Make your mark for patients

We are looking for a Head of Medical, US Rare Disease who has expertise in Medical Affairs, can lead a multi-cultural setting, and is patient focused to join us in our Rare Disease Organization (RDO)US team, based in our home offices in Smyrna, GA.

About the role

The Head of Medical, US Rare Diseases serves as the senior medical affairs leader for all rare disease products and indications in the US, including late-stage development molecules and indications, as well as those currently marketed.

With respect to medical affairs activities that may impact or support regulatory filings, the HMRD maintains supervisory and budgetary oversight for US medical input into late-stage registration trials (Phase 3/Phase 3b), Compassionate Use/Expanded Access programs, Risk Evaluation & Mitigation Strategies (REMS) programs, US labeling, and review and approval of clinicaltrials.gov trial listings and other transparency requirements.

The HMRD also holds responsibility for supporting the co-development and maintenance of all US Medical Affairs SOPs and supporting documents impacting internal and field based medical affairs employees.

Who you’ll work with

• You will lead a team of six first line leaders, including two Field Medical Leads, two Medical Strategy Leads, one Rare Population Health Lead, and one Medical Strategic Operations Lead.
• Global Medical Affairs Leadership and committees
• Chair of the Steering Committee for ZILBRYSQ REMS program
• RDO Commercial Leadership
• US Medical Affairs community

What you’ll do 

• Shares responsibility for reviewing and approving study‑related documents, including clinical study reports, statistical analysis plans, and clinical protocols.
• Leads a diverse U.S. Medical Affairs organization supporting scientific communication, engagement, and evidence‑generating research.
• Overseas medical affairs budget planning, reforecasting, and reconciliation.
• Ensures annual medical affairs plans align with the Integrated Strategic Plan and key global/regional success factors.
• Supervises training and development initiatives for U.S. medical affairs team members.
• Provides coaching and leadership to medical affairs leaders overseeing internal and field‑based medical teams.
• Serves as U.S. representative to global committees, offering insight on pre‑launch and launch strategies, policies, and evidence‑generation planning.
• Guides governance related to medical affairs policies, talent development, and strategic execution across medical functions.
• Chairs the ZILBRYSQ REMS Steering Committee and acts as the main medical contact for audits and inspections.
• Ensures oversight of day‑to‑day REMS operations, including vendor management, RIT coordination, and timely FDA information responses.
•  

Interested? For this role we’re looking for the following education, experience and skills

Required

• Doctoral degree (PhD, MD, or PharmD required)
• Minimum 10+ years of medical affairs experience in biopharmaceuticals
• Minimum 5+ years of management experience with a proven track record of leading high-performing teams
• Ability to travel domestically and internationally at a minimum of 40%

Preferred

• Specific expertise in medical affairs, strategic planning and execution
• Expertise/experience in the development of medical affairs standard operating
• Expertise/experience in US regulatory requirements for NDAs, and post-marketing requirements for compliant medical affairs support
• procedures and organizational leadership in alignment with said SOPs
• Expertise in a scientific and clinical field, with leadership experience integrating clinical evidence into organizational priorities and tactics, with clear direction for execution by various medical affairs roles. Patient experience highly preferred. Clinical or research experience in Neurology 

Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities. 

Unless explicitly stated in the description, this role is hybrid with 40% of your time spent in the office, regardless of your current contractual agreement. If your current working arrangements differ, please contact your Talent Partner to discuss before submitting your application.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable federal, state, or local law. UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment, your employment with UCB, or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws, orders, and regulations.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

Requisition ID: 92051  

Recruiter: Mary Fagundo  

Hiring Manager: Kimberly Moran  

Talent Partner: Robert Way

Job Level: E II 

Please consult HRAnswers for more information on job levels.