CAREERS
Key Responsibilities:
Provide strategic planning and oversight of toxicology assessment of Degron's novel molecule glue drugs, reporting to Chief Development Officer of the company.
Deliver nonclinical drug development support from target selection through clinical development.
Design and manage nonclinical toxicology programs for US and China filing
Preparation of tabular summary, written summary, nonclinical overview and Investigator's Brochure documents for IND submission.
Perform QC review on documents for submission to government agencies.
Resolution of toxicology and regulatory issues during nonclinical development of pharmaceutical candidates.
Conduct technical evaluation of CROs conducting toxicology studies.
Monitor studies at toxicology CRO sites.
Education & Experience Requirements:
PhD in toxicology or related biomedical field.
Board Certified toxicologist that works well in teams to deliver high quality science and drug development strategies.
At least 5 year of industry experience in biotech or pharmaceutical settings.
Small molecule oral drug development experience required.
Novel drug development or targeted protein degradation experience preferred.
Experienced in conducting studies in regulatory environment (chemical and pharmaceuticals).
Experience in preclinical toxicology program design and execution, data interpretation, and issue resolutions.
Prior experience in drafting regulatory documents such as pre-IND, IND, IB, and contributing to clinical protocols.
Extensive experience in GLP Toxicology study and US and China IND filing.
Leadership, project management skills, and experience with managing external vendors are essential.
Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem solving.
Strategic thinker with a professional demeanor, able to navigate an ambiguous environment.
Excellent organization skills with a drive for results.
Excellent written and verbal communication skills in English (required) and Chinese (preferred).
Compensation:
Market competitive plus all benefits. Commensurate with experience.
