Senior Medical Director, Clinical Development Leader- GI (Remote)

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

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 strategies
• Collaborate closely with Pharmacovigilance (PV) to monitor patient safety throughout the trials and manage risk mitigation strategies
• Review, interpret, and report clinical trial data from a medical perspective to accurately assess the drug’s efficacy and safety profile

Regulatory & External Engagement:

• Interact with regulatory authorities and ethics committees, providing essential medical insights during submissions and addressing any scientific or medical concerns
• Support Therapeutic Area (TA) Heads in external medical communications directed at healthcare professionals, clinical investigators, and regulatory bodies

Business 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 partnership

Who are you:

• 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

Core 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 thinker
• 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.
• A genuine passion for science and in making a difference in patient's lives
• Experience 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.

Alfasigma USA, Inc. is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee on the basis of race, religious creed, religious observance, color, age, sex, sexual orientation, gender, gender identity, gender expression, genetic information, national origin, ancestry, marital status, medical condition as defined by state law (cancer and genetic characteristics), disability, military service, military and veteran status, pregnancy, childbirth and related medical conditions, or any other classification protected by federal, state, and local laws and ordinances. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing undue hardship on the Company. Please email Human Resources at applicant@alfasigma.com if you need assistance completing any forms or to otherwise participate in the application process.