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.
Provide sponsor oversight of CMO QC labs and maintain control strategies for investigational cell therapy products.
Manage validation of analytical methods and stability programs to support clinical trials.
Investigate laboratory deviations and ensure risks are managed to resolution.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. Guided by core values of innovation and collaboration, they are a growing company committed to transforming treatment for autoimmune disease.
Lead site activation strategies and oversee start-up activities across clinical studies.
Manage critical path plans and mitigate risks to ensure timelines are met.
Collaborate with cross-functional teams and clients to improve activation processes.
Our partner is a clinical research organization that supports the delivery of clinical trials. They are a global company with a collaborative culture focused on innovation and operational excellence.
Lead the strategy and execution of oncology site relationship development and engagement initiatives for clinical trials.
Build and strengthen long-term partnerships with key clinical research sites and networks using data-driven approaches.
Collaborate with cross-functional teams to incorporate site insights into trial strategies and present engagement plans during client meetings.
Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. They process applications and share shortlists with employers, focusing on efficient and objective recruitment.
Provide program management expertise and leadership for novel engineered T cell therapies, managing cross-functional development programs.
Drive execution against critical path activities, track milestones, and communicate risks to senior leadership.
Influence cross-functional stakeholders to align on priorities, resolve conflicts, and support governance forums.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. It is a rapidly growing company driven by core values of innovation and collaboration.
Drive strategic account leadership within key community oncology accounts, collaborating with cross-functional teams to develop and execute business strategies.
Manage contracting and access strategy, including negotiations and performance reviews to ensure provider-level access for CAR-T therapies.
Provide education and advocacy to P&T formulary decision makers, and engage with community-focused stakeholders to support Kite's strategic imperatives.
Kite is a biopharmaceutical company developing innovative cancer immunotherapies, specifically CAR-T cell therapies. As a subsidiary of Gilead Sciences, we are driven by the singular goal of curing cancer, fostering an inclusive and diverse culture.
Create and execute clinical operational strategic plans aligned with product strategy and resource allocation.
Build, develop, and train internal staff and external vendors to enhance efficiency and engagement.
Oversee relationships with Contract Research Organizations, vendors, and investigative sites to ensure compliance with FDA and ICH GCP guidelines.
Lycia Therapeutics is a biotechnology company using its proprietary LYTAC platform to develop therapeutics that degrade extracellular and membrane-bound proteins. Founded in 2019, the company has raised $75 million in Series D financing and is headquartered in South San Francisco.
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.
Build and lead the US Field Medical Affairs organization, including hiring and managing a high-performing MSL team.
Implement field strategy in alignment with clinical development and launch plans, and oversee MSL training and analytics.
Collaborate internally and externally, track KPIs, and ensure compliance with regulations while engaging key opinion leaders.
The job posting states: 'Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.'
Serve as the primary point of contact and partner with investigative sites to ensure high-quality clinical trial conduct.
Conduct site evaluation, training, monitoring, and closure activities in compliance with regulations, GCPs, and SOPs.
Utilize risk-based monitoring and site engagement strategies to improve data integrity, compliance, and study performance.
AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, neuroscience, and aesthetics. A large global biopharmaceutical company, AbbVie fosters a culture of innovation and integrity to transform patients' lives.
Build and lead a best-in-class specialty sales organization for CAR-T therapies in autoimmune diseases.
Develop go-to-market strategy, drive revenue growth, and ensure compliance with regulatory requirements.
Collaborate cross-functionally to optimize treatment center activation, patient access, and therapy adoption.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by core values, they are committed to transforming the future of treatment for autoimmune disease.
Own payer access and coverage strategy for national and regional commercial payers, PBMs, and IDNs.
Lead value-based discussions with medical and pharmacy directors to drive timely medical policy positions.
Navigate buy-and-bill, medical-benefit, and specialty-pharmacy access pathways for infused cell therapies.
Capricor Therapeutics is a biotechnology company advancing cell and exosome-based therapies for rare diseases, with a lead cell therapy for Duchenne muscular dystrophy. The company is a publicly traded, pre-commercial organization with a focus on scientific rigor, collaboration, and patient impact.
Execute and support the thought leader engagement strategy for the platinum resistant ovarian cancer asset ELAHERE.
Build long-term relationships with national/regional HCPs to support strategic engagement objectives and foster collaboration.
Oversee regional speaker programs, coordinate TL engagements at medical conferences, and collaborate with cross-functional teams.
AbbVie discovers and delivers innovative medicines and solutions for serious health issues in immunology, oncology, neuroscience, and aesthetics. It is a large global biopharmaceutical company with a culture focused on making a remarkable impact on patients' lives.
Manage end-to-end patient cases for TIL therapy from referral through post-infusion, serving as a primary contact and trusted advisor.
Collaborate with treatment centers, interdisciplinary care teams, and internal partners to coordinate tumor procurement, manufacturing, and time-sensitive milestones.
Identify and resolve barriers to therapy access, track critical milestones, and contribute to continuous improvement and site onboarding best practices.
Iovance Biotherapeutics is a global leader in developing tumor infiltrating lymphocyte (TIL) therapy for cancer, pioneering a transformational approach that harnesses the immune system to attack tumors. The company is committed to continuous innovation in cell therapy, including gene-edited options, and fosters a diverse, inclusive culture.
Serves as clinical trial lead, overseeing study planning, conduct, and oversight per protocol and regulations.
Develops study documents, manages site feasibility, and drives recruitment strategies.
Leads internal clinical team meetings and ensures quality deliverables through metric reporting.
Precision Medicine Group is a life sciences company that supports clinical research and development. The company is large enough to offer a range of benefits and emphasizes a collaborative, ethical culture focused on quality and compliance.
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.
Acts as primary point of contact for investigative sites, providing training and support to ensure compliance with protocols and regulations.
Conducts site evaluation, monitoring, and closure activities while managing recruitment and retention plans based on patient journey.
Collaborates with central monitoring to assess risks and ensure data quality, safety reporting, and audit readiness at assigned sites.
AbbVie discovers and delivers innovative medicines and solutions addressing serious health issues in immunology, oncology, and neuroscience. It is a large pharmaceutical company with a global presence and a culture focused on remarkable impact.
Independently manage all operational aspects of Phase I clinical trials from startup through closeout, ensuring adherence to protocols and regulations.
Oversee CROs and vendors to ensure alignment with study goals, budget, and timelines.
Lead the company-wide rollout of Veeva Vault, serving as a primary operational user and subject matter resource.
Absci is a clinical-stage biotechnology company leveraging generative AI for drug discovery through its Integrated Drug Creation platform. The company has a global presence with offices in the US, Switzerland, and Serbia, and fosters a collaborative, innovative culture.
Manage the identification, outreach, and onboarding of high-performing clinical sites into the North America ASN.
Develop strong relationships with high-priority sites and partners to expand the site network.
Build innovative solutions to grow a pipeline of high-potential sites and enhance clinical trial delivery.
Alimentiv is a clinical research organization that drives clinical trial delivery through site network management. They are a global company with a focus on operational excellence and innovation.
Own and shape a regional start-up function, building scalable systems and playbooks for site activation across Central/Eastern Europe and Georgia.
Drive site identification, feasibility, and readiness from CDA through activation, collaborating with sites, CROs, and sponsors.
Monitor cycle times and use data to proactively identify bottlenecks and improve activation timelines.
Iterative Health is a healthcare technology and services company that accelerates clinical research to transform patient outcomes, specializing in gastrointestinal, hepatology, obesity, and cardiology. With 250+ employees worldwide, the company fosters a collaborative, low-ego culture focused on high ownership and accountability.