ppAlfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa. /p pOver three years ago, we embarked on a transformative journey to become ba truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health /b. We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities. /p pbBut our journey is far from complete! /b In fact, this is just the beginning of a bold new chapter in Alfasigma's history. We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets. /p h3Position Summary /h3 pThis role is responsible for supporting the characterization of the clinical pharmacology profile of compounds within the Alfasigma pipeline. The Sr. Manager, Global Clinical Pharmacology serves as a key representative in cross-functional program and study teams, contributing to the development of clinical pharmacology strategies and overseeing the execution of studies and analyses through external CROs. /p pThe role includes contribution to regulatory documentation, presentation of PK/PD data to internal stakeholders, and involvement in scientific publications. The individual also manages outsourced pharmacometric activities, including the development and implementation of PK/PD and disease models to support data‑driven decision‑making and evaluate agevolazioni‑risk profiles. /p h3Principal Accountabilities /h3 ul libLead /b the design and execution of Phase 1 clinical pharmacology studies (e.g., SAD, MAD, bioavailability, organ impairment, drug‑drug interaction), including collaboration with clinical teams in CRO selection. /li libProvide scientific input /b into study protocols,



statistical analysis plans, data interpretation, and clinical study reports, particularly for Phase 2 and 3 studies, while representing Clinical Pharmacology in cross‑functional teams. /li libDevelop and implement /b PK/PD strategies, including dose selection and justification, and exposure‑response analyses in collaboration with Translational Sciences. /li libCollaborate cross‑functionally /b with pharmacologists, toxicologists, medical directors, biostatisticians, and regulatory affairs to ensure timely delivery of analyses and regulatory documents. /li libDeliver high‑quality analyses /b and interpretation of clinical pharmacology data to support program decisions. /li libAuthor and contribute /b to clinical pharmacology sections of regulatory documents, including INDs, NDAs/BLAs, CTAs, Investigator Brochures, DSURs, and briefing packages. /li libSupport scientific communication /b, including publications and external data disclosures. /li libManage outsourcing /b of pharmacometric analyses (e.g., disease models, exposure‑response models, mechanistic PK/PD models) ensuring quality and alignment with development goals. /li libMaintain and enhance expertise /b in clinical pharmacology and drug development through continuous learning and external engagement. /li libEnsure compliance /b with applicable regulations, including GCP, GLP, and ICH guidelines, maintaining scientific integrity at all times. /li libPerform additional responsibilities /b as assigned, in alignment with company values and policies. /li /ul h3Qualifications /h3 h3Work Experience /h3 ul liMinimum b7 years /b of relevant industry experience with a Bachelor’s degree, or b4 years /b with an advanced degree, in Clinical Pharmacology and/or Clinical PK/PD. /li liProven experience in the design,



execution, and interpretation of clinical pharmacology studies, including PK and PD assessments. /li liDemonstrated ability to integrate biology, physiology, pharmacology, and biochemistry with PK/PD and drug development. /li liTrack record of contributing to clinical and preclinical pharmacology strategies and regulatory submissions. /li liStrong knowledge of current regulatory guidelines and expectations. /li /ul h3Education /h3 ul liBachelor’s, PharmD, or PhD in bPharmacology, Pharmaceutical Sciences, Biological Sciences /b, or a related field. /li liAbility to operate effectively in a bmatrix environment /b and collaborate across diverse teams and leadership styles. /li liProactive mindset with strong ownership and ability to seek support when needed. /li liExcellent bproblem‑solving skills /b, attention to detail, and ability to work under time and resource constraints. /li liHands‑on experience with bnon‑compartmental and compartmental PK/PD analysis /b (e.g., WinNonlin or similar tools). /li liAdvanced proficiency in bMicrosoft Office Suite /b (Word, Excel, PowerPoint) and tools such as Prism. /li liStrong bwritten and verbal communication skills /b. /li liHigh blearning agility /b and ability to scale responsibilities in a growing organization. /li liAbility to badapt and perform effectively in uncertain and evolving environments /b. /li /ul pbWhy Join Alfasigma: /b /p pbAt Alfasigma, we foster a culture where the courage to innovate is key to our success. /bbr/We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development. /p pOur commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open‑mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress. /p pbJoin Alfasigma and become part of a forward‑thinking team dedicated to shaping the future of the pharmaceutical industry. /b /p /p #J-18808-Ljbffr

📌 Sr. Manager, Global Clinical Pharmacology (Milano)
🏢 Alfasigma
📍 Milano