Head of Medical US Rare Diseases

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 Diseasesserves 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 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 youll 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 youll do

• Shares responsibility for reviewing and approving studyrelated documents including clinical study reports statistical analysis plans and clinical protocols.
• Leads a diverse U.S. Medical Affairs organization supporting scientific communication engagement and evidencegenerating 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 fieldbased medical teams.
• Serves as U.S. representative to global committees offering insight on prelaunch and launch strategies policies and evidencegeneration 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 daytoday REMS operations including vendor management RIT coordination and timely FDA information responses.

Interested For this role were looking for the following education experience and skills

• 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

This positions reasonably anticipated base salary range is $336000.00 - $441000.00 annually. The actual salary offered will take into account internal equity and may also vary depending on the candidates geographic region job-related knowledge skills and experience among other factors.

Are you ready to go beyond to create value and make your mark for patients If this sounds like you then we would love to hear from you!

About us
UCB is a global biopharmaceutical company focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe inspired by patients and driven by science.

Why work with us
At UCB we dont just complete tasks we create value. We arent afraid to push forward collaborate and innovate to make our mark for patients. We have a caring supportive culture where everyone feels included respected and has equal opportunities to do their best work. We go beyond to create value for our patients and always with a human focus whether thats on our patients our employees or our planet. Working for us you will discover a place where you can grow and have the freedom to carve your own career path to achieve your full potential.

At UCB weve embraced a hybrid-first approach to work bringing teams together in local hubs to foster collaborative curiosity. Unless explicitly stated in the description or precluded by the nature of the position roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity 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 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.