Early Clinical Scientist – Translational Medicine

This is a fully remote position, open to applicants in New York.

📋 Description

• Facilitate the design, planning, and implementation of early-phase clinical trials in collaboration with the Clinical Director and both internal and external team members.

• Supervise trials within and/or across various programs or therapeutic areas.

• Ensure high standards in execution and adherence to compliance to meet study objectives and maintain data integrity.

• Oversee the performance of internal and external teams to fulfill project goals.

• Address and resolve any project performance challenges.

• Ensure thorough clinical safety evaluations and effective risk management of compounds.

• Conduct real-time monitoring of ongoing trials to identify and address patient, study design, data, or conduct issues.

• Analyze and interpret clinical trial data.

• Potentially engage in on-site study monitoring, which includes training sites and supervising complex, innovative endpoint/biomarker collection processes.

• Utilize knowledge of GCP, ICH guidelines, and regulatory requirements related to clinical development.

• Co-author clinical sections of protocols, clinical investigator brochures, and clinical study reports.

• Create operational documents for studies, such as site monitoring plans, study operations manuals, and informed consents.

• Manage trial and program projects, team activities, risk assessments, and contingency plans under accelerated timelines.

• Enhance knowledge and skills to oversee additional early drug development processes and procedures.

⛳️ Requirements

• Proven experience in managing CROs from the sponsor's perspective for Phase 1 clinical trials.

• Proficient in Clinical Trial Management and Trial Master File systems.

• Skilled in authoring Protocol Concepts.

• Capable of facilitating a Trial Team that includes cross-functional partners such as regulatory experts, clinical supplies managers, data managers, statisticians, programmers, and procurement professionals.

• Ability to manage multiple projects simultaneously.

• Experienced in reviewing protocols, informed consent forms (ICFs), Investigator's Brochures (IBs), Clinical Study Reports (CSRs), biomarker processes, as well as site and medical monitoring plans, risk assessments, and protocol deviations.

• Proficient in using Microsoft Teams.

• Comprehensive understanding of the clinical research development process from program planning to regulatory submission.

• Ability to rapidly acquire scientific knowledge in various therapeutic areas.

• Capacity to manage complex operations and projects under tight timelines.

• Experience in scientific, medical, and/or safety writing and reporting; at least one of these is required.

• Proven ability to collaborate effectively with internal and external teams to achieve objectives.

• Strong skills in team collaboration, leadership, communication, issue identification, and resolution.

• Knowledgeable in GCP, ICH guidelines, and regulatory requirements.

• A degree in Life Sciences is required.

• A Bachelor’s degree with ≥7 years of related experience, a Master’s degree with ≥5 years of related experience, or a PhD/doctorate degree with ≥1 year of relevant experience is necessary.

🏝️ Benefits

• Competitive salary package.

• Comprehensive health benefits.

• Opportunities for professional development and growth.

• Collaborative and inclusive work environment.