Associate director, translational pharmacology

Our client is a biotechnology company that is developing very innovative treatments in the delivery of active ingredients by inhalation through non-viral nano-administration. The Company, indeed, is a start-up devoted to the clinical development of an innovative proprietary platform for the tissue-directed delivery of therapeutic peptides and RNAs. The start-up is part of the portfolio of an important multinational venture capital that is active across the entire value chain of life sciences investments, from seed to later-stage, with a focus on healthcare and sustainability. We invite you to take a look at this career opportunity and consider building your promising future by becoming a member of the team! Purpose of the position:

Strategic and operational responsibility of non-clinical pharmacology and toxicology activities, including PK/PD, safety pharmacology, and toxicology studies conducted in collaboration with external contract research organizations (CROs) for assigned projects ensuring strategic alignment with overall company goals. Contribution to the company's patent strategy and IP management.

Main Responsibilities:

Provide strategic oversight of toxicity, PK and PK/PD studies to support non-clinical and clinical PK prediction and quantify exposure-response relationships for target engagement, biomarkers, efficacy, and safety. Evaluating translational pharmacology data and advice cross functional groups on implications for clinical development and regulatory strategy. Lead the design and interpretation of non-GLP investigative and pharmacology studies for developmental compounds. Oversee the integration of in vivo, in vitro and ex vivo pharmacological models and their quantitative translation to evaluate safety and efficacy of candidate drugs. Integrates non-clinical data to inform translational strategies and predict dose/regimen for both non-clinical and clinical exposure-efficacy & toxicity assessments. Lead the preparation and communication of non-clinical pharmacokinetic and safety data. Act as primary contact for external partners conducting in vivo and in vitro studies. Define and implement toxicology strategies in conjunction with cross-functional groups, Plan, manage and oversee GLP-compliant toxicology studies and contribute to the auditing and assessment of GLP compliance at CRO responsible for GLP toxicology studies. Lead bioanalytical strategy for non-clinical and clinical studies, including method development, validation, and implementation support regulatory and internal decision. Ensure compliance with the Quality Management System and contribute to SOP development and review for Translational Pharmacology. Develop technical and scientific content for regulatory documents, ensuring scientific integrity and alignment with global requirements during submissions and interaction with regulatory agencies. Support the company's patent strategy and IP management, contributing to the resolution of IP-related challenges and opportunities.

Job Requirements:

University master's degree in biotechnology, Biological Sciences, Chemistry, Pharmacy or equivalent 6+ years' experience in R& D in pharma or biotech company Background and operational experience in Translational Pharmacology and GLP/GCP