Executive Medical Director, Hematology

**Executive Medical Director, Clinical Development, Hematology** **Location:** Boston, MA **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. **Therapy 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. *The annual base pay for this position ranges from* 323,216.00 - 484,824.00 USD *Annual.* *Base pay offered may vary depending on multiple individualiz…