Senior Director, Global Clinical Development – Nephrology, Immunology

🕒 June 29

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• 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 • 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 and regulatory requirements • 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 • Develop clinical documents including medical monitoring plans and asset development plans • Mentor and provide leadership to junior team members within the organization • Support business development activities through medical due diligence and evaluation of external opportunities

🎯 Requirements

• A clinician (M.D., or D.O.) preferably with an immunology, rheumatology, or dermatology background including management experience (direct or indirect) • Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus • Minimum of five years of clinical research experience, post academia • Thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing) • Advanced understanding of drug development principles and clinical trial implementation and management • Complete understanding of the global regulatory requirements • Working knowledge of marketing and commercialization • Strong communication and presentation skills • Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)

🏖️ Benefits

• Comprehensive medical, dental, vision, prescription drug coverage • Company provided basic life, accidental death & dismemberment insurance • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Other company provided benefits