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 t ranslational 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