Executive Medical Director, Hematology

Role overview

Senior medical leader overseeing 2+ hematology programs from IND through Phase 3 (first-in-human, proof-of-concept, registrational) under the Therapeutic Area Head.

Provides medical leadership and mentorship to Medical Directors and Clinical Development Scientists; may serve as medical monitor.

Shapes therapeutic area and regulatory strategy; represents Clinical Development in global governance (GPT/GMT) and supports business development due diligence.

Treatment area focus

Rare hematologic and complement-mediated disorders (e.g., PNH, aHUS, cold agglutinin disease, immune-mediated cytopenias, bone marrow failure syndromes).

Deep expertise in hematologic pathophysiology, complement/coagulation biology, thromboinflammation, hemolysis, and relevant biomarkers (e.g., LDH, bilirubin, haptoglobin, reticulocyte count, CH50/AP50, sC5b-9, D-dimer, platelet counts).

Key responsibilities

• Lead clinical strategy, trial design, and endpoint selection (e.g., transfusion avoidance, hemoglobin stabilization, hemolysis control, thrombotic event rates, organ protection, PROs, health resource utilization).
• Direct cross-functional collaboration with Translational Medicine, Clinical Pharmacology, and Biostatistics on PD readouts, exposure–response, hierarchical testing, and multiplicity strategies; serve as medical expert for study teams and supervise medical monitors as needed.
• Define and manage product benefit–risk; oversee safety characterization relevant to hematology (e.g., infection risk with complement inhibition, cytopenias, bleeding/thrombosis) and partner with Safety on risk management plans (e.g., vaccination/prophylaxis, REMS where applicable).
• Drive external engagement with KOLs, patient advocacy groups, ASH/EHA, and transfusion networks; lead advisory boards; align programs with evolving orphan/rare disease regulatory pathways.
• Represent Clinical Development at governance and review committees; lead scientific communications and clinical components of regulatory and scientific documents (protocols, charters, CSRs, CTD clinical sections, white papers, regulatory responses, publications).
• Monitor scientific, competitive, and regulatory landscapes; integrate insights into clinical development plans and asset strategies.
• Support business development activities (due diligence, research collaborations) and selection of advisory board experts.
• Interpret complex hematology labs and biomarker kinetics to inform dose selection, go/no-go decisions, subgroup analyses, and regulatory narratives.

Qualifications

• Required: MD (or equivalent); 7+ years’ clinical development experience with global regulatory and product development exposure; proven track record designing and executing multinational trials; experience preparing for and attending FDA/other agency meetings; demonstrated leadership of cross‑functional teams and support for BD activities.
• Strongly preferred: Board certification or substantial clinical training in Hematology or Hematology/Oncology; expertise in rare hematologic diseases or complement/coagulation biology; authorship of hematology protocols and regulatory documents; engagement with hematology-focused regulators and participation in ASH/EHA scientific forums; familiarity with hematology-specific endpoints, biomarkers, and risk mitigation (e.g., meningococcal vaccination with complement inhibition).
• Desirable: PhD or advanced training; advanced therapy-area knowledge with ability to interpret and represent program-level data.

Work environment

Office-based role requiring ability to use a computer and digital communications, collaborate cross-functionally, problem-solve, and maintain availability during standard business hours.