Senior Medical Director, Early Clinical Development Lead, Global Hematology/Oncology

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Senior Medical Director, Early Clinical Development Lead, Global Hematology/Oncology plays a critical role in advancing innovative therapeutics within Hematology/Oncology. This position demands deep expertise across the global drug development continuum—from early discovery through go/no decisions and understanding late-stage clinical trials. This position provides strategic direction and long-term guidance on all clinical aspects, including first-in-human, dose-escalation, proof-of-concept, and Phase I–III trials. In close collaboration with Strategic Functions, Project Leaders and Clinical Science, this role is responsible for shaping and executing comprehensive early clinical development strategies, ensuring alignment with Target Medicine Profiles (TMPs) and Integrated Evidence Plans (IEPs) across all phases of development.

Essential Functions:

The Senior Director, Early Clinical Development Lead, Global Hematology/Oncology plays a key leadership role in shaping clinical strategy and bridging early-stage science with late-stage development. This role provides strategic medical guidance across hematology clinical projects and ensures the highest standards of scientific and regulatory excellence.

Strategic and Clinical Leadership
•    Lead, develop and execute strategic development for early development across hematology assets
•    Provide medical leadership in the design, development, and implementation of clinical protocols and clinical development plans. 
•    Act as a subject matter expert (SME) for internal and external stakeholders, including regulators, investigators, and cross-functional teams.
•    Cross functional work Biomarkers Groups to develop and evaluate potential and predictive pharmacodynamic and biomarker plans
•    Support projects from Research to Proof of Concept at which point molecules may be handled to the late-stage development (post POC)
•    Collaborate with preclinical and discovery research to translate into therapeutic candidates
•    Coordinates with BD to support external collaboration and foster new research and projects

Study Design and Clinical Execution
•    Ensure clinical components of the clinical plans and medical expertise are provided to project teams, including medical monitoring of clinical trials
•    Collaborate with clinical scientists on study design, selection criteria, endpoints, and data collection. Typically work with at least 2 clinical programs or more and provide consultation across multiple research projects. 
•    Oversee medical monitoring, ensuring clinical trials are conducted in compliance with protocols, regulatory requirements, and patient safety standards.
•    Lead medical data review and interpretation to assess safety signals, trends, and overall study outcomes.
•    Provide medical leadership to early-stage clinical scientist on the clinical study team working in a matrix environment with other clinicians, statistics, and translational groups 

Medical Monitoring and Oversight
•    Serve as Medical Monitor and primary medical contact for assigned projects and clinical trials.
•    Ensure ongoing safety surveillance in collaboration with the pharmacovigilance team, including participation in safety review and data monitoring committees.
•    Conduct ongoing medical review of clinical data for consistency, integrity, and adherence to protocol.

Regulatory Strategy and Documentation
•    Partner with regulatory affairs to develop and review key regulatory documents including INDs, NDAs, BLAs, IBs, and CSRs.
•    Provide medical input in regulatory interactions and ensure high-quality clinical and safety content in submissions.
•    Support responses to health authorities and ethics committees as needed.

Cross-Functional and External Collaboration
•    Collaborate with clinical operations, regulatory, biostatistics, safety, and other cross-functional partners to ensure successful trial execution and data analysis.
•    Support site training and respond to medical queries from investigators, CROs, and internal teams.
•    Cultivate and maintain strong relationships with key opinion leaders (KOLs), investigators, and a