Associate Principal Scientist supporting regulatory strategies for Vaccine & Infectious Disease products. Collaborating globally and assisting submissions for regulatory compliance in the pharmaceutical industry.
About the role
- Senior Principal Scientist supporting nonclinical safety strategies for Degrader-Antibody Conjugate (DAC) programs. Overseeing toxicology studies, regulatory submissions, and cross-functional collaborations.
Responsibilities
- Design, oversee, and interpret IND-enabling nonclinical toxicology studies for DAC programs, including GLP toxicology, safety pharmacology, and toxicokinetic assessments.
- Serve as the nonclinical toxicology lead on assigned DAC programs, providing scientific input on nonclinical safety assessment, risk identification, and mitigation strategies.
- Support clinical starting dose selection and risk assessment in collaboration with DMPK and clinical development teams.
- Author and contribute to nonclinical sections of INDs and related regulatory documents.
- Collaborate closely with pharmacology, DMPK, pathology, bioanalytical, CMC, regulatory affairs, and clinical development teams.
- Manage external CROs and consultants, ensuring scientific quality, timelines, and budget adherence.
Requirements
- PhD in Toxicology, Pharmacology, Biology, or a related discipline.
- Minimum of 5 years of relevant industry experience in nonclinical drug development.
- Demonstrated experience leading IND-enabling toxicology programs and supporting successful IND submissions.
- Strong hands-on and/or strategic experience with ADC-based molecules (ADC or DAC) is required.
- Experience managing CROs and working effectively in cross-functional teams.
- Prefer DABT certified but not required.
- Prior experience with targeted protein degradation or other emerging modalities.
- Experience participating in regulatory agency interactions.
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Senior Research & Innovation Assistant focused on sustainable solutions for polymers and textiles at Solvay. Collaborating with a diverse scientific community to enhance innovative practices.
Senior Research Scientist for circuit technology development at NVIDIA. Collaborating with elite researchers to advance high - performance, low - power circuit technologies.
Research Assistant supporting negotiation of physician managed care contracts and ensuring compliance standards. Managing processes for tracking insurance payor issues and coordination of meetings.
Senior Scientist, Statistical Genetics at Novo Nordisk Research Center China. Leveraging human genetic evidence to inform drug discovery and portfolio decisions in a collaborative research environment.
Research Assistant supporting sustainable agriculture research and outreach programs at University of Maine. Involves field, greenhouse, and laboratory management along with educational outreach efforts.
SI
Associate Principal Scientist responsible for developing and implementing regulatory CMC strategies at Organon. Leading the preparation and submission of CMC dossiers for product lifecycle milestones.
Research Assistant contributing to the Discovering Liveability project for suicide prevention. Focused on innovative research centering lived experiences of suicide over a fixed - term of 5 years.
Applied Scientist leading the development of generative AI for Adobe Creative Cloud. Focusing on graphics and vector - based design workflows with advanced machine learning techniques.
Senior Applied Scientist developing production - grade language generation systems with a focus on neurosymbolic AI at UnlikelyAI. Collaborating with a world - class team on innovative AI technologies.