Board Certified Medical Director - Early Clinical Development (Neuroimmunology)

Report to: CMO

Location: US (Remote)

Summary:

We are building a world-class auto immunology pipeline with our allogeneic CAR-T platform, which will move first-in-class therapeutics from POC to registered clinical trial in record time. This role will serve as the global Lead Physician for our core immunology assets and shape the entire early-phase strategy across MS, NMOSD, MG and other auto-immune indications.

Responsibilities:

• Serve as global Clinical Lead (Lead Physician) for neuro-immune and other auto-immune assets, accountable for strategy, timelines, budget and quality from IND through Phase I/II.
• Design, write and defend FIH and PoC protocols, IBs, IMPDs, DSURs, safety-management plans, SAPs and regulatory submissions (FDA pre-IND/IND, EMA, CTA).
• Provide hands-on medical monitoring, aggregate safety review, SAE assessment and signal-detection for studies in high-risk neuro-inflammatory populations.
• Lead cross-functional asset core teams (research, translational, CMC, biostats, regulatory, commercial) to integrate biomarkers, imaging endpoints and adaptive designs.
• Select, contract and manage global CROs, central labs, imaging cores and academic consortia; ensure GCP/ICH compliance and deliverables met on time and within budget.
• Represent the program to health authorities, IRBs, DSMBs, KOLs and patient-advocacy groups; author briefing documents and present data at scientific meetings.
• Continuously benchmark competitive landscape and translate emerging science into go/no-go and acceleration decisions.

Qualifications:

• Board-certified/eligible neurologist who has completed an ACGME-accredited neurology residency.
• Current, unrestricted medical license in at least one U.S. state; willingness to maintain license and act as study physician.
• 2 years post-training clinical practice as a treating neurologist with documented exposure to neuro-immune patient populations (e.g., MS, NMOSD, CIDP, MG, GBS).
• 3 years biopharma / biotech experience in early-phase neuro-immune drug development, including at least one program advanced from IND-enabling to pivotal stage.
• Demonstrated track record as Lead Physician (clinical lead on asset core team) accountable for IND, protocol design, investigator brochure, DSMB packages, safety reviews, and regulatory interactions (FDA pre-IND / EOP / CTA).
• Direct experience managing global CROs, central labs, imaging vendors and academic consortia; able to write protocols, SAPs and CSRs without heavy external writer support.
• Deep familiarity with GCP, ICH-E6(R2), FDA & EMA guidance on FIH/PoC studies, and safety reporting in high-risk neuro-immune populations.