Development Translational Pharmacology Lead

Confo Therapeutics is the only GPCR company with a discovery engine that precisely targets desired GPCR conformations. This unique capability allows us to unlock a vast untapped potential for the discovery and development of breakthrough medicines. We are advancing a robust pipeline of small molecules and antibody-based therapeutics focused on validated targets in endocrine and metabolic diseases, as well as addressing a broader array of critical unmet medical needs in collaboration with our partners. Our team of around 60 people is dedicated to advancing our technology, expanding our capabilities, and building out our pipeline to achieve the best possible therapeutic outcomes for patients.

Confo Therapeutics is located on the Technology Park in Ghent. More information about Confo’s technology and strategy can be found on www.confotherapeutics.com.

For the expansion of our Development Team we are currently looking for a:
Development Translational Pharmacology Lead

Role overview:

We are seeking an experienced and motivated individual to join us in Ghent for a full-time, on-site role as a Pharmacology/Toxicology Lead. The Pharmacology/Toxicology Lead will oversee the relevant translational pharmacology and safety assessment studies to bring preclinical candidates into and through the IND/CTA application process, towards early clinical development. Responsibilities include designing and coordinating non-clinical studies in collaboration with Confo’s CRO network, analyzing data, and writing and reviewing reports, ensuring compliance with regulatory guidelines, and collaborating with cross-functional teams to advance drug development programs. Deliverables include scientific input and oversight, design, monitoring and reporting of studies, budget, and study timeline supervision and periodic reporting, as well as regulatory document review and vendor management. This position will frequently interact with Discovery, Bioanalysis, Regulatory, Clinical, CMC, Project Management, Quality, Legal and Finance, as well as external consultants and CROs.

Your Responsibilities:

• Support the Development organization in providing scientific leadership and oversight and coordination of non-clinical and clinical pharmacology and toxicology activities for both NCEs and NBEs. Manage relationships with CROs, including study proposals, protocol drafting, study monitoring and finalization and reporting of results, etc. in accordance with Confo’s internal procedures. Provide project leadership in pharmacology and toxicology, and design and coordinate additional non-clinical studies as appropriate and required, including both non-GLP and GLP studies.

• Collaborate with stakeholders in the Development and Discovery organizations in formulating the project strategy for translation of preclinical biomarkers and their incorporation in the development plan, the development of assays and the execution of studies, in alignment with the cross-functional project team. Conduct and update periodic literature reviews and target / pathway / modality initial safety assessment, also including biomarker strategies (in collaboration with Clinical) as applicable for each project. Liaise with Development Project Management and ensure the development plan is periodically informed and updated by emerging data, both internal and external.

• Participate in effective cross-functional communication between Discovery and Development, internal and external KOLs, be adaptable in executing on decision-making activities that meet realistic timelines. Support external collaborations and licensing efforts, including partnering and due diligence activities, by assembling and reviewing applicable data packages and other tasks as required.

• Create and maintain project documents, file and maintain project information on secure data sharing platforms, and assist with preparation of project presentation material (e.g., PowerPoint slides). Be able to present project results and strategy both internally and externally.

• Contribute to writing regulatory documents (including, but not limited to, briefing books for scientific advice meetings with health authorities), and participate and present non-clinical study data and plans to health authorities.

• Collaborate in the review of internal procedures, especially as it relates to GxP studies. 

• Some travel (domestic and international) may be required depending on business needs.

• PhD or equivalent experience is essential.

• 7 or equivalent years of experience in pharmacology, toxicology, veterinary sciences, or a related scientific discipline, with at least 5 years of relevant experience in the pharmaceutical industry, and specifically in drug development projects, is essential. Specific background in endocrine / metabolic diseases, and associated translational biomarkers in the non-clinical and clinical space, is a strong plus.

• Knowledge of and experience in small molecule and/or biologics drug development, specifically around the main pharmacology and toxicology activities leading to and including IND and/or CTA submission, is essential.

• Strong data analysis skills, including experience in DMPK, TK analysis and interpretation, FIH dose projection and safety margins calculation and review is a strong plus.

• Experience in preparation and/or review of regulatory documents such as GLP and non-GLP study reports and relevant sections of INDs, CTAs, is essential; general knowledge of applicable regulatory guidance documents (e.g., GLP, ICH) and compliance standards is a strong plus.

• You are a highly collaborative, self-motivated, team-oriented individual, able to work in a fast-paced, highly integrated team environment where accuracy, accountability and timelines are essential, you are fluent in English and with excellent communication skills.