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”.
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.
Responsibility for day-to-day activities within a region or regions, including site selection, start-up, maintenance, and close-out activities.
Serve as the key operational contact for Braveheart Bio studies aiding in site selection, study implementation, and ongoing coordination of study sites, either directly or via CROs.
Proactively identify potential operational challenges and, in collaboration with senior team members, provide solutions to ensure study execution remains on track.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a rapidly evolving therapeutic area.
Serve as leader of the local study team on assigned studies.
Manage and maintain accurate country level plans including timelines and budgets.
Implement startup and site activation plans at various levels.
Jobgether uses an AI-powered matching process to ensure applications are reviewed quickly, objectively, and fairly. They identify top-fitting candidates and shares this shortlist directly with the hiring company.
Guide field CRM implementation and maintenance with CRM implementation vendor.
Manage field alignment including field roster, zip to terr, HCO/HCP targeting and alignment.
Coordinate/manage sample operations and logistics with sampling vendor and field colleagues.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. They are headquartered in Radnor, Pennsylvania and are a fully remote company.
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.
Responsible for operational oversight of the site, site health and monitoring activities.
Support sites in understanding study expectations, timelines, and required deliverables.
Build and maintain strong, trusted relationships with investigators and site staff.
CSL Behring is a global biotherapeutics leader committed to saving lives. They focus on serving patients’ needs by using the latest technologies to discover, develop, and deliver innovative therapies. CSL's parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries.
Responsible for the strategic oversight, operational management, and continuous improvement of the Trial Master File (TMF).
Lead TMF quality review activities, including ongoing completeness checks ensuring that all required documents are accurately filed.
Identify eTMF trends and commonly misfiled documents, and lead efforts to identify, communicate, and resolve document inconsistencies.
Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Founded in 2019, they are continuously expanding their presence and global footprint and searching for high-impact individuals.
Responsible for compliance with regulatory and ICH guidelines, GCPs, company guidelines and Standard Operating Procedures, and CDM best practices.
Independently leads EDC development, including CRF development, EDC specification process, edit check development and User Acceptance Testing.
Effectively oversees contracted vendors to ensure data are complete, accurate and delivered within agreed on timelines.
Adverum Biotechnologies, Inc., a wholly owned subsidiary of Eli Lilly and Company, develops gene therapy as a new standard of care for ocular diseases. They are a clinical-stage company aiming to deliver therapies in physicians’ offices to eliminate the need for frequent ocular injections.
Initiate and scale a new CLIA high-complexity laboratory performing an FDA-approved early cancer detection test.
Provide operational and strategic leadership for the colorectal cancer screening assay within the clinical laboratory.
Establish the technical, operational, and cultural foundation of the laboratory.
Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health, aiming to make personalized genetic testing and diagnostics part of the standard of care. The Natera team consists of statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions.
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.
Maintain project documentation including presentations, plans, agendas and overall project timelines.
Act as the primary liaison between technical teams and external partners to ensure alignment on project goals.
Provide proactive communication by setting clear expectations and providing project updates before client requests.
Medrio seeks smart and capable individuals to expand product capabilities, grow their business, and better serve customers. They value collaboration, ingenuity and creating a culture of excellence, offer great benefits and promote an atmosphere of work/life balance, including flexible work schedules and locations.
Provide strategic and administrative leadership for clinical research business and operational activities.
Ensure studies are conducted in accordance with regulatory requirements and sponsor expectations.
Drive operational performance, program growth, and team development across the clinical research enterprise.
Florida Cancer Specialists & Research Institute (FCS) has built a national reputation for excellence since 1984. With over 250 physicians, 220 nurse practitioners and physician assistants and nearly 100 locations, they utilize innovative clinical research, cutting-edge technologies, and advanced treatments.