Provide strategic pharmaceutical development guidance as CMC lead to cross-functional project teams.
Develop robust formulations and manufacturing processes to support rapid registration of QED products.
Manage CRO relationships, drug forecasts, and regulatory submissions for clinical supply.
BridgeBio is a biotech company pioneering a 'moneyball for biotech' approach to reduce risk and accelerate development of life-changing medicines for rare diseases. They foster a culture of curiosity and experimentation, working alongside respected industry minds to reengineer the future of biopharma.
Provide domain expertise to design and build AI tasks that amplify productivity.
Share knowledge about day-in-the-life workflows for regulatory submissions.
Generate or review reference ground-truth artifacts for evaluation.
Edison Scientific builds and deploys AI scientist agents to accelerate science and the development of new medicines. The team is ambitious and run by scientists and engineers from leading institutions across biology, physics, chemistry, and AI.
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.
Provide physician-level medical oversight for early-phase clinical trials, ensuring participant safety through screening, eligibility review, and real-time clinical decision-making.
Participate in Safety Review Committee meetings and dose-escalation decisions for first-in-human and ascending dose studies.
Review study protocols, informed consent forms, and safety monitoring plans, and serve as medical liaison during audits and inspections.
Celerion is a Contract Research Organization (CRO) specializing in Phase I and early-phase clinical trials, including first-in-human studies. They partner with pharmaceutical and biotechnology sponsors to advance new therapies, and emphasize integrity, trust, teamwork, and respect as core values.
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.
Create and execute clinical operational strategic plans aligned with product strategy and resource allocation.
Build, develop, and train internal staff and external vendors to enhance efficiency and engagement.
Oversee relationships with Contract Research Organizations, vendors, and investigative sites to ensure compliance with FDA and ICH GCP guidelines.
Lycia Therapeutics is a biotechnology company using its proprietary LYTAC platform to develop therapeutics that degrade extracellular and membrane-bound proteins. Founded in 2019, the company has raised $75 million in Series D financing and is headquartered in South San Francisco.
Leads the planning, conduct, and oversight of clinical studies per scope of work, ensuring compliance with protocols, SOPs, and regulatory requirements.
Acts as primary clinical point of contact for clients, develops study documents, and drives site feasibility and recruitment strategies.
Manages clinical teams, training, vendor oversight, and ensures data quality and timely deliverables across study phases.
Precision Medicine Group is a clinical research organization that provides outsourced clinical trial management services to pharmaceutical and biotechnology companies. The company fosters a collaborative culture focused on quality and compliance, and employs a team of experienced clinical professionals.
Independently manage all operational aspects of Phase I clinical trials from startup through closeout, ensuring adherence to protocols and regulations.
Oversee CROs and vendors to ensure alignment with study goals, budget, and timelines.
Lead the company-wide rollout of Veeva Vault, serving as a primary operational user and subject matter resource.
Absci is a clinical-stage biotechnology company leveraging generative AI for drug discovery through its Integrated Drug Creation platform. The company has a global presence with offices in the US, Switzerland, and Serbia, and fosters a collaborative, innovative culture.
Serve as subject matter expert defining gold standard for AI-generated clinical content.
Share knowledge about day-in-the-life working with data for regulatory submissions.
Identify realistic sources of variance or data corruption in study data.
Edison Scientific builds and commercializes AI agents for science to accelerate scientific discovery. They are assembling a small team of top researchers and engineers across AI and biology to build an AI scientist.