Job Title: CLINICAL DEVELOPMENT MEDICAL SCIENCE DIRECTOR
Roma, IT
Angelini Pharma has been dedicated to improving the lives of patients with mental health disorders and, more recently, neurological conditions such as epilepsy. The company consistently invests in research to develop new products and ensure their effectiveness while advocating against the stigma surrounding these conditions.
Mental Health
In the field of mental health, Angelini Pharma provides treatments for depression, bipolar disorder, and schizophrenia, adopting a holistic approach that integrates innovative pharmaceutical solutions with support beyond the medicine, addressing biological, social, and environmental factors.
Epilepsy
For epilepsy, Angelini Pharma holds exclusive licensing rights to cenobamate in the EU and other EEA countries, an innovative treatment for focal-onset seizures in adults with drug-resistant epilepsy. The introduction of cenobamate in Italy in 2022 marked a significant step toward improving the quality of life for epilepsy patients.
R&D
In line with this commitment to Brain Health, the research and development pipeline includes three preclinical projects focused on Epilesies Syndromes and other rare neurological conditions. Additional research initiatives are currently under evaluation and are expected to expand the company portfolio in the next future.
The Global Clinical Development Medical Science Director (provides scientific and medical leadership across the global clinical development lifecycle. This role is responsible for designing, executing, and overseeing clinical development strategies and plans to ensure scientifically robust, ethical, and compliant clinical programs that support regulatory approval and commercialization worldwide.
The incumbent serves as the medical expert for assigned programs, working cross-functionally with Clinical Operations, Regulatory Affairs, Biostatistics, Safety, Commercial, and external stakeholders.
Key Responsibilities
1. Clinical Development Strategy
- Lead the medical strategy for global clinical development programs (Phase I–III).
- Design and contribute to clinical development plans (CDPs) aligned with global regulatory requirements.
- Define target product profiles and medical positioning strategies.
- Provide scientific leadership for indication expansion opportunities.
2. Protocol Development & Study Oversight
- Author and review clinical study protocols, amendments, investigator brochures, and related documents.
- Provide medical oversight during study conduct
- Ensure scientific integrity, patient safety, and compliance with ICH-GCP guidelines.
- Review eligibility criteria, endpoints, statistical assumptions, and safety monitoring plans.
3. Regulatory & Health Authority Interaction
Support regulatory submissions (IND/CTA, NDA/BLA/MAA).
Participate in interactions with global health authorities.
Contribute to briefing documents and responses to regulatory queries.
Ensure alignment with regional regulatory requirements.
4. Safety & Risk Management
Collaborate with Pharmacovigilance to monitor safety signals.
Participate in Data Monitoring Committees (DMC) and safety review meetings.
Evaluate benefit-risk profiles throughout development.
5. Scientific Communication
Present clinical data internally and externally.
Support publication strategy and review manuscripts and abstracts.
Represent the company at scientific congresses and advisory boards.
Provide medical input to commercial and medical affairs teams.
6. Cross-Functional Collaboration
Partner with Clinical Operations to ensure timely study execution.
Work with Biostatistics on statistical analysis plans and data interpretation.
Align with Market Access and Commercial teams on medical strategy.
Contribute to lifecycle management planning.
7. External Stakeholder Engagement
Build and maintain relationships with Key Opinion Leaders (KOLs).
Support advisory boards and expert panels.
Contribute to investigator selection and engagement.
EDUCATION:
MD preferred experience in Neuroscience
OTHER REQUIREMENTS:
- Minimum 10 - 15 years of experience in clinical development within the pharmaceutical/biotech industry.
- Experience leading global clinical programs
- Proven experience interacting with regulatory agencies ( FDA – EMA – PMDA)
Strong background in clinical trial design and data interpretation. - Deep understanding of ICH-GCP, FDA, EMA, and global regulatory frameworks.
- Experience with safety data evaluation and risk management.
- Strong knowledge of biostatistics and clinical trial methodology.
- Strategic thinking and scientific rigor.
- Strong leadership and influencing skills to manage a team
- Ability to work in a global, matrixed organization.
- High ethical standards and patient-centric mindset.
Travel Requirements
Up to 20–30% international travel (as required).
LINGUISTIC SKILLS:
Excellent written and verbal communication in English
