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

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.

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
• Coordinate 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 academic collaborators

Education

Medical Doctor (MD) degree from an accredited institution in the U.S. or a recognized foreign equivalent is required. The ideal candidate will have completed a sub-specialty in Medical Oncology with strong clinical training in Hematology and be Board Certified or Board Eligible. A solid scientific foundation in hematology/oncology, along with knowledge or experience in biostatistics, is highly desirable.

Experience

• 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

Technical Skills

• 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.)

Working Conditions

This role operates in a global, cross‑functional environment and requires adaptive flexibility, including participation in early morning or evening virtual meetings to collaborate effectively with international teams and study sites across multiple time zones. The position follows a hybrid work model, with an expected on‑site presence of two days per week or eight days per month, supporting a balance between purposeful in‑person collaboration and personal flexibility. Additionally, the role requires up to 35% domestic and international travel to support global clinical studies and engage with regional teams and key stakeholders.

Salary

The anticipated salary for this position will be $310,000 to $340,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job‑based knowledge, location, and other business and organizational needs).

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)
• Well‑Being and Work/Life Programs
• Long‑Term Incentives
• Life & Disability Insurance
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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