Monitor and oversee progress of clinical studies at investigative sites, ensuring compliance with protocols, SOPs, ICH-GCP, and regulations.
Coordinate study setup and monitoring activities, including investigator identification, regulatory submissions, and site initiation visits.
Identify potential study risks and propose solutions, while maintaining an impeccable eye for detail and quality outcomes.
Precision for Medicine, Oncology and Rare Disease is a precision medicine CRO that combines novel clinical trial designs, operational and medical experts, and advanced biomarker and data analytics. They pride themselves on high CRA retention rates and a culture where employees feel appreciated and have impact.
Lead the full scope of Biostatistics activities for assigned clinical programs, including study design, analysis, and regulatory submissions.
Collaborate cross-functionally with Clinical, Medical, and Regulatory teams to ensure quality and timely delivery of statistical outputs.
Oversee CROs and internal teams, supervise statistical programming, and drive continuous improvement in biostatistics processes.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. The company is headquartered in Radnor, Pennsylvania and operates as a fully remote organization.
Provide statistical oversight and lead complex programs such as NDA/BLA/MAA submissions.
Consult with clients on clinical trial study design and regulatory strategy.
Author statistical analysis plans and review statistical output for accuracy.
Precision Medicine Group provides statistical leadership and support for clinical development, consulting with clients on trial design and regulatory strategy. The company is a global organization that values collaboration, service, and accountability, fostering a culture of mentoring and innovation.
Provide scientific and strategic DMPK guidance across a biologics portfolio, supporting monoclonal antibodies, bispecifics, and targeted-delivery platforms.
Design and lead PK, bioanalysis, and immunogenicity studies to optimize candidate selection and progression.
Collaborate with cross-functional teams and external partners to ensure regulatory readiness and support IND filings.
Pioneering Medicines is the in-house drug development unit of Flagship Pioneering, focused on creating novel treatments from Flagship's scientific platforms. It is part of a larger organization known for innovation, with a collaborative and fast-paced culture.
Serve as the Clinical Scientist for one or more Phase 2/3 studies, contributing to study design, protocol development, and oversight.
Lead data review and medical monitoring activities, identifying trends, deviations, and safety signals in collaboration with Medical Monitors.
Support regulatory submissions, cross-functional partnerships, and scientific publications to advance clinical development.
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. It is a growing company with a collaborative, fast-paced environment where individual contributions have significant impact.
Own CMC oversight across every active asset, ensuring on-time and on-budget delivery of drug substance, drug product, analytics, stability, and regulatory filings.
Select, contract, and manage CDMOs and external partners, holding them to timelines, quality, and cost.
Scope and de-risk the CMC of inherited in-licensing candidates, flagging manufacturing complexity or cost that could affect asset viability.
Our mission is to fix the broken clinical-stage biopharma model by in-licensing therapeutic assets and developing them through integrated, technology-first clinical trial infrastructure. We are a new initiative built on a proven foundation, with a team that has delivered 40+ trials across the US and Europe, and we are a high-growth, mission-driven, VC-funded startup.