Director – Project Toxicologist – Immune Oncology safety

Director – Project Toxicologist – Immune Oncology safety

Requirements

• DABT or PhD in toxicology, immunology, or immunopharmacology with several years of experience in the pharmaceutical or biotechnology industry working as a non-clinical safety lead, supporting immune-Oncology programs with planning, execution, interpretation and communication of regulatory toxicology data.
• A proven understanding of drug development and a track record of delivering multiple toxicology programs to IND and through clinical development.
• High level of knowledge and expertise in designing toxicology strategies and delivering in vitro/in vivo and risk assessment of immune related risks / adverse events, driven by mechanism and/or TCE.
• Expertise in immunology or oncology, including T-cell biology.
• Ability to solve problems in a goal-focused fashion with willingness to challenge conventional thinking and capacity to 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.

Responsibilities

• As a core member of multi-disciplinary oncology 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 other high-level regulatory documents for internal decision bodies and external health authorities.
• Maintain expertise in regulatory requirements and preclinical safety approaches applied to Drug Candidates and awareness of industry trends.
• Additional responsibilities include providing 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 Immune oncology department.

Preferred Qualifications

• Experience with TCE and other large molecules will be desirable.
• In addition to possessing scientific competence, we value individuals who can contribute to our inclusive, positive, and collaborative working environment.
• DABT is considered an advantage.