Senior Toxicologist, Non-Clinical Pharmacology Scientist

Sobi

About The Position

Sobi is seeking an experienced Senior Toxicologist, Non-Clinical Pharmacology Scientist to join its Preclinical Development and Translational Medicine (PDTM) Department. The role is responsible for Toxicology and Non-Clinical Pharmacology activities within assigned projects, supporting Clinical and Core Asset Teams for products in development and geographic expansions of established products. The position is open to be located in Europe. The role provides overall accountability for Toxicology and Non-Clinical Pharmacology strategies and activities in appointed projects, contributes expert knowledge to cross-functional teams, manages preclinical safety studies at Contract Research Organizations, and supports regulatory documentation and interactions. It also involves integrating translational considerations and safety findings into benefit-risk discussions, assessing impurities, and contributing to scientific communications.

Requirements

PhD, DVM, or equivalent in a relevant discipline.
At least five years of experience as a project toxicologist.
Demonstrated ability to manage multiple projects across various development stages.
Experience with biologics and small molecules.
Extensive regulatory toxicology experience and a solid understanding of the drug-development process, including late-stage development and life-cycle management for established compounds.
Fluency in written and spoken English.
Excellent communication and presentation skills.
Energetic, driven, and able to take initiative with a can-do attitude.
Results- and delivery-focused, with a structured approach to work.
Good problem-solving ability and an analytical mindset.
Strong personal accountability and ability to work independently, as well as strong teamwork skills.

Nice To Haves

Experience with oligonucleotides, gene therapy, or combination drugs.
Board certification such as DABT or ERT.
Experience in immunotoxicology.

Responsibilities

Define appropriate Toxicology and Non-Clinical Pharmacology strategies for assigned projects.
Hold overall accountability for Toxicology and Non-Clinical Pharmacology strategies and activities in appointed projects.
Provide expert Toxicology and Non-Clinical Pharmacology knowledge to cross-functional teams.
Prepare and own Toxicology and Non-Clinical Pharmacology modules and sections in regulatory documents, including IB, IND and IMPD summaries, RMP, and briefing documentation.
Manage interactions with regulatory authorities regarding non-clinical pharmacology and Toxicology questions for assigned projects.
Manage preclinical safety studies at Contract Research Organizations, including study design, monitoring, discussion, and reporting of safety findings.
Ensure translational aspects are considered, optimally used, and integrated; communicate and discuss safety alerts from literature or Toxicology studies within the Benefit/risk team.
Perform Toxicology assessments for drug-product impurities and support questions from manufacturing sites.
Participate in internal and external scientific communications, including oral presentations, posters, and publications.