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

Kyowa Kirin • Princeton, NJ

96d • $240,000 - $270,000 • Hybrid

About The Position

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. 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.

Requirements

• Medical Doctor (MD) degree from an accredited institution in the U.S. or a recognized foreign equivalent is required.
• Completed a sub-specialty in Medical Oncology with strong clinical training in Hematology and be Board Certified or Board Eligible.
• Minimum seven (5) years of experience in hematology/oncology clinical development within the biotech or pharmaceutical industry with track record in early phase development.
• Direct experience in functions affiliated with clinical development, including early-phase clinical trials.
• Proven track record in leading multicenter, global clinical trials in hematology, including extensive hands-on in medical monitoring.
• Strong understanding of the end-to-end drug development process.
• Understanding related disciplines such as statistics, regulatory, pre-clinical, pharmacology.
• Demonstrated scientific productivity in abstracts and publications.
• Ability to defend the clinical plan at governance is essential.
• Demonstrated history of effective leadership, including cross-functional and matrixed teams as well as seeking and maintaining alignment with cross-functional leaders.
• Demonstrated ability to work effectively in multicultural, global environments.
• Proven Passion and commitment to helping hematology patients is a must.

Nice To Haves

• Expertise in clinical development across all hematologic malignancies and most innovative asset platforms.
• Hands-on experience with small molecule, biologics, cell and gene therapy drug development.
• Strong knowledge of GCP, ICH guidelines, clinical trial design, biostatistics, and the global regulatory and clinical development process.
• Proven ability to support and contribute to regulatory submissions (INDs, NDAs, BLAs) and engage with global regulatory authorities.
• Demonstrated success in leading and collaborating across global, cross-functional teams.
• In-depth knowledge of molecular oncology, translational science, and biomarkers in clinical development.
• Experience specifically in Multiple Myeloma, is highly desirable.
• Familiarity with emerging therapeutic modalities, including next-generation cell and gene therapies.
• Experience working with investigator-sponsored trials (ISTs) or academic collaborations.
• Demonstrated ability to contribute to scientific strategy, including publications, congress presentations, and external scientific engagement with KOLs.
• Excellent written, verbal, and listening communication skills: articulate and effective communicator and presenter.
• Proficiency in Microsoft Office Suite (Excel, Word, Outlook, etc.).

Responsibilities

• Lead, develop and execution 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
• 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.
• 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
• 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.
• 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.
• 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 academic collaborators.

Benefits

• 401K with company matching
• Discretionary Profit Sharing
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Long-Term Incentives
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees