, discovery and research program efforts including analytical support for biomarker discovery and analysis to support translational and research activities.
• Identify and implement computational methodologies and datasets needed to advance discovery and programmatic activities.
• Oversee the execution of analyses for routine assays that use sequencing, array and biological data by running, maintaining, and updating analytical pipelines.
• Lead the strategic efforts related to data and analysis quality using quality-control measures, and collaborate on establishing data management practices.
• Communicate analysis results and interpretations with key stakeholders using high-quality reports in a timely manner.
• Support ad hoc statistical design and analyses for research projects and programs.
• Exercise standard code-management practices, while maintaining analytical documentation and study reports in Electronic Notebook entries.
• Collaborate effectively across Obsidian organization to support ongoing research projects and clinical program development by contributing analytical insights, requirements, workflows and presenting internally to project teams, management, and scientific teams.

Associate Director, Computational Biology – Bioinformatics

General

• Execute and support day-to-day clinical trial operations in alignment with protocols, timelines, and regulatory requirements.
• Serve as a key point of coordination across internal teams, CROs, and external partners.
• Maintain and oversee the Trial Master File (TMF), ensuring completeness, accuracy, and audit readiness.
• Lead TMF quality control activities and proactively address gaps.
• Support audits and inspections, including preparation and follow-up activities.
• Coordinate and oversee vendors, including central labs and specialty service providers.
• Manage biospecimen tracking, logistics, and associated documentation.
• Monitor vendor performance and escalate issues as needed.
• Develop, maintain, and improve study tracking tools (e.g., enrollment, sample tracking, timelines).
• Ensure data accuracy and timely reporting across study activities.
• Contribute to improvements in clinical operations processes and systems.
• Drive clear, timely communication across study teams and stakeholders.
• Plan and facilitate study meetings, including agenda development, minutes, and follow-up actions.
• Maintain version control and documentation across clinical materials.
• Support invoice tracking, purchase order coordination, and budget-related activities.

Senior Clinical Trial Associate - Oncology

Manager

• Develop proficiency in Obsidian’s drug product and drug substance manufacturing processes.
• Oversee execution of drug product and ancillary drug substance manufacturing across a network of global CDMO partners to ensure supply chain continuity and high-quality supply to the clinic.
• Manage or collaborate on CDMO investigations, MBR revisions, and change controls as needed to enable on time production and lot disposition.
• Oversee CDMO performance metrics for manufacturing and internal stakeholders demonstrating strategic areas of focus and continuous improvement opportunities.
• Contribute to cost-of-goods (COGS) optimization and value creation by leading continuous improvement initiatives with CDMO partners.
• Participate in strategic sourcing, vendor selection, capacity planning, SOW/ forecast review, and ongoing supplier relationship management for key services.
• Partner closely with Quality, MS&T, QC, CMC and Supply Chain to ensure systems are fit for purpose for program phase.
• Coach CDMOs on phase appropriate standards for operations, including scheduling, operational performance metrics, batch release, equipment maintenance, and financial reporting.
• Foster a high-performance culture with CDMO partners and internally.
• Enable team success and individual growth through clear expectations, high standards/support, stretch assignments, and coaching.

Senior Manager, External Manufacturing

Supply Chain

• Manage an End-to-End inventory management program through collaboration with external partners (Contract Manufacturing Organizations, External Biorepositories, Logistic Partners).
• Manage a detailed End-to- End MRP process including the establishment of risk-based inventory targets.
• Develop and manage a Sample inventory management program in partnership with Analytical Development and Quality Control groups.
• Support the S&OP process through End-to-End supply planning and scenario analysis.
• Support Raw Material risk assessment and Raw Material Qualification activities as part of BLA readiness activities.
• Support the establishment of a supplier management program including the development of a sourcing strategy and the establishment of Supply Agreements.
• Contribute to the development of a formal label management program.
• Develop and maintain appropriate GMP controlled documents (i.e., SOPs, WIs, and Forms).
• Manage the sourcing of Tumor Tissue to support development activities.
• Coordinate various temperature controlled non-clinical shipments of raw materials between CDMOs and storage depots to support development and clinical processes.
• Support multiple Raw Material and TIL CDMO relationships as the supply chain representative.

Supply Chain Manager, Materials Management and Planning

• Serve as the lead MSAT interface to CDMOs, providing technical oversight of clinical manufacturing
• Manage escalations through joint governance forums and collaborate with Process Development
• Define and maintain CPPs, CQAs with CDMOs
• Partner with Process Development and Analytical Development to define process characterization plans
• Define and implement a comprehensive control strategy ahead of PPQ
• Own and maintain the integrity of process monitoring databases
• Lead manufacturing campaign review processes
• Own PPQ strategy and execution
• Oversee authoring and review of batch records, validation protocols, and reports
• Drive governance of tech transfer plans, protocols, and reports
• Structure the MSAT team’s technical materials for BLA readiness
• Author and/or review relevant CMC sections of regulatory submissions
• Serve as MSAT subject matter expert in support of FDA interactions

Director, Manufacturing Science and Technology – MSAT

Therapist

• Provide strategic and operational leadership for Drug Product programs supported through external manufacturing and testing partners.
• Build systems/processes and organize resources to establish and achieve product release cycle times
• Provide QC oversight of CDMOs and contract test laboratories (CTLs)
• Direct and oversee method validation and transfer activities, including tech transfer to an external CDMO, to ensure GMP compliance
• Assist with PPQ readiness and BLA preparatory activities
• Lead QC investigation of quality events including laboratory investigations, OOS/OOT and deviations, and support manufacturing investigations at CDMOs and CTLs
• Support development of specifications for raw material, drug substance, intermediate and final product testing, and stability testing
• Author and review test methods, protocols, reports, and associated documents
• Support data trending and quality metrics
• Support regulatory submission activities
• Collaborate closely with QA, Regulatory, Supply Chain, MSAT, AD, and PD groups and external key partners
• Monitor and evaluate external laboratory performance using KPIs, driving improvements in efficiency and right-first-time execution
• Assist with continuous improvement of quality and compliance
• Regularly perform QC Person In Plant activities at Obsidian’s CDMO facilities, and other duties as needed.