Support GCP/GCLP/GVP audits for investigational sites, internal systems, and clinical service providers, including planning, coordination, and reporting.
Assist with commercial inspections, inspection readiness activities, and GCP compliance tasks such as investigations and change controls.
Maintain a continuous improvement mindset and represent the Clinical Quality Assurance Team in cross-functional projects.
Iovance Biotherapeutics is a biotechnology company pioneering tumor infiltrating lymphocyte (TIL) therapy for cancer patients. The company is a clinical-stage organization with a strong focus on innovation and collaboration in a fast-paced environment.
Provide strategic and technical leadership for CMC activities, overseeing technology transfer, scale-up, and cGMP manufacturing for small molecule drug development.
Manage contract manufacturing organizations and author regulatory submission sections to ensure alignment and timely achievement of program milestones.
Collaborate cross-functionally with Quality, Regulatory Affairs, and Supply Chain to support clinical and commercial goals from Phase I through commercialization.
Travere Therapeutics is a biopharmaceutical company dedicated to identifying, developing, and delivering life-changing therapies for people living with rare disease. The company is a dedicated team focused on meeting the unique needs of rare patients, fostering a collaborative, diverse, and fast-paced environment centered on patients, courage, community, and collaboration.
Lead operational oversight of clinical external manufacturing for drug product, transitioning monoclonal antibodies into scalable processes.
Develop robust aseptic strategies for vial and prefilled syringe formats, managing CMOs and technology transfers.
Collaborate with formulation and device teams to create stable high-concentration liquid formulations and troubleshoot manufacturing issues.
We develop potentially best-in-class therapies for patients with severe autoimmune diseases. Our lead antibody, claseprubart, is engineered for extended half-life and improved potency, and we are building a culture centered on core principles to elevate patient care.
Provide strategic regulatory leadership for cell therapy portfolio including commercial readiness and labeling.
Lead global health authority interactions including FDA, EMA, and negotiations for labeling and approvals.
Oversee submissions, mentor a high-performing team, and align regulatory strategy with business objectives.
Kyverna is a biotechnology company developing autoimmune cell therapies. As a late-stage organization, it fosters a collaborative culture in a fast-paced, high-growth environment.
Oversee CDM operations including CRF/eCRF design, validation programming, discrepancy management, and database development/production with a focus on quality and compliance.
Provide oversight of CROs, vendors, and internal teams, recruiting and leading CDM staff to meet clinical trial timelines and budgets.
Partner cross-functionally on data management issues, identify risks, and propose solutions to ensure inspection-ready, high-quality data.
Definium Therapeutics is a late-stage clinical biopharmaceutical company applying scientific rigor to psychedelics to develop accessible treatments for psychiatric and neurological disorders. Headquartered in New York and traded on Nasdaq (DFTX), the company is advancing a new generation of therapeutics with a focus on turning evidence into impact.
Lead the Manufacturing and Supply Chain function, partnering with external providers and internalizing capabilities to advance the pipeline.
Evaluate, source, and manage contract manufacturers and supply organizations for autologous and allogeneic CAR T therapies globally.
Manage clinical supply, materials management, and strategic sourcing while ensuring network readiness for pivotal studies and commercial launch.
Kyverna is a cell therapy company engineering and developing curative living medicines for inflammatory and autoimmune diseases. The company is building on oncology CAR T technology and values intellectual humility, elevating each other, and staying true to why.
Build, maintain, and continuously improve the company's Quality Management System (QMS) and oversee GxP CSV requirements.
Own the design and administration of the electronic QMS, including validation, document control, and compliance activities.
Lead internal audit and inspection-readiness programs, supporting regulatory inspections and promoting a culture of quality.
Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs, targeting the underlying drivers of aging to delay disease and preserve quality of life. As a well-funded startup with teams of scientists, veterinarians, engineers, and creatives, it is pioneering the first FDA-approved lifespan extension medicine.
Lead global regulatory strategy for one or more drug development programs, with emphasis on submissions and health authority interactions.
Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments, ensuring high-quality documents.
Collaborate with cross-functional teams to create and negotiate clinical-regulatory development paths and prepare for health authority meetings.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.
Lead and manage all drug safety functions for investigational products across the organization.
Oversee pharmacovigilance activities, vendor management, and regulatory submissions.
Collaborate cross-functionally to ensure compliance and advance patient safety.
BridgeBio pioneered a 'moneyball for biotech' approach, pooling projects and early-stage research to reduce risk and accelerate innovation. The company focuses on rare diseases with small expert teams and a culture of curiosity and ethical AI use.
Provide study oversight as primary liaison between CRAs, internal staff, site staff, client personnel, and external vendors.
Ensure clinical monitoring activities comply with SOPs, regulations, GCP, KPIs, and study-specific requirements.
Develop and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996, supporting research behind innovative treatments in pharmaceutical, biotech, and medical device industries. They foster a collaborative community where team members feel valued, supported, and empowered to make a meaningful impact on global health.
Ensure product claims, labeling, and regulatory documentation meet FDA and FTC requirements for dietary supplements.
Work cross-functionally with Brand, Product, Quality, and Marketing teams to translate regulatory frameworks into actionable guidance.
Support GMP compliance, audits, and process improvements to strengthen regulatory operations at scale.
The company is a partner organization managing applications and next steps for a role in consumer health. They are a science-led organization with a growing portfolio of microbiome and nutrition-focused innovations.
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
Collaborating with investigators and site staff to facilitate smooth study conduct.
ICON is a global healthcare intelligence and clinical research organization dedicated to accelerating the development of new medicines and treatments. As a values-driven company, ICON fosters a culture of integrity, collaboration, agility, and inclusion, employing a diverse workforce.
Oversee sterilization processes within medical devices and provide technical support across all certification schemes as a fully remote role.
Lead a team of MDR Product Assessors-Sterilization, manage resource planning, and drive team performance against global targets.
Develop and maintain sterilization QMS documentation aligned with best practices and applicable regulatory requirements.
SGS is the world's leading testing, inspection and certification company, recognized as a global benchmark for sustainability, quality, and integrity. With 99,600 employees operating a network of 2,600 offices and laboratories, we offer a dynamic, international work environment with a focus on professional development and sustainability.
Drive regulatory strategies for Expanded Access Programs across global markets, ensuring compliance and patient access.
Act as a subject matter expert in communications with pharmaceutical clients, health authorities, and cross-functional teams.
Prepare and submit regulatory dossiers while maintaining up-to-date knowledge of global frameworks.
Jobgether uses AI-powered matching to connect candidates with jobs at partner companies. They are a fast-growing global organization with a dynamic scale-up environment and high autonomy.
Own Cadence's QMS strategy and regulatory operating model for AI-enabled healthcare software, SaMD, and technology-enabled care workflows.
Lead quality system governance across design controls, risk management, CAPA, change control, document control, training, and audit readiness.
Partner with Product, Engineering, and Clinical teams to assess regulatory pathway, device classification, and QMS requirements for new software capabilities.
Cadence is a clinical AI company that delivers continuous, proactive care for older adults with chronic conditions. They operate as a full clinical care delivery organization with clinicians working alongside health system partners, helping Medicare save $2M a week.
Lead integrated drug development strategies across preclinical, clinical, regulatory, and commercial dimensions for pharmaceutical and biotech programs.
Provide expert guidance on clinical development plans, target product profiles, study designs, and regulatory submission strategies.
Engage with global regulatory authorities and support portfolio management, licensing, and business development decisions.
Jobgether uses AI-powered matching to connect candidates with hiring companies. They process applications efficiently and share shortlists with employers, supporting a global, inclusive work environment focused on innovation.
Drive growth of Regulatory Science and Medical Writing services across pharmaceutical, biotechnology, and life sciences clients.
Lead strategic sales efforts, identify client needs, and partner cross-functionally to deliver tailored solutions supporting regulatory approvals.
Serve as the primary liaison between client and company for all sales-related activities, enhancing visibility and market presence.
Veristat accelerates life-changing therapies to patients worldwide with more than 30 years of expertise. They have a flexible, inclusive culture with 70% remote workforce and 66% women-led teams, having prepared over 105 approved therapies and delivered over 350 rare disease projects.
Serve as a subject matter expert for site management and monitoring strategies across complex clinical studies.
Collaborate with clinical teams, investigators, and stakeholders to ensure compliance, data quality, and trial success.
Mentor CRA staff, resolve escalated issues, and support site qualification, initiation, monitoring, and close-out visits.
Jobgether is a platform that uses AI-powered matching to connect candidates with job opportunities. They operate as a global healthcare and technology environment, offering professional growth and innovative solutions.
BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines for genetic diseases and cancers with clear genetic drivers. Founded in 2015, the company has a portfolio of 20+ drug development programs and offices in the US, Canada, and Switzerland, focusing on scientific excellence and rapid execution.