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

About the position At AstraZeneca, it is our bold ambition to achieve disease modification, clinical remission, and cure, to impact the lives of millions of people worldwide suffering from cardiovascular, renal, metabolic and respiratory diseases. We are now expanding our diverse pipeline to secure leadership in numerous BioPharma indications. We are looking for a motivated and passionate individual to join us as a Director, Project Toxicologist, BioPharma Safety in Clinical Pharmacology & Safety Sciences (CPSS) with a focus on enabling the delivery of transformative and safe drugs to patients. This is a Senior Project Toxicology position. As an individual contributor you will provide non-clinical safety expertise for our diverse portfolio containing a broad range of drug modalities. This high-impact development role supports the advancement of the BioPharma pipeline by designing, planning and interpreting toxicology studies, assessing safety risks, and contributing to project strategy supporting all phases of clinical development. The position is based in a collaborative, multidisciplinary environment within the Clinical Pharmacology and Safety Sciences function. The position will be based at one of our vibrant strategic R&D sites in Boston (MA) (3 days onsite per week)

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.

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 preferred, additional work experience in pharma industry in lieu of degree can be considered (ie. BSc with 18 yrs of experience). Minimum BSc degree with additional work experience in pharma industry required.
• 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.

Nice-to-haves

• Certifications such as Diplomate of the American Board of Toxicology (DABT) and/or European Registered Toxicologist (ERT) is preferred.

Benefits

• Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
• Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

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