Senior Medical Director- Clinical Development Leader- GI

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. We are on a transformative journey to become a leading global innovative healthcare company with a focus on Gastrointestinal (GI) health, experiencing remarkable growth, portfolio evolution, and expansion into rare and specialty segments.

About the role

This remote-based position (US EST required) 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. The role serves as the primary Medical Expert, driving medical strategy from protocol development through regulatory submission and post-approval activities, while safeguarding patient safety and facilitating external medical communication.

Responsibilities

• 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.
• Lead the development of clinical trial protocols with a focus on medical aspects, including patient eligibility criteria, treatment plans, and dosing strategies.
• Collaborate closely with Pharmacovigilance (PV) to monitor patient safety and manage risk mitigation strategies.
• Review, interpret, and report clinical trial data from a medical perspective to assess drug efficacy and safety.
• Interact with regulatory authorities and ethics committees, providing medical insights during submissions and addressing scientific or medical concerns.
• Support Therapeutic Area (TA) Heads in external medical communications directed at healthcare professionals, clinical investigators, and regulatory bodies.
• Collaborate with Product Management (PM) and Business Development (BD) teams to assess new opportunities and provide medical validation for potential assets or partnerships.

Requirements

• MD required; PhD or comparable education a plus.
• Experience with IND, NDA, BLA, or MAA submissions and approvals.
• Background in biotech or pharmaceutical industry.
• Prior industry experience in contributing to the preparation of clinical protocols, study reports, IND, IB, NDA/CTD documents.
• Prior industry experience in interactions and support of Medical Affairs and Commercial groups and activities.
• At 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 role.
• Experience in GI preferred.
• Solid understanding of Phase I – III drug development.

Skills

• Strong project management and excellent communication and negotiation skills.
• Ability to lead cross-functional teams in a matrix organization.
• Strong collaborative skills and strategic thinking.
• Strong scientific and analytical skills.
• Entrepreneurial, 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.
• Genuine passion for science and making a difference in patients' lives.
• Experience with emerging technologies (e.g., AI in trial design, real-world evidence).

Benefits

• Competitive salary.
• Comprehensive benefits.
• Extensive opportunities for professional growth and development.

We foster a culture where innovation is key to success, value diversity, and welcome individuals with unique perspectives and experiences. Our commitment to people and patients is at the heart of everything we do.