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 the clinical roadmap from early feasibility through reimbursement and shape the scientific narrative for a new class of psychiatric therapy.
Oversee active clinical studies and grant-funded programs to ensure timely and budget-conscious delivery.
Represent the company at scientific meetings and build relationships with key opinion leaders in psychiatry and neuromodulation.
Motif is a medical device startup designing and developing minimally invasive electronic solutions for serious mental health conditions. It is an early-stage startup with a highly dedicated team passionate about neurotechnology and patient-first culture.
Lead participatory research and co-design projects with partner organizations to develop AI Civics toolkits and training resources.
Steward relationships with national partners in K-12 education, labor, faith, or advocacy sectors.
Produce case studies, reports, and academic publications to advance public understanding of AI governance.
Data & Society is an independent nonprofit research organization studying the social implications of data-centric technologies and automation. It is a small to medium-sized organization that values empirical evidence and respect for human dignity, with a collaborative culture focused on inclusive engagement and anti-racist practices.
Lead design and execution of clinical trials for novel antibody-based therapies in rheumatology and I&I diseases.
Collaborate cross-functionally with clinical operations, regulatory, translational science to ensure robust study designs and data quality.
Interpret clinical data and present findings internally and externally, supporting regulatory submissions and scientific publications.
Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation therapies for immunology diseases. As a small, young company, it fosters a fast-paced, collaborative culture focused on advancing meaningful medicines for patients.
Perform all aspects of clinical site monitoring, including routine, initiation, and close-out visits.
Ensure patient safety and data integrity by verifying informed consent and protocol adherence.
Manage site communications, complete SAE reporting, and assist with new employee training.
Fortrea is a clinical research organization that helps biopharmaceutical and medical device companies bring life-saving therapies to patients. The company emphasizes a collaborative, family-oriented culture with a focus on teamwork and excellence, employing a large workforce globally.
Lead the design, analysis, and interpretation of clinical studies for rare disease and oncology trials.
Oversee all contracted statistical activities, including protocol development, statistical analysis plans, and data review.
Provide mentorship to junior statisticians and represent the biostatistics function in cross-functional meetings and audits.
Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. With a global team across five continents, they value teamwork, flexibility, and work-life balance.
Engage with healthcare professionals to exchange clinical, scientific, and research knowledge in alignment with regulatory guidelines.
Provide educational, scientific, and research support for Sobi's rare-disease product portfolio within the rheumatology franchise.
Serve as a field-based scientific expert, build relationships with key thought leaders, and support clinical development activities.
Sobi is a specialized biopharmaceutical company dedicated to developing and delivering innovative therapies for people with rare diseases. With over 1,900 employees in more than 30 countries, we foster a collaborative and inclusive culture that empowers employees to make a difference.
Interpret clinical diagnostic testing results and apply variant classification guidelines to meet quality and turnaround time requirements.
Review and summarize relevant medical literature and clinical information for accurate report generation.
Work towards expertise in clinical and technical aspects, attending trainings and becoming proficient in IT systems.
Ambry Genetics is a genetics-based healthcare company dedicated to open scientific exchange to understand and treat all human disease faster. They are a CAP-accredited and CLIA-licensed molecular genetics laboratory based in Aliso Viejo, California, with a collaborative culture that values learning and open exchange.
Provide statistical leadership across clinical research projects, ensuring high-quality methodologies and analyses.
Collaborate with cross-functional teams to support innovative study designs and advanced statistical modeling.
Author and review Statistical Analysis Plans (SAPs), tables, listings, and figures for regulatory submissions.
The partner company provides advanced statistical expertise and scientific leadership within a collaborative biometrics and data science environment, supporting complex clinical research projects across multiple therapeutic areas. The company fosters a collaborative and supportive culture focused on technical excellence and innovation, with a team of experienced professionals.
Manage data management vendors, ensuring quality through audits and key performance metrics.
Develop program-level DM deliverable timelines and drive internal/external negotiations.
Represent data management at cross-functional meetings, providing study status updates and escalating issues.
Ultragenyx is a biopharmaceutical company focused on developing treatments for rare diseases by challenging the status quo and applying a novel rapid development approach. The company fosters a supportive and inclusive culture of learning and growth, aiming to be an organization where employees can thrive.