Hold a leadership role within the study team, overseeing and guiding clinical trial activities at a country or regional level.
Ensure high-quality execution, compliance, and timely delivery while acting as a key coordination point across cross-functional teams.
Focus on leadership, mentorship, and remote oversight of monitoring practices with minimal to no site assignments and a low-travel model.
PSI is a leading Contract Research Organization focusing on delivering quality and on-time clinical trial services across various therapeutic areas. With over 25 years in the industry, it offers a balance of stability and innovation, fostering a dynamic team environment.
Support operational execution of cell therapy clinical trials with a focus on vendor management and central laboratory oversight.
Ensure vendors deliver high-quality, timely services aligned with study timelines, budgets, and regulatory requirements.
Oversee site feasibility, selection, contracting, start-up, and close-out activities to support study milestones and program objectives.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by core values of collaboration, clarity, innovation, and ownership, the team is committed to transforming the future of treatment for autoimmune disease.
Review and approve post-marketing Individual Case Safety Reports and Serious Adverse Event reports for medical assessment, including coding and causality.
Support signal detection activities, review aggregate reports like PBRERs and DSURs, and provide input for Risk Management Plans and regulatory responses.
Utilize advanced English and Japanese language skills to collaborate cross-culturally with global teams and clients, ensuring high-quality pharmacovigilance services.
PrimeVigilance is a specialized pharmacovigilance service provider offering support in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance to pharmaceutical and biotechnology partners globally. It is a mid-size company that values employee training, well-being, and a healthy work-life balance, fostering a collaborative, human-centric environment with team members across continents.
Develop and author Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) per EU MDR to support regulatory submissions for CE Mark.
Conduct comprehensive literature searches, review scientific data, and critically appraise literature to support clinical evaluations and risk assessments.
Manage CEP/CER timelines using project management tools and serve as a subject matter expert for R&D and broader Clinical/Medical Affairs activities.
Intuitive is a pioneer and market leader in robotic-assisted surgery, focused on expanding the potential of physicians through minimally invasive care and intelligent technology. The company fosters an inclusive and diverse team of passionate people grounded in integrity, with a strong capacity to learn and the energy to get things done, actively investing in long-term team member growth.
Identify and manage changes to medical rules by reviewing policies, transmittals, and bulletins for revision, retirement, or addition.
Build and maintain Clinical Transaction Engine tables, assign CPT/HCPCS codes, and review national policies for integration into medical edits.
Independently prepare data editorials for production release, analyze coding trends, and resolve client issues forwarded by Compliance Support.
Experian is a global data and technology company that powers opportunities for people and businesses by redefining lending, preventing fraud, simplifying healthcare, and creating digital marketing solutions. With over 23,300 employees across 32 countries, it's a FTSE 100 company known for its innovative, people-first culture focused on inclusion and development.
Support maintenance and execution of global publication plans and manage end-to-end activities for manuscripts, abstracts, and posters.
Support planning and execution of key scientific congresses and medical meetings, including logistics coordination and vendor management.
Ensure compliance with internal policies and external publication guidelines while proactively communicating with publication leads and external authors.
Kyverna Therapeutics is a biotech company developing therapies for autoimmune diseases. The company operates in a fast-paced clinical environment with a focus on cross-functional collaboration in medical affairs.
Develop and translate economic evidence into value-based messaging for payer and formulary decision makers.
Build and drive the US value proposition story for approved and pipeline cancer therapies, incorporating health economic impact.
Direct strategy for formulary submission packages, economic models, and provide pharmacoeconomic expertise to cross-functional teams.
Iovance Biotherapeutics is a biotechnology company pioneering tumor infiltrating lymphocyte (TIL) therapy for treating cancer. The company operates in a dynamic, innovative environment focused on cell therapy development and commercialization.
Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting for over 35 trials per year.
Serve as the internal project manager for assigned oncology disease groups, providing timely updates on submission status and regulatory guidance on study development.
Act as the liaison between sponsors, investigators, Winship, Emory IRBs, external IRBs, and internal departments, ensuring all facets of each protocol are compliant.
Emory University is a leading research university that fosters excellence and attracts world-class talent. Winship Cancer Institute of Emory University is Georgia's only National Cancer Institute-designated Comprehensive Cancer Center dedicated to discovering cures for cancer and providing innovative therapies and clinical trials.
Define and lead the Regulatory strategy for early-stage gene therapy programs (pre-IND through Phase 1/2).
Lead preparation for and participation in global health authority interactions, including FDA (CBER), EMA, and other regional agencies.
Proactively identify and communicate potential risks and define mitigation strategies.
Lexeo Therapeutics is a clinical-stage genetic medicine company headquartered in New York City, pioneering cardiac genetic medicine candidates to treat the root causes of inherited cardiovascular diseases. Their work culture is a hybrid model with 2 days/week in the New York City office and 3 days working from home.
Lead and execute internal audits across GMP, GCP, and GPV systems.
Conduct GxP audits in accordance with applicable regulatory requirements.
Oversee the GxP vendor and supplier management program.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, we are committed to transforming the future of treatment for autoimmune disease.