Apply on Employer Site

AstraZeneca · 6 days ago

Director, Project Toxicologist, BioPharma Safety in Clinical Pharmacology & Safety Sciences (CPSS)

Waltham, MA

Full-time

Hybrid

Director/Executive

$179K/yr - $268K/yr

10+ years exp

AstraZeneca is a global biopharmaceutical company focused on disease modification and improving patient outcomes. They are seeking a Director, Project Toxicologist in Clinical Pharmacology & Safety Sciences to provide non-clinical safety expertise for drug development, assess safety risks, and contribute to project strategies across clinical phases.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

H1B Sponsor Likely

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

PhD in toxicologyNon-clinical safety leadRegulatory toxicologyDrug developmentToxicology programsVitro experimentsVivo experimentsRegulatory guidelinesDABT certificationERT certificationCommunication skillsProblem-solving skillsCollaborative working style

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 handson 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 in accordance with the terms of the applicable plans

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees

https://www.astrazeneca.com

H1B Sponsorship

AstraZeneca 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

2021 (2)

2020 (11)