Executive Medical Director, Hematology & Development

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 individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles),to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay(as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and Date Posted 02-Mar-2026 Closing Date 28-Jun-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. #J-18808-Ljbffr Dormont Manufacturing Co