Toxicology, Senior Manager to Associate Director

Company: Brii Biosciences Limited
Location: Durham
Posted on: April 8, 2021

Job Description:

Toxicology, Senior Manager to Associate Director Title: Toxicology, Senior Manager to Associate Director Department: Research and Developmen Reports to:Vice President of Preclinical Development Effective Date: 2021-3-1 Summary: As a subject matter expert, s/he will collaborate closely with multidisciplinary R&D functional areas to lead the development and execution of toxicology, safety pharmacology, and other critical safety studies in support of both clinical and preclinical pipelines, enabling decision making for advancement of both drug discovery and development projects. Primary responsibilities will include development and implementation of program-specific toxicology strategies in support of a rapidly growing portfolio. Prior experiences with preparation and review of regulatory filing documents to support IB, FIH and CTA filings is required. The ideal candidate will be familiar with the international regulatory requirements for toxicology and pharmacology and have broad experiences with the development strategies for small molecules, oligonucleotides, and protein therapeutics. DUTIES AND RESPONSIBILITIES:

• Serve as subject matter expert in supporting discovery and development projects across diverse therapeutic areas that containing small molecule and protein therapeutics, contribute to the project strategies and provide recommendations for key in vitro and in vivo toxicology studies.
• Characterize the toxicology profiles of candidate molecules and provide input into investigative studies and clinical starting dose strategies.
• Design, execute, analyze, and present Toxicology-related data to internal project teams and senior management.
• Support regulatory submissions and interactions with regulatory authorities with in-depth knowledge on subject matter area, regulatory requirements and guidelines related to toxicology and nonclinical drug development in general.
• Manage collaborations with CRO/CMO for outsourcing activities and ensure high quality study execution to meet program timelines. QUALIFICATIONS:
  • Ph.D. or equivalent in pharmacology, toxicology or a related discipline and a minimum of 0-2 or 3-5 years of relevant industry experience.
  • Hands on experience in designing and monitoring non-GLP and GLP toxicology studies, as well as data interpretation for small molecule and/or protein therapeutic programs.
  • Solid knowledge of preclinical drug development and regulatory filing documents, including authoring and review of relevant sections of regulatory submissions (e.g. INDs, NDAs, BLAs) is required.
  • Hands on experience interacting with global health authorities, and an in-depth understanding of the relevant pharm/tox regulatory guidance is preferred but not required.
  • Strong written, verbal, and interpersonal communications skills including ability to communicate scientific information clearly and effectively.
  • Demonstrated ability to work effectively with cross-functional groups and external partners/CROs in a matrix team environment. The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Keywords: Brii Biosciences Limited, Durham , Toxicology, Senior Manager to Associate Director, Executive , Durham, North Carolina