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

Alfasigma

8d•Remote

About The Position

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. 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.

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
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)

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 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.
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.
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.