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 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 continuumfrom 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 IIII 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 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

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.

Requirements:

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.

The anticipated salary for this position will be$315000 to $330000. 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.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 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

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

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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