About this role
Alfasigma is a privately held global healthcare company founded over 75 years ago in Italy, headquartered in Bologna and Milan. It operates in over 100 markets and focuses on Gastrointestinal health innovation. The Sr. Manager, Global Clinical Pharmacology supports characterization of pipeline compounds' profiles.
This role serves as a key representative in cross-functional teams, developing clinical pharmacology strategies. It oversees execution of studies and analyses through external CROs. Responsibilities include PK/PD data presentation and regulatory documentation contributions.
Daily work involves leading Phase 1 studies like SAD, MAD, and drug-drug interactions. Collaborate with clinical teams on CRO selection and protocol development. Manage outsourced pharmacometric activities including disease and exposure-response models.
Work cross-functionally with pharmacologists, toxicologists, medical directors, and regulatory affairs. Ensure timely delivery of analyses for program decisions. Author sections for INDs, NDAs, CTAs, and support scientific publications.
Join Alfasigma's bold new chapter of growth and innovation. Expand expertise in clinical pharmacology through continuous learning. Advance patient health worldwide in a transformative global environment.
Requirements
- Advanced degree in pharmacology, pharmaceutical sciences, or related field
- Experience in designing and executing Phase 1 clinical pharmacology studies
- Proficiency in PK/PD modeling and pharmacometric analyses
- Knowledge of exposure-response and disease progression modeling
- Familiarity with regulatory documentation for INDs, NDAs, CTAs, and briefing packages
- Experience managing CROs for clinical studies and pharmacometric activities
- Understanding of GCP, GLP, and ICH guidelines
- Ability to interpret PK/PD data for benefit-risk evaluations
Responsibilities
- Lead the design and execution of Phase 1 clinical pharmacology studies (e.g., SAD, MAD, bioavailability, organ impairment, drug-drug interaction)
- Provide scientific input into study protocols, statistical analysis plans, data interpretation, and clinical study reports
- Develop and implement PK/PD strategies, including dose selection, justification, and exposure-response analyses
- Collaborate cross-functionally with pharmacologists, toxicologists, medical directors, biostatisticians, and regulatory affairs
- 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
- Support scientific communication, including publications and external data disclosures
- Manage outsourcing of pharmacometric analyses (e.g., disease models, exposure-response models)
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