Sr. Manager, Global Clinical Pharmacology

Alfasigma 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.

Over three years ago, we embarked on a transformative journey to become a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health. 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.

But our journey is far from complete! 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.

Position Summary

This 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.

The 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 benefit-risk profiles.

Principal Accountabilities

• Lead 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.
• Provide scientific input 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.
• Develop and implement PK/PD strategies, including dose selection and justification, and exposure-response analyses in collaboration with Translational Sciences.
• Collaborate cross-functionally with pharmacologists, toxicologists, medical directors, biostatisticians, and regulatory affairs to ensure timely delivery of analyses and regulatory documents.
• Deliver high-quality analyses and interpretation of clinical pharmacology data to support program decisions.
• Author and contribute to clinical pharmacology sections of regulatory documents, including INDs, NDAs/BLAs, CTAs, Investigator Brochures, DSURs, and briefing packages.
• Support scientific communication, including publications and external data disclosures.
• Manage outsourcing of pharmacometric analyses (e.g., disease models, exposure-response models, mechanistic PK/PD models) ensuring quality and alignment with development goals.
• Maintain and enhance expertise in clinical pharmacology and drug development through continuous learning and external engagement.
• Ensure compliance with applicable regulations, including GCP, GLP, and ICH guidelines, maintaining scientific integrity at all times.
• Perform additional responsibilities as assigned, in alignment with company values and policies.

Qualifications

Work Experience

• Minimum 7 years of relevant industry experience with a Bachelor’s degree, or 4 years with an advanced degree, in Clinical Pharmacology and/or Clinical PK/PD.
• Proven experience in the design, execution, and interpretation of clinical pharmacology studies, including PK and PD assessments.
• Demonstrated ability to integrate biology, physiology, pharmacology, and biochemistry with PK/PD and drug development.
• Track record of contributing to clinical and preclinical pharmacology strategies and regulatory submissions.
• Strong knowledge of current regulatory guidelines and expectations.

Education

• Bachelor’s, PharmD, or PhD in Pharmacology, Pharmaceutical Sciences, Biological Sciences, or a related field.

Competencies & Skills

• Ability to operate effectively in a matrix environment and collaborate across diverse teams and leadership styles.
• Proactive mindset with strong ownership and ability to seek support when needed.
• Excellent problem-solving skills, attention to detail, and ability to work under time and resource constraints.
• Hands-on experience with non-compartmental and compartmental PK/PD analysis (e.g., WinNonlin or similar tools).
• Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and tools such as Prism.
• Strong written and verbal communication skills.
• High learning agility and ability to scale responsibilities in a growing organization.
• Ability to adapt and perform effectively in uncertain and evolving environments.

Why Join Alfasigma:

At Alfasigma, we foster a culture where the courage to innovate is key to our success.
 We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development.

Our 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.

Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry.