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 studie s 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