Medical Director, Medical Affairs

Job Summary:

The Medical Director, Medical Affairs is a senior therapeutic and disease area expert who serves as the organization's primary external medical and scientific expert for healthcare providers (HCPs), key medical experts (KMEs), clinical investigators (together with development and patient advocacy organizations. This role operates at the intersection of scientific leadership and external engagement — building and sustaining trusted peer-level relationships within the I&I community while driving the development and execution of the organization's medical affairs strategy for its assigned program strategy in lupus and broader I&I portfolio. The Director leads scientific exchange, supports evidence generation, shapes medical education and KME engagement programs, and serves as a senior internal scientific authority — providing medical input to clinical development, commercial readiness, market access, and regulatory strategy. Reporting to the Executive Director, Medical Affairs, this individual brings deep scientific expertise in autoimmune disease, strong KME relationship management, and the strategic leadership presence required to drive the medical affairs function forward in a clinical-stage, resource-efficient biotech environment.

Work Arrangement & Location:

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

Essential Duties and Responsibilities:

• Serve as the primary medical and scientific point of contact for KMEs, HCPs-, and patient advocacy groups within the I&I therapeutic area — with a primary focus on lupus (SLE and/or CLE), rheumatology, and dermatology — building and sustaining trusted, peer-level relationships that advance the organization's scientific and medical objectives.
• Define and lead the execution of the medical affairs strategy for the I&I pipeline, including lupus indications — encompassing KME engagement, evidence generation, medical education, advisory board programming, and publication support — in alignment with clinical development
• Lead and conduct peer-to-peer scientific exchange with KMEs, investigators, and HCPs together with the development team— sharing clinical and emerging data, discussing unmet medical needs, and gathering external insights (such as in depth knowledge of the patient journey from diagnosis to treatment along with barriers that are encountered along the way) that inform medical strategy, pipeline positioning, and commercial readiness.
• Monitor and critically assess competitive clinical data and emerging mechanisms to inform differentiation and scientific positioning.
• Lead the design and execution of medical advisory board meetings — identifying and engaging the right scientific experts, developing scientifically rigorous agendas, and ensuring that advisory board insights translate into actionable medical and strategic recommendations.
• Oversee the development and review of medical content — including medical education materials, scientific slide decks, congress abstracts, posters, and manuscripts — ensuring scientific accuracy, regulatory compliance, and strategic alignment across all external communications.
• Lead scientific engagement strategy for major rheumatology congresses, including KME interactions, data communication planning, and insight capture.
• Partner with Field Medical Affairs and MSL teams to ensure accurate, balanced, and up-to-date scientific tools and resources are available and consistently applied in field engagements — participating directly in key field interactions when the scientific complexity or stakeholder importance warrants senior medical presence.
• Provide strategic medical input into clinical development programs, partnering with development discussing trial design considerations (e.g., endpoints, patient selection, biomarkers), data interpretation, and differentiation versus emerging therapies.
• Collaborate with Clinical Development, Biostatistics, Regulatory Affairs, and other departments on the medical interpretation of clinical data, regulatory submissions, payer engagement strategies, and commercial launch planning — serving as a medical affairs voice across all key cross-functional initiatives.
• Perform other duties and responsibilities as assigned

Qualifications:

• Education: Advanced clinical degree (MD or DO) preferred or PhD in immunology. Board certification or clinical training in rheumatology, nephrology dermatology, immunology, or a related specialty strongly preferred. Additional advanced degree (PhD, MPH, or MBA) is a plus.
• Minimum of 5 years of combined clinical and/or pharmaceutical/biotech industry experience preferred
• Direct experience managing or advising lupus clinical programs strongly preferred.
• Deep scientific expertise in autoimmune disease — specifically lupus (SLE and/or CLE), rheumatology, and/or nephrology — required.
• Established KME network within the lupus and rheumatology community strongly preferred.
• Demonstrated track record of developing and executing medical affairs strategies, leading advisory boards, driving publication programs, and managing complex external stakeholder relationships in a clinical-stage biotech or pharmaceutical organization preferred.
• Deep clinical and scientific expertise in immunology and inflammation — with primary depth in lupus nephritis, SLE, and/or CLE — including command of disease mechanisms, clinical trial landscapes, standard of care evolution, regulatory developments, and emerging therapeutic approaches.
• Demonstrated ability to critically evaluate, synthesize, and communicate complex clinical and scientific literature — including clinical trial data, real-world evidence, and regulatory data packages — to diverse internal and external audiences.
• Experience supporting regulatory strategy and operations a medical affairs perspective; familiarity with promotional review processes and compliance frameworks governing medical communications.
• Prior experience with advisory board design, scientific meeting planning, ISR program oversight, HEOR strategy, and external expert relationship management in a pharmaceutical or biotech medical affairs context.
• Leverage advanced analytics, data science, and emerging AI-enabled tools to enhance insight generation, evidence synthesis, and medical strategy development.
• Proven external relationship leader — builds and sustains trusted, long-term relationships with national and regional KMEs, clinical investigators, and patient advocacy organizations through scientific credibility, consistent follow-through, and genuine commitment to advancing medical knowledge.
• Influential cross-functional partner — drives alignment across Medical Affairs, Clinical Development, Regulatory, Commercial, and Market Access through strong scientific authority and the ability to translate medical insights into organizational action via clear, prioritized medical actions and strategic recommendations.
• Exceptional scientific and medical communicator — engages KMEs, investigators, HCPs, payers, and patient advocacy leaders in substantive, peer-level scientific dialogue with depth, balance, and clarity appropriate to each audience.
• Skilled presenter and medical content developer — prepares and delivers compelling presentations, advisory board materials, and scientific updates to external experts, cross-functional leadership, and executive audiences with precision and strategic framing.
• Position may require domestic and international travel up to 20%+ of time or more including overnight stay driven by business need