As a Scientist in Pharmacology (Preclinical Operations) you will work closely with the internal Medicinal Chemistry, Biology, and Pharmacology teams as a subject matter expert in pharmacology. You will also work with external CROs or collaborators to provide oversight in the design, execution, and review of pharmacology studies in support of Athenex development programs. You will participate in project team meetings and help manage pharmacology content for regulatory submissions and reporting (e.g. INDs, NDAs, Annual Reports, and Investigator’s Brochures.). You will serve a technical writing role, composing written and tabulated nonclinical summaries based on pharmacology studies conducted by or on behalf of Athenex, and be an expert user of the nonclinical document templates that are consistent with FDA and ICH guidelines and with electronic submissions guidelines.
Key responsibilities include the following:
· Develop and implement pharmacology translational strategy for Athenex product development.
· Be a subject matter expert regarding the regulatory requirements for pharmacology studies (primary, secondary, and safety pharmacology).
· Work with the Medicinal Chemistry team in the screening and evaluation of drug candidates.
· Work with the Biology team and external CROs to design, execute, and report on pharmacology studies.
· Serve as a liaison to external CROs, which includes communicating with study directors, reviewing study proposals, reviewing protocols/reports, and meeting study timelines.
· Participate in project team meetings as a pharmacology expert to lead discussions regarding study requirements, documents, and timelines in context with the overall program development of a drug.
· Performs other duties as assigned (e.g. manage pharmacokinetic or toxicology studies).
Required Education and Qualifications
· Ph.D. with 0-3 years relevant work experience or M.S. and 3+ years relevant work experience or B.S. and 6+ years of relevant work experience in Pharmacology or Biology.
· Excellent written and oral communication, interpersonal and problem-solving skills
· Strong understanding of how to manage nonclinical studies, organize nonclinical data, and write research reports.
· Understanding of the drug development process and global regulatory guidance.
· Proficient in Microsoft® Suite (Word, Excel, PowerPoint, Project).
· Experience with electronic document management and tracking systems is a plus.
o Experience in oncology
o Experience in scientific writing
o Resourcefulness, pragmatism, and independent work ethic
o Can manage multiple projects under tight timelines, working independently and collaboratively
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.