Kyowa Kirin, Inc.- U.S.
Senior Medical Director, Early Clinical Development Lead, Global Hematology/Onco
Kyowa Kirin, Inc.- U.S., Princeton, New Jersey, us, 08543
Overview
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 requires deep expertise across the global drug development continuumfrom early discovery through go/no go decisions and understanding late-stage clinical trials. This role provides strategic direction and long-term guidance on all clinical aspects, including first-in-human, dose-escalation, proof-of-concept, and Phase IIII trials, and is responsible for shaping and executing comprehensive early clinical development strategies aligned with Target Medicine Profiles (TMPs) and Integrated Evidence Plans (IEPs) across all development phases. Responsibilities
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. Collaborate with Biomarkers Groups to develop and evaluate pharmacodynamic and biomarker plans. Support projects from Research to Proof of Concept and transition molecules to late-stage development (post-POC). Collaborate with preclinical and discovery research to translate into therapeutic candidates. Coordinate with BD to support external collaboration and cultivate new research and projects. Ensure clinical components of 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 multiple clinical programs and provide cross-project consultation. Oversee medical monitoring to ensure trials are conducted per protocols, regulatory requirements, and patient safety standards. Lead medical data review and interpretation to assess safety signals and study outcomes. Provide medical leadership to early-stage clinical scientists on the study team in a matrix environment with other clinical, statistics, and translational groups. Serve as Medical Monitor and primary medical contact for assigned projects and trials. Ensure ongoing safety surveillance in collaboration with the pharmacovigilance team, including participation in safety reviews 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 (INDs, NDAs, BLAs, IBs, 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 trial success and data analysis; support site training and respond to medical queries from investigators, CROs, and internal teams. Cultivate and maintain relationships with key opinion leaders (KOLs), investigators, and academic collaborators. Qualifications
Education : Medical Doctor (MD) from an accredited institution; sub-specialty in Medical Oncology with strong hematology training; Board Certified or Board Eligible. Strong scientific foundation in hematology/oncology; knowledge or experience in biostatistics is desirable. Experience : Minimum seven (5) years of hematology/oncology clinical development experience in biotech/pharma with a track record in early-phase development; direct experience in early-phase clinical trials; leadership of multicenter, global hematology trials with hands-on medical monitoring; understanding of end-to-end drug development; collaboration across cross-functional teams and global environments; demonstrated scientific productivity; demonstrated ability to defend clinical plans at governance; passion for helping hematology patients. Technical Skills : Expertise in clinical development across hematologic malignancies and innovative asset platforms; experience with small molecules, biologics, cell and gene therapies; strong knowledge of GCP/ICH, trial design, biostatistics, and global regulatory processes; ability to contribute to regulatory submissions and engage with regulatory authorities; knowledge of molecular oncology, translational science, and biomarkers; experience with Multiple Myeloma is highly desirable; familiarity with emerging modalities including next-generation cell and gene therapies; experience with ISTs or academic collaborations; strong scientific communication, publications, and external engagement with KOLs; proficiency with Microsoft Office. Working Conditions
This role operates in a global, cross-functional environment with flexibility for early morning or evening virtual meetings across time zones. It follows a hybrid work model with on-site presence of two days per week or eight days per month, and up to 35% travel domestically and internationally to support global studies and stakeholder engagement. Compensation and Benefits
The anticipated salary for this position is $315,000 to $330,000. Actual salary offered will vary based on experience, qualifications, location, and other business needs. The compensation package includes a comprehensive benefits program, such as: 401K with company matching Discretionary profit sharing Annual bonus program (sales bonus for sales roles) Generous PTO and holiday schedule Healthcare benefits (medical, dental, prescription drugs, vision) Well-being and work/life programs Long-term incentives Life & disability insurance Pet insurance Tuition assistance Employee referral awards Equal Employment Opportunity and Privacy
Kyowa Kirin North America is an equal opportunity employer. We do not discriminate on any protected status. Your personal data will be collected and stored for recruitment purposes in compliance with applicable privacy laws. If located outside the United States, data may be transferred to the U.S. for recruitment processing. For more information about data processing and your rights, contact us via the general recruitment channels. Recruitment & Staffing Agencies
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #J-18808-Ljbffr
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 requires deep expertise across the global drug development continuumfrom early discovery through go/no go decisions and understanding late-stage clinical trials. This role provides strategic direction and long-term guidance on all clinical aspects, including first-in-human, dose-escalation, proof-of-concept, and Phase IIII trials, and is responsible for shaping and executing comprehensive early clinical development strategies aligned with Target Medicine Profiles (TMPs) and Integrated Evidence Plans (IEPs) across all development phases. Responsibilities
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. Collaborate with Biomarkers Groups to develop and evaluate pharmacodynamic and biomarker plans. Support projects from Research to Proof of Concept and transition molecules to late-stage development (post-POC). Collaborate with preclinical and discovery research to translate into therapeutic candidates. Coordinate with BD to support external collaboration and cultivate new research and projects. Ensure clinical components of 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 multiple clinical programs and provide cross-project consultation. Oversee medical monitoring to ensure trials are conducted per protocols, regulatory requirements, and patient safety standards. Lead medical data review and interpretation to assess safety signals and study outcomes. Provide medical leadership to early-stage clinical scientists on the study team in a matrix environment with other clinical, statistics, and translational groups. Serve as Medical Monitor and primary medical contact for assigned projects and trials. Ensure ongoing safety surveillance in collaboration with the pharmacovigilance team, including participation in safety reviews 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 (INDs, NDAs, BLAs, IBs, 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 trial success and data analysis; support site training and respond to medical queries from investigators, CROs, and internal teams. Cultivate and maintain relationships with key opinion leaders (KOLs), investigators, and academic collaborators. Qualifications
Education : Medical Doctor (MD) from an accredited institution; sub-specialty in Medical Oncology with strong hematology training; Board Certified or Board Eligible. Strong scientific foundation in hematology/oncology; knowledge or experience in biostatistics is desirable. Experience : Minimum seven (5) years of hematology/oncology clinical development experience in biotech/pharma with a track record in early-phase development; direct experience in early-phase clinical trials; leadership of multicenter, global hematology trials with hands-on medical monitoring; understanding of end-to-end drug development; collaboration across cross-functional teams and global environments; demonstrated scientific productivity; demonstrated ability to defend clinical plans at governance; passion for helping hematology patients. Technical Skills : Expertise in clinical development across hematologic malignancies and innovative asset platforms; experience with small molecules, biologics, cell and gene therapies; strong knowledge of GCP/ICH, trial design, biostatistics, and global regulatory processes; ability to contribute to regulatory submissions and engage with regulatory authorities; knowledge of molecular oncology, translational science, and biomarkers; experience with Multiple Myeloma is highly desirable; familiarity with emerging modalities including next-generation cell and gene therapies; experience with ISTs or academic collaborations; strong scientific communication, publications, and external engagement with KOLs; proficiency with Microsoft Office. Working Conditions
This role operates in a global, cross-functional environment with flexibility for early morning or evening virtual meetings across time zones. It follows a hybrid work model with on-site presence of two days per week or eight days per month, and up to 35% travel domestically and internationally to support global studies and stakeholder engagement. Compensation and Benefits
The anticipated salary for this position is $315,000 to $330,000. Actual salary offered will vary based on experience, qualifications, location, and other business needs. The compensation package includes a comprehensive benefits program, such as: 401K with company matching Discretionary profit sharing Annual bonus program (sales bonus for sales roles) Generous PTO and holiday schedule Healthcare benefits (medical, dental, prescription drugs, vision) Well-being and work/life programs Long-term incentives Life & disability insurance Pet insurance Tuition assistance Employee referral awards Equal Employment Opportunity and Privacy
Kyowa Kirin North America is an equal opportunity employer. We do not discriminate on any protected status. Your personal data will be collected and stored for recruitment purposes in compliance with applicable privacy laws. If located outside the United States, data may be transferred to the U.S. for recruitment processing. For more information about data processing and your rights, contact us via the general recruitment channels. Recruitment & Staffing Agencies
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #J-18808-Ljbffr