Clinical Scientist, Clinical Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Design, implement, and analyze clinical trials that support the development of innovative antibody-based therapies.

• Collaborate with teams across clinical operations, data management, CROs, regulatory affairs, translational science, and biomarker initiatives.

• Analyze clinical trial data to spot trends, resolve discrepancies, and ensure compliance with patient safety and study protocols.

• Evaluate adverse events, laboratory results, concomitant medications, medical histories, and clinical data queries.

• Assist with the responsibilities of the Medical Monitor.

• Contribute to the design of studies and amendments to protocols.

• Draft and support the submission of protocols, regulatory documents, and related materials.

• Aid in site selection, study initiation, trial metric monitoring, risk-based quality oversight, and study closure.

• Create and review abstracts, posters, scientific meeting content, presentations, and publicly available materials.

• Write clinical science sections for meeting packages and assist with clinical documentation for regulatory submissions.

• Work alongside Regulatory Affairs to ensure that study designs comply with FDA/ICH and GCP standards.

• Develop and maintain protocols, clinical study reports, investigator brochures, and informed consent documents.

• Monitor the competitive and scientific landscape of therapeutics and contribute to the strategic positioning of pipeline programs.

• Carry out additional duties as assigned.

⛳️ Requirements

• A minimum of 5 years of clinical development experience within the biotech or pharmaceutical industry.

• Ideally, at least 2 years of experience in immunology, gastroenterology/IBD, or immune-mediated disease areas.

• Bachelor's degree in life sciences, clinical pharmacology, immunology, or a related field.

• Proven experience in executing clinical trials in IBD or another inflammation and immunity therapeutic area.

• Knowledge of clinical biomarkers, PK/PD modeling, patient stratification, and immunological endpoints.

• Familiarity with FDA/ICH guidelines and Good Clinical Practice (GCP).

• Demonstrated ability to function effectively in a cross-functional matrix organization.

• Exceptional written and verbal communication, presentation, and interpersonal skills.

• Ability to influence a diverse group of stakeholders.

• Comfortable working in a fast-paced, dynamic environment with ambiguity and readiness to take on multiple roles.

🏝️ Benefits

• Competitive compensation and benefits package.

• Performance-related bonus.

• Opportunities for equity grants.

• Comprehensive health benefits.

• Welfare benefits.

• Retirement benefits.

• Unlimited paid time off (PTO).

• Two company-wide shutdowns of one week each.

• Opportunities for professional development.

• Flexible remote working environment with regular in-person meetings.

• Chance to thrive in a fast-paced, dynamic environment, contribute broadly to the advancement of meaningful medicines, and rapidly acquire new knowledge.