Site Head / Director Bioanalytical And Biomarker Services Bardi

Site Head / Director Bioanalytical And Biomarker Services
Bardi
Emilia Romagna, Bardi

Site Head / Director Bioanalytical and Biomarker Services Frontage Laboratories, Inc appcast. io Location: Nerviano, Lombardy area, Italy Type: Full-time, On-site Compensation: Competitive salary, performance linked bonus and equity Frontage Laboratories Inc. Frontage Laboratories is an award-winning global contract research organization, Head Quartered in Pennsylvania, USA with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates over 25 sites across the USA, Canada, China and Italy. Frontage's core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, clinical research, and core laboratory services for clinical trials. Position Summary This leader will lead a team of scientists and other support functions, playing a critical role in advancing biomarker, bioanalytical, central lab, radiosynthesis and other services. The role will be responsible for all areas of the site including client engagement, method development and quality, compliance while supporting business development and leading the overall growth. Key Responsibilities Provide expertise and strategic direction to enhance biomarker, bioanalytical, laboratory services, radiosynthesis and other services offered by the company. Develop long and short-term goals and metrics, enhance capabilities and support the growth of the business. Serve as the Subject Matter Expert (SME) and problem solver to internal teams and clients on SOPs, best practices, project timelines and study protocols. Be a champion of continuous improvement of processes. Present Frontage's service capabilities to prospective clients, support business development team, guide in writing and reviewing proposals, RFPs, SOWs, and client contracts. Ensure studies are conducted following SOPs, best practices and in strict GLP regulatory compliance. Host and lead regulatory audits and guide responses for technical and QA audits. Education and Experience MSc/PhD or equivalent focused on biological sciences, analytical chemistry, biochemistry, or a related field. 15 years of experience in biotech or pharmaceutical industry. CRO experience would be ideal. Strong exposure to various stages of drug development with significant experience in biopharmaceutical testing involving biomarkers and large molecules using LC-MS/MS, will be ideal. Experience in a GLP environment and familiarity with FDA, EMA, CLIA and other regulatory guidelines. Preferred Skills Excellent leadership, collaboration and communication skills with the ability to coach, mentor, train, inspire and lead a cross functional team to high-performance. Ability to excel in a fast-paced and multi-cultural business environment while simultaneously managing multiple time sensitive projects. Strong analytical and business skills with a growth mindset. Ability to participate and present in industry technical and trade groups, scientific forums and enhance Frontage's brand in the region that would generate new business leads. Maintain current knowledge of scientific advances and regulatory changes. Please apply with your resume indicating compensation requirements J-18808-Ljbffr