Job Description

Company Overview

Anokion is a clinical-stage biotechnology company that aims to make a meaningful difference in the lives of patients suffering from autoimmune diseases by restoring normal immune tolerance. The company is focused on both prevalent and rare autoimmune diseases, including celiac disease, multiple sclerosis, and type 1 diabetes. Anokion\xe2\x80\x99s distinct approach leverages the company\xe2\x80\x99s immune-based platform, which targets natural pathways in the liver to restore immune tolerance and address the underlying cause of autoimmune disease.

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Job Summary

The Director, Clinical Scientist will report to the Chief Scientific Officer and support the company\xe2\x80\x99s early clinical drug development program(s).

Director, Clinical scientist will provide leadership for trial development strategy, clinical study design and implementation, and translational strategy. The successful candidate will have experience in design, execution, and interpretation of early and mid-stage clinical studies, including those with translational/biomarker assessments. Responsibilities will include, but are not limited to, design and interpretation of clinical studies, including protocol development and oversight, and developing translational biomarker plans.

Senior Director level can be considered based on experience.

Responsibilities and Duties

• Interface internally and externally as the clinical science lead in support of the clinical programs
• Review, analyze, and interpret emerging clinical trial data (including biomarkers, clinical pharmacology, and safety data) and lead preparation for key study meetings (e.g. investigator meetings, safety monitoring committees, advisory boards)
• Participate in project development team and liaise with broader team to ensure successful study execution (clinical operations, statistics, data management, and regulatory teams)
• Partners with medical safety on oversight of clinical trial activities, including safety reviews and site interactions
• Manages the preparation of clinical study documents including study protocols, amendments, specific sections of study manuals, and other documents as needed. Author, edit, and review study reports for regulatory submissions.
• Collaborate with clinical, regulatory and research teams to develop and implement the clinical biomarker strategy for mid-phase clinical studies, including development of novel endpoints
• Contribute to the development of presentations, abstracts, and publications emerging from clinical and translational studies
• Works closely with internal and external stakeholders to accumulate scientific, regulatory and clinical knowledge necessary to support clinical development
• Maintains quality control and high standards throughout the lifecycle of each project. Identify areas of best practice and process improvement.

• Advanced degree in life science field (PhD, PharmD, or DVM)
• Must have 10+ years overall and 5+ years clinical research experience in pharmaceutical and/or biotech companies; direct translational experience highly desired
• Experience with review and analysis of clinical data, including biomarker data
• Experience managing development and review of clinical study documents
• Experience working with and managing CRO(s); experience working in joint research collaborations desirable
• Demonstration of strong written and communication skills- the ability to clearly and persuasively articulate complex concepts and strategies to a diverse audience
• Expertise relating to all aspects of the drug development process and the ability to identify and resolve complex methodological issues relating to programs
• Knowledge of GCP and ICH guidelines and other regulatory requirements
• Ability to build strong relationships and work effectively with cross-functional teams
• Desire and ability to work in a fast-paced, cross-functional, flexible and team-oriented environment

Anokion