Senior Director, Global Clinical Development Nephrology & Immunology

Senior Director, Global Clinical Development (GCD)

Otsuka is seeking an experienced and visionary Senior Director, Global Clinical Development (GCD), with experience in immunology, who will serve as a clinical leader responsible for the design, execution, and oversight of global clinical development programs. The successful candidate will play a key role in shaping the clinical strategy, leading cross-functional study teams, and ensuring the highest standards of scientific and medical integrity. The incumbent will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP). The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA, BLA, and / or Global filings.

Key Job Responsibilities :

• Lead the clinical development strategy and execution for assigned programs after proof of concept through late-stage trials and regulatory submissions.
• Provide medical and scientific leadership to cross-functional study teams and ensure high-quality clinical trial design, conduct, and data interpretation.
• Serve as the medical lead and subject matter expert for assigned indications.
• Partner with cross-functional team to ensure trials are conducted in compliance with GCP, regulatory requirements, and internal processes.
• Lead and contribute to development of clinical sections of regulatory documents, including INDs, IBs, clinical study reports, and NDAs / BLAs.
• Collaborate with regulatory affairs on interactions with global health authorities.
• Provides strategic and medical oversight to vendor and CRO relationships and provides clinical input into their governance committees.
• Lead clinical discussions with KOLs and advisory boards.
• Develop clinical documents including medical monitoring plans, asset development plans
• Contribute to development of publication plans and review scientific manuscripts for publications.
• Mentor and provide leadership to junior team members within the organization.
• Support business development activities through medical due diligence and evaluation of external opportunities.
• Contributes to corporate initiatives by participating in continuous process improvement to meet company

Knowledge, Skills, Competencies, Education, and Experience :

Physical Demands and Work Environment :

See document Physical Demands and Work Environment for further requirements.

Competencies :

Salary Range : $245,454.00 - $381,110.00, plus incentive opportunity.

Application Deadline : This will be posted for a minimum of 5 business days.

Company benefits : Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, 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, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .

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