Review clinical trial synopses to understand IMP supply and demand requirements and assist in packaging and supply strategy development.
Coordinate with third-party vendors including packaging suppliers, distributors, and couriers to support domestic and international logistics.
Monitor inventory levels at depots and clinical sites, support regulatory inspections, and participate in cross-functional teams for continuous improvement.
Support the development and management of customized supply chain solutions using the existing database of global partners and the AI Community.
Collaborate with internal teams, ensuring all information remains accurate and up to date.
Build and maintain positive working relationships with internal stakeholders and suppliers supporting assigned programs.
RWS unlocks global understanding by valuing every language and culture. They offer access to the world’s largest linguistic network, with over 1,600 in-house translators and 29,000 freelance specialists, providing 24/7 service in over 80 countries.
Develops/maintains project timeline inclusive of startup through completion.
Drives development, approval, and distribution of study-related documents and study tools.
Manages distribution, collection and tracking of regulatory documentation.
Penumbra, Inc. is a global healthcare company focused on innovative therapies. They design, develop, manufacture, and markets novel products and has a broad portfolio that addresses challenging medical conditions.
Review purchase order and invoice discrepancies to ensure timely vendor payments and accurate accounting processes
Support warehouse operations and implementation efforts by providing recommendations that help achieve on-time delivery and inventory fill rate targets
Monitor warehouse management systems to maintain inventory accuracy, product integrity and reconciliation.
Sandbox VR is the most advanced virtual reality experience in the world, bringing people closer together through immersive experiences. As they expand globally, they value humility and have built a collaborative environment.
Set up, maintain, reconcile, and archive electronic and paper Trial Master Files
Track study status, enrollment, regulatory documentation, laboratory samples, and site start-up status for assigned clinical projects
Actively order and maintain ancillary clinical study supplies required for the conduct of clinical studies
Vedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company’s pipeline has been built using the company’s industry-leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks.
Dragos relentlessly defends industrial organizations with technology, threat intelligence, and services to protect their systems. They are a remote-first culture with operations in North America, Europe, the Middle East, and APAC, valuing authenticity, transparency, and trust.
Provides strategic leadership for Energy Vault’s end-to-end logistics function, impacting delivery execution and cost efficiency.
Builds and manages critical partner relationships across the logistics ecosystem, providing guidance on import/export regulations.
Recommends sourcing and inventory strategies, advises product design teams, and partners with executive leadership on risk and capital spend.
Energy Vault is a global energy storage and power infrastructure company focused on owning, operating, and enabling resilient, dispatchable energy assets. The company operates globally, with headquarters in Westlake Village, California and Lugano, Switzerland.
Serve as a regulatory representative on multidisciplinary program teams, supporting health authority interactions and global submissions for biologics in development.
Contribute to regulatory plans across the product lifecycle, from early clinical development through registration and lifecycle management.
Manage submission activities including INDs/CTAs, amendments, annual reports, and briefing documents, ensuring compliance with US/EU regulations and ICH guidelines.
Oruka Therapeutics (Nasdaq: ORKA) develops novel biologics to treat chronic skin diseases like plaque psoriasis, aiming for high rates of complete clearance with dosing as infrequently as once or twice per year. As a small startup building its core team, we seek top talent passionate about making a difference and contributing to an engaged, inclusive, and positive company culture.
Partner with Clinical Operations leadership to support clinical trial execution.
Lead site feasibility, selection, initiation, and greenlight activities for clinical trial sites.
Provide guidance and oversight to CRAs, including trip report review and training support.
Immatics is dedicated to making a significant difference in the lives of cancer patients. They are a global frontrunner in precision targeting of PRAME, found in over 50 cancers, with cutting-edge science and a strong clinical pipeline.
Lead day-to-day oversight of commercial manufacturing operations, process engineering activities, and continuous improvement initiatives.
Drive process optimization, troubleshooting, scale-up, PPQ, validation, and lifecycle management activities for commercial products.
Support regulatory CMC strategy, including development and review of Module 3 CTD submissions and health authority responses.
Deciphera Pharmaceuticals is committed to improve the lives of people with cancer. They offer a dynamic team environment and opportunities for personal and professional growth.
Lead and oversee clinical monitoring activities for Phase 1–3 global trials.
Establish CRO oversight, manage vendor performance, and ensure compliance with ICH-GCP.
Build scalable monitoring infrastructure, develop SOPs, and drive continuous improvement.
Oruka Therapeutics develops novel biologics for chronic skin diseases like plaque psoriasis. They are an emerging biotech company building a core team with a focus on establishing an engaged, inclusive, and positive culture.
Assist in the ongoing development, implementation, and maintenance of the Company’s compliance program.
Develop policies and procedures that provide appropriate guidance and instruction to Company employees.
Lead the development and delivery of compliance training programs for employees at all levels.
Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies. They aim to provide significantly better survival rates with dramatically fewer risks. They have a start-up culture of camaraderie and leadership by example.
Provide GMP quality oversight for outsourced manufacturing across cell bank, drug substance, drug product, packaging, labeling, and distribution.
Collaborate with cross-functional teams to ensure timely batch disposition, compliant documentation, and proactive quality risk management.
Lead quality record review, manage CDMO relationships, and support regulatory inspections and filings.
Jade Biosciences is a clinical-stage biotechnology company developing best-in-class therapies for autoimmune diseases. As a company launched from Paragon Therapeutics, it is in early clinical and preclinical stages with a focused pipeline.
Oversee inventory accuracy and reconciliation processes across all retail stores nationwide.
Analyze inventory reports to identify discrepancies, trends, and opportunities for improvement in stock accuracy.
Partner with store operations and supply chain teams to ensure accurate receiving, transfers, and returns.
Story Cannabis is a vertically integrated cannabis company, bringing hope, happiness, and healing to the world through cannabis. Founded in 2021, with locations in Arizona, Maryland, Ohio, and Louisiana, leadership defines how we show up and data drives how we grow.
Lead all project initiation and planning efforts; participate in the implementation and execution of a given project.
Closely monitor/control project progression to ensure project is completed on schedule and within budget; reports project progress to all key stakeholders.
Serves as liaison with client contacts, manages day-to-day communications and organizes project team meetings.
WuXi AppTec is a leading Contract Research and Development Manufacturing Organization (CRDMO) that provides solutions for the drug development of oligonucleotides, peptides and related synthetic conjugates. The company is an integral part of WuXi AppTec’s subsidiary WuXi STA.
Supervise and mentor a team of mobile phlebotomists, ensuring quality and compliance.
Manage logistics, including supply chain and appointment assignments, to maximize efficiency.
Handle employee grievances and customer service escalations, aiming for positive outcomes.
Getlabs is a platform for at-home diagnostics, enabling healthcare organizations to send mobile phlebotomists to patients' homes. The company has raised $50M and aims to expand access to diagnostics, fostering a dynamic and ambitious work environment.
Assist in the coordination and management of clinical trials, including study start-up, maintenance, and close-out activities.
Support Clinical Trial Managers in overseeing CRO deliverables, timelines, issue escalation, and overall study operational performance.
Maintain, organize, and update essential study documentation to ensure they are complete, accurate, and audit-ready at all times.
Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, they've built a global team of over 100 employees headquartered in Boston, with a focus on advancing their lead asset. We encourage people from all backgrounds to apply and cultivate a culture where all voices are included.
Provide daily operational and compliance support for import and export processes of traded goods.
Maintain internal controls and procedures to ensure compliance with trade regulations.
Serve as subject matter expert for general trade compliance and customs relations.
LGC Biosearch Technologies delivers mission critical genomics to its diverse customer base in molecular diagnostics, pharma/biotech, and agrigenomics. The company has manufacturing sites across the US, UK, Germany and Denmark, and plans to continue growing with a collaborative team culture.
Hold 3PL partners accountable to SLAs and KPIs, monitoring performance and tracking corrective actions.
Serve as the primary liaison between the 3PL partner and Spreetail’s central functions, translating strategic requirements into operational instructions.
Identify continuous process improvement opportunities within 3PL operations and build collaborative, solutions-focused relationships to implement effective changes.
Spreetail helps brands increase their ecommerce market share globally while improving their operational costs. They are a fast-growing ecommerce company.
Serves as direct contact between partner, PM, PMO office, Sales, Sales Operations and clients to coordinate all business requirements.
Works with Project Manager and Client Experience stocking team to manage product needs, availability and delivery.
Manages all aspects of the product delivery including tracking, scheduling deliveries and managing returns back to partner warehouse.
Connection calms the confusion of IT by guiding the connection between people and technology. The team is made stronger by a multitude of backgrounds, experiences, and perspectives, driving them to innovate and create technology solutions.
Develop, mentor, manage and coach SSU personnel to ensure quality standards.
Ensure SSU personnel work to the highest quality standards and maintain compliance.
Participate in the interview process for new SSU personnel by conducting CV review.
Precision for Medicine is a Clinical Research Organization with an integrated offering enabling the science of precision medicine. They combine clinical trial designs, operational and medical experts, biomarker and data analytics solutions, with a passion for rare diseases and oncology.