Senior Director of Clinical Development in Nephrology &...

Company Background/Culture Otsuka is a prestigious global healthcare organization committed to delivering groundbreaking health solutions. Our mission, "Otsuka people creating new products for better health worldwide," fuels our research and development initiatives. We focus on pharmaceuticals that tackle intricate diseases, especially in Neuroscience, Nephrology, and Immunology. Culture With over a century of history, Otsuka champions a distinctive culture that values creativity and accountability. Our philosophy inspires us to push limits and innovate, striving to answer unmet medical needs. We promote self-actualization, motivating our team to exceed expectations and embrace new responsibilities. Pipeline Since 2007, OPDC has been dedicated to developing transformative drug candidates, managing everything from clinical trial operations to regulatory approval strategies. Working closely with Otsuka America Pharmaceutical, Inc., we implement global strategies for product registration, continually expanding our impressive pipeline. Job Description Position Summary Otsuka is seeking a passionate and experienced Senior Director of Clinical Development with a robust background in immunology to spearhead our clinical development initiatives. In this pivotal role, you will design, execute, and oversee global clinical programs, define clinical strategies, and lead interdisciplinary teams while upholding the highest standards of medical and scientific integrity. Your leadership will guide clinical research from early phases through to post-commercialization. This position necessitates extensive knowledge of the drug development lifecycle, encompassing the management of large-scale global clinical trials and regulatory submissions. Key Job Responsibilities Lead the development strategy and execution for assigned programs from proof of concept through late-stage trials and regulatory submissions. Provide medical and scientific leadership across study teams to ensure top-quality clinical trials. Act as the medical lead and subject matter expert for designated indications. Ensure compliance with GCP, regulatory requirements, and internal processes across trials. Contribute to the development of clinical sections in regulatory documents, including INDs, clinical study reports, and NDAs/BLAs. Collaborate closely with regulatory affairs on interactions with global health authorities. Strategically oversee vendor and CRO relationships, providing clinical insights within their governance committees. Facilitate discussions with key opinion leaders and advisory boards. Develop clinical documents, including monitoring plans and development plans. Assist in creating publication plans and reviewing scientific manuscripts. Mentor and provide leadership to junior team members. Support business development activities through medical due diligence and opportunity evaluations. Contribute to corporate initiatives aimed at continuous process enhancement. Knowledge, Skills, Competencies, Education, and Experience Required: A clinician (M.D. or D.O.) with expertise in immunology, rheumatology, or dermatology, augmented by relevant management experience. Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are desirable. At least five years of experience in clinical research within the pharmaceutical industry or academia. In-depth knowledge of clinical medicine and pharmacology, biostatistics, data management, and medical writing. Comprehensive understanding of drug development and clinical trial management. Familiarity with global regulatory requirements. Insight into marketing and commercialization principles. Proven experience in effectively managing clinical team members. Exceptional communication and presentation skills. Advanced proficiency in Microsoft Office Suite. Strong grasp of drug development principles; flexibility in therapeutic areas is a plus. Physical Demands and Work Environment Travel requirement: Approximately 30-35%. Competencies Accountability for Results: Concentrate on strategic objectives and performance standards. Strategic Thinking & Problem Solving: Make decisions with long-term impacts in mind. Patient & Customer Centricity: Prioritize stakeholder needs. Impactful Communication: Communicate clearly and respectfully to influence outcomes. Respectful Collaboration: Appreciate diverse perspectives to achieve common goals. Empowered Development: Pursue professional growth as a fundamental business necessity. Compensation: Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunities. Actual compensation may vary based on experience and qualifications. Application Deadline: Applications will be accepted for at least 5 business days. Company Benefits: Comprehensive medical, dental, vision, and life insurance, tuition reimbursement, generous 401(k) match, flexible time off, paid holidays, and additional benefits. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply without regard to race, color, sex, gender identity, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran needing reasonable accommodations, please contact us.

Created: 2026-03-10