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.

As we continue to grow, we are seeking a remoted based Senior Medical Director, Clinical Development Leader- GI. This is a remote based position to be located in the US or EU.

Scope of the role:

The role provides strategic clinical leadership and medical oversight for assigned therapeutic area programs, ensuring the design, execution, and analysis of clinical trials meet the highest scientific and regulatory standards. This role serves as the primary Medical Expert, driving the medical strategy from protocol development through regulatory submission and post-approval activities, while safeguarding patient safety and facilitating external medical communication.

Your key responsibilities

:Clinical Leadership & Strategy

- :Provide high-level clinical leadership and medical strategy input for relevant programs
- .Offer guidance and oversight throughout the entire clinical trial process, from concept to completion




- .Act as the designated Medical Expert for the assigned program, therapeutic area (TA), and indication, ensuring medical rigor in all decision-making

.Protocol Development & Safety
- :Lead the development of clinical trial protocols with a specific focus on medical aspects, including patient eligibility criteria, treatment plans, and dosing strategie
- sCollaborate closely with Pharmacovigilance (PV) to monitor patient safety throughout the trials and manage risk mitigation strategie
- sReview, interpret, and report clinical trial data from a medical perspective to accurately assess the drug’s efficacy and safety profil

eRegulatory & External Engagement
- :Interact with regulatory authorities and ethics committees, providing essential medical insights during submissions and addressing any scientific or medical concern
- sSupport Therapeutic Area (TA) Heads in external medical communications directed at healthcare professionals, clinical investigators, and regulatory bodie

sBusiness Development
- :Collaborate with Product Management (PM) and Business Development (BD) teams to assess new opportunities and support BD activities, providing medical validation for potential assets or partnershi

pWho are you

- :MD required, PhD or comparable education a plu
- sExperience with IND, NDA, BLA, or MAA submissions and approval
- sBackground in biotech or pharmaceutical industr
- yPrior industry experience in contributing to the preparation of clinical protocols, study reports, IND, IB, NDA/CTD document
- sPrior industry experience in interactions and support of Medical Affairs and Commercial groups and activitie




- sAt least 10–15 years of experience in clinical development within the pharmaceutical or biotechnology industry, with a proven track record of successfully leading Phase I–III clinical trials. At least 5 years in a leadership rol
- eExperience in GI preferre
- dSolid understanding of Phase I – III drug developmen

tCore Competencies

- :Strong project management and excellent communication and negotiation skills
- .Ability to lead cross-functional teams in a matrix organization
- .Strong collaborative skills and a strategic thinke
- rStrong scientific and analytical skill
- sEntrepreneurial, hands-on, with perseverance and problem-solving skills
- .Able to work independently and effectively in complex, rapidly changing environments
- .Flexibility, diplomacy, and the ability to manage expectations
- .Strong presentation/interaction and time management skills
- .Proven ability to establish strong partnerships with key internal and external stakeholders
- .Thorough understanding of local compliance, as well as a sound ethical approach to business
- .A genuine passion for science and in making a difference in patient's live
- sExperience with emerging technologies (e.g., AI in trial design, real-world evidence

)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

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📌 Senior Medical Director- Clinical Development Leader- GI (Italia)
🏢 ALFASIGMA
📍 Italia