Alexion Pharmaceuticals, Inc. · 1 month ago
Director, Project Toxicologist, BioPharma Safety in Clinical Pharmacology & Safety Sciences (CPSS)
Waltham, Massachusetts, United States of America
Full-time
Hybrid
Director/Executive
$179K/yr - $268K/yr
10+ years expAstraZeneca is a leading company focused on achieving disease modification, clinical remission, and cure for patients worldwide. They are seeking a Director, Project Toxicologist to provide non-clinical safety expertise for their BioPharma pipeline, designing and interpreting toxicology studies to support clinical development.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
As a core member of multi-disciplinary BioPharma drug development teams, you will design, deliver, and interpret innovative toxicology strategies to predict, assess and mitigate target- and modality related safety risks
Develop and implement innovative solutions to combine regulatory toxicology with ground breaking science and technologies to progress novel drug candidates to the clinic and through development to the market, in line with business needs
To influence project strategy and decision making, you will communicate clear positions on integrated risk assessments in various formats including informing internal decision-making governance bodies and interacting with external health authorities
Delivering quality nonclinical summaries and contribute to regulatory submissions
Maintain expertise in regulatory requirements and preclinical safety approaches applied to Drug Candidates and awareness of industry trends
Additional responsibilities include to provide experienced nonclinical evaluation of in-licensing and out-licensing opportunities and to provide mentorship and guidance to emerging toxicologists with respect to the regulatory environment and support their career growth and development in this field
Qualification
Required
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 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
Demonstrates a proven understanding of end-to-end drug development with a track record delivering toxicology programs from IND through late stage clinical development. Late-stage experience leading or contributing to New Drug Application (NDA) and/or Biologics License Application (BLA) submissions is essential for the role
Strong understanding of regulatory guidelines and experience with compilation of toxicology information into regulatory submission documents
Exhibits excellent verbal and written communication, strong interpersonal effectiveness, and the ability to influence stakeholders at all levels; this capability is essential for the role
Demonstrates an inclusive, collaborative working style that builds trust and shared ownership; combines a hands-on drive to dive into details when needed with a strong commitment to enabling others' success, consistently acting with an enterprise mindset across teams and functions
Ability to solve problems in a goal-focused fashion with willingness to challenge conventional thinking and capacity to coordinate tasks across multiple projects
Represent AstraZeneca interests, maintaining high ethical and scientific standards
Established record of scientific contribution in peer-reviewed journals and scientific symposiums
Experience with various modalities, such as small molecules, siRNAs, ASOs, peptides, and biologics for example
Preferred
Certifications such as Diplomate of the American Board of Toxicology (DABT) and/or European Registered Toxicologist (ERT) is preferred
Benefits
Short-term incentive bonuses
Equity-based awards for salaried roles
Commissions for sales roles
Qualified retirement programs
Paid time off (i.e., vacation, holiday, and leaves)
Health, dental, and vision coverage
Company
Alexion Pharmaceuticals, Inc.
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community.
1001-5000 employees
H1B Sponsorship
Alexion Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (49)
2024 (57)
2023 (51)
2022 (29)
2021 (27)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$5.8M2020-12-12Acquired
1999-02-12Post Ipo Equity· $5.8M
1996-02-29IPO
Leadership Team
Frederic Chereau
SVP, Strategy and Business Development
Imran Shakur
Director, IRT and Technology Lead
Recent News
bloomberglaw.com
2025-12-20
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