Serve as the clinical lead for one or more clinical programs, with responsibility for clinical trial design, execution oversight, and delivery of key milestones.
Serve as medical monitor for assigned studies, including review of eligibility, protocol deviations, safety signals, SAEs/AEs, and benefit-risk assessments.
Contribute to global regulatory strategy and interactions with health authorities (FDA, EMA, PMDA, etc.).
Lead development of phase-appropriate formulations and manufacturing processes for solid oral dosage forms.
Oversee technology transfer from development to clinical and commercial manufacturing.
Manage CDMOs, including selection, oversight, and performance management.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. They are a fully remote company headquartered in Radnor, Pennsylvania.
Supports the development and execution of global regulatory strategy.
Maintains relationships with relevant regulatory agencies.
Identifies risks and interpret and communicate relevant issues to project team members and senior management.
Iovance Biotherapeutics aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. It is committed to continuous innovation in cell therapy, with a diverse and inclusive work environment.
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.
Assist Clinical Project Manager in the development and management of company-sponsored global clinical trials.
Provide support in site recruitment, site initiation, site payments and site close-out.
Help to provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.
ImmunityBio, Inc. is a commercial-stage biotechnology company that develops cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system. The company is publicly traded with headquarters in Southern California, offering a collaborative environment with professional development opportunities.
Serve as the global leader for Immunovant product safety.
Provide strategic vision and operational oversight across all aspects of drug safety.
Lead all pre- and post-marketing safety, PV and risk management activities.
Immunovant is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.
Independently oversees all aspects of study site management to ensure patient safety is protected.
Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits.
Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision's high quality and professional image.
Precision Medicine Group is expanding its capabilities across Latin America. They are an Equal Opportunity Employer, with employment decisions made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
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.
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.
Serve as a clinical science representative on global development teams.
Provide therapy‑area medical and scientific expertise in the evaluation and presentation of clinical trial data.
Contribute to a culture of innovation, collaboration, and continuous improvement.
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, searching for high-impact individuals.
Monitor and own the progress of clinical studies at investigative sites.
Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
Coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. They have a strong focus on Oncology and Rare Disease and passionate about cultivating their culture with high CRA retention rates.
Define and communicate a clear medical vision that aligns clinical opportunities with the company’s mission and commercial strategy.
Identify and prioritize clinical unmet needs with the greatest potential for patient benefit and market impact.
Serve as the primary medical spokesperson for the company with internal teams, investors, collaborators, and the broader oncology community.
Artera is a precision medicine company developing AI tests to personalize cancer therapy. Artera offers an AI-enabled test that provides both predictive and prognostic results for patients with localized prostate cancer.
Supports analytical development and characterization activities for late-stage biologic development leading to licensure application submission.
Takes a leading role in analytical characterization activities in support of comparability studies, heightened characterization studies, method development, control strategy development.
Supports preparation of regulatory submissions and regulatory engagement as technical subject matter expert as needed.
Akero Therapeutics, a Novo Nordisk company, is focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. They are a team of problem solvers dedicated to pursuing bold scientific approaches and have a collaborative spirit, breeding a culture where everyone feels inspired.
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.
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.
Management and operational delivery of clinical elements within a trial.
Successful execution of assigned trials and ensuring completion of deliverables.
Identify challenges to study timelines and offer creative action plans.
Precision for Medicine is a precision medicine CRO, integrating novel clinical trial designs, operational and medical experts, and biomarker and data analytics solutions. They are passionate about rare diseases and oncology, working across other therapeutic areas, with high-energy, dedicated professionals.
Responsible for executing clinical studies in compliance with quality standards.
Supports the Study Project Manager in leading the cross functional study team.
Supports the development of the clinical study blueprint/protocol and associated systems and documents.
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. They strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience.
Serve as Study Biostatistician for assigned clinical trials to provide statistical support from design, analysis to reporting
Collaborate with cross-functional experts on clinical trial designs and make contributions to determination of objectives, endpoints and sample size
Conduct data analyses as needed by using own SAS programs in collaboration with internal Statistical Programming team
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 to strengthen their patient-centric team.
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”.