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 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 vi