Director, Project Toxicologist – Biopharma Safety
AstraZeneca
full-time
Posted on:
Location Type: Office
Location: Waltham • Maryland, Massachusetts • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- Provide non-clinical safety expertise for a diverse discovery portfolio containing a broad range of drug modalities.
- Design, plan and interpret toxicology studies, assessing safety risks for BioPharma projects.
- Design, deliver, and interpret innovative toxicology strategies to predict, assess and mitigate target- and modality related safety risks.
- Develop and implement innovative solutions combining regulatory toxicology with new science and technologies to progress drug candidates to clinic and market.
- Influence project strategy and decision making by communicating integrated risk assessments to internal governance bodies and external health authorities.
- Deliver quality nonclinical summaries and contribute to regulatory submissions.
- Maintain expertise in regulatory requirements and preclinical safety approaches and awareness of industry trends.
- Provide experienced nonclinical evaluation of in-licensing and out-licensing opportunities.
- Provide mentorship and guidance to emerging toxicologists and support their career growth and development.
Requirements
- A PhD in toxicology, cell biology, pharmacology, systems biology, or a related scientific discipline, or an advanced university degree accompanied by at least 10 years of relevant professional experience.
- Extensive experience in the pharmaceutical or biotechnology industry working as a non-clinical safety lead supporting cardiovascular, renal, metabolic or respiratory programs.
- Experience with planning, execution, interpretation and communication of regulatory toxicology data.
- Experience with design of strategies and execution of in vitro and in vivo experiments to determine the safety and efficacy of cardiovascular, renal, and metabolism therapeutics.
- Proven understanding of drug development and track record of delivering multiple toxicology programs from IND through late-stage clinical development.
- New Drug Applications (NDA) or Biologics License Applications (BLA) submissions experience is preferred.
- Strong understanding of regulatory guidelines and experience with compilation of toxicology information into regulatory submission documents.
- Ability to solve problems in a goal-focused fashion and coordinate tasks across multiple projects.
- Excellent verbal and written communication, interpersonal and influencing skills.
- Adopting an inclusive and collegiate working style, and a desire to drive own- and support others development.
- Established record of scientific contribution in peer-reviewed journals and scientific symposiums.
- Desirable: experience with small molecules, siRNAs, ASOs, peptides, and biologics.
- Certifications such as Diplomate of the American Board of Toxicology (DABT) and/or European Registered Toxicologist (ERT) is preferred.
- Applications must include CV and a cover letter combined into a single document.
Benefits
- An inclusive environment where equal employment opportunities are available to all applicants and employees.
- If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
- Commitment to lifelong learning, growth and development for all.
- A Great Place to Work culture empowering employees to push the boundaries of science and challenge convention.
- Collaborative, multidisciplinary environment and opportunities to connect different thinking and generate new opportunities.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
toxicologydrug developmentregulatory toxicologyin vitro experimentsin vivo experimentssafety assessmentrisk assessmentNDA submissionsBLA submissionstoxicology data interpretation
Soft skills
problem-solvingcommunicationinterpersonal skillsinfluencing skillsmentorshipcollaborationgoal-focusedorganizational skillsleadershipcareer development support
Certifications
Diplomate of the American Board of Toxicology (DABT)European Registered Toxicologist (ERT)