Head of Medical US Rare Diseases

UCB•Atlanta, GA

14d•Hybrid

About The Position

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.

Requirements

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%

Nice To Haves

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

Responsibilities

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.