Pre-clinical Scientist

Summary

This position reports to the department head of non-clinical sciences. The Non-Clinical Scientist provides the overall leadership regarding the non-clinical scientific and strategy for an asset and is accountable for meeting all non-clinical objectives for the program. Most of the non-clinical work will be done in collaboration with internal and external consultants and executed at external contract research organizations.

Education and Credentials

• Ph.D. in a relevant field.

Experience

• At least 3 years of experience in all types of non-clinical studies (pharmacology, pharmacokinetics, toxicology, etc.) working for pharmaceutical, biotechnology, or CRO company.

• The candidate should be broadly skilled and contribute to the successful execution of both discovery and development programs.

Skills

• Demonstrated ability to manage multiple and diverse projects concurrently.

• Demonstrated ability to develop positive relationships and collaborations.

• Strong analytical skills; a strategic thinker, planner, and implementer.

• Solid scientific skills with relevant non-clinical study design and methodology understanding.

• Working knowledge of statistics, data analysis, and data interpretation.

• Ability to operate independently with minimal supervision.

• Experience with literature analysis, designing and writing protocols, study reports, reviewing and evaluating data, preparing INDs, NDAs, BLAs.

• Understanding the operational aspects of all types of non-clinical trials and related activities.

• Excellent written and oral communication skills and a command of the English language.

• Strong proficiency in major Microsoft Office products (i.e., Word, Excel, PowerPoint, Project).

• Enthusiastic, genuine, ethical, fair, and loyal to the organization and its vision and goals.

Responsibilities

• Provides scientific oversight for responsible non-clinical research aspects of the project.

• Provides scientific input to the core documents for the project (e.g., product strategy documents, protocols, submissions, etc.).

• Consults with internal/external stakeholders and internal/external key opinion leaders.

• Provides scientific interpretation of all types of non-clinical data.

• Plays a key role in the interactions with regulatory authorities (e.g., FDA, EMEA meetings). This includes developing key documents, participating in preparation for meetings with the health authorities, and participating in the meetings and interactions with the health authorities. Serves as the leading non-clinical representative during these interactions.

• Creates and reviews abstracts and manuscripts created by internal or external sources.

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