Support site initiation, management, and close-out activities.
Ensure trial conduct complies with protocol and regulatory requirements.
Participate in data review and support site readiness.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are committed to transforming the future of treatment for autoimmune disease by staying true to their values and innovating boldly.
Designs and aligns operational plans to study and company objectives; balances short-term needs with long-term goals
Provide overall management of day-to-day operations of assigned study (ies) to ensure completion per established program goals
Lead cross-functional teams and ensure vendors are compliant with contracted scope of work
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. The company's work culture is a hybrid model with 2 days/week in the New York City office and 3 days working from home.
Lead end-to-end biosample and biomarker operations for Phase 1 SAD/MAD and Phase 2 clinical studies, as well as earlier-stage translational work.
Develop reusable SOPs, tracking tools, and reconciliation workflows to scale operations across the portfolio.
Proactively manage risks and maintain tight coordination across R&D, CMC, and external partners.
Enveda is reinventing drug discovery by harnessing nature’s intelligence. They are a unicorn status company with an award-winning culture, and their success is driven by the extraordinary team turning their mission into reality every day.
Identify operational efficiencies for Apogee in partnership with key CROs and vendors and implement solutions to support delivery of Clinical Trial Operations team.
Partner with key stakeholders including Clinical Trial Operations, Vendor and Strategic Management to ensure vendor performance aligned with Apogee expectation.
Proactively identify and maintain standards to ensure consistency across all programs and studies for operationalizing global clinical trials working with assigned CRO’s.
Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets. They have a fast-paced company culture, founded on their C.O.R.E. values: Caring, Original, Resilient and Egoless and a commitment to refusing to stop at “good enough”.
Act as a central contact for Clinical Study Teams for TMF management and participate in the development of quality oversight processes for TMF management of clinical trials.
Review and approve TMF documents, co-author and manage TMF documents such as TMF Plan and Index, and ensure quality management by reporting metrics and reconciling outstanding queries.
Oversee the activities of external vendors, ensuring study documents are adherent with ICH-GCP guidelines and regulatory requirements and that assigned studies are inspection-ready.
Oruka Therapeutics develops novel biologics designed to set a new standard for the treatment of chronic skin diseases like plaque psoriasis. It is a growing biotech startup building its core team with an engaged, inclusive, and positive company culture focused on making a difference.
Own the complete customer and patient journey from initial patient registration through legally compliant product sale and invoicing.
Design, launch, and lead a Kyverna-branded Navigator organization serving as the primary interface for CAR T treatment centers.
Define the enterprise patient support strategy and operating model.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are committed to transforming the future of treatment for autoimmune disease and redefine what’s possible.
Develop a short-term strategy for clinical and industry trials.
Oversee clinical trial operations, including regulatory compliance, budgeting, contracting, and performance metrics.
Manage and lead a team of clinical research coordinators and leaders across the health system
CommonSpirit Health is building a healthier future for all through its integrated health services. As one of the nation's largest nonprofit Catholic healthcare organizations, CommonSpirit Health delivers more than 20 million patient encounters annually and has more than 157,000 employees.
Lead the end-to-end TMF strategy, including the transition from outsourced to in-house operations.
Define and implement TMF governance, processes, and standards to ensure consistent document organization.
Serve as the TMF subject matter expert, establishing clear expectations for document structure.
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.
Draft, revise, negotiate, and manage a wide range of contracts and documents.
Work closely with various internal clients to ensure contracts accurately convey desired terms, while minimizing risk.
Ensure efficient negotiation and project management of the contract life cycle in support of Clinical Development timelines.
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.
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.