Senior Director, Global Clinical Development

🕒 2 days ago

🇺🇸 United States – Remote

💵 $230.7k - $345k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 0%

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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 clinical development strategy and execution for assigned programs from proof of concept through late-stage trials and regulatory submissions • Provide medical and scientific leadership to cross-functional study teams • Ensure high-quality clinical trial design, conduct, and data interpretation • Serve as medical lead and subject matter expert for assigned indications • Ensure trials comply with GCP, regulatory requirements, and internal processes • Lead and contribute to clinical sections of INDs, IBs, clinical study reports, and NDAs/BLAs • Collaborate with regulatory affairs on interactions with global health authorities • Provide strategic and medical oversight to vendor and CRO relationships and governance committees • Lead clinical discussions with KOLs and advisory boards • Develop medical monitoring plans and asset development plans • Contribute to publication plans and review scientific manuscripts • Mentor and provide leadership to junior team members • Support business development through medical due diligence and evaluation of external opportunities • Contribute to corporate continuous process improvement initiatives

🎯 Requirements

• M.D. or D.O., preferably with an immunology, rheumatology, or dermatology background • Management experience, direct or indirect • Minimum of five years of clinical research experience post academia as a general guideline • Experience in the pharmaceutical industry, clinical practice, and/or academic translational clinical research • Thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines, including biostatistics, data management, and medical writing • Advanced understanding of clinical medicine and science • Advanced understanding of drug development principles and clinical trial implementation and management • Complete understanding of global regulatory requirements • Working knowledge of marketing and commercialization • Understanding of corporate goals and basic business principles • Demonstrated experience across developmental phases, including preclinical or in-licensing evaluation, early clinical safety and proof of concept, global registration trials, and late-stage life-cycle management • Demonstrated experience leading clinical aspects of regulatory interactions • Ability to work across therapeutic areas and stages of clinical development • Demonstrated ability to manage and motivate clinical team members, internal staff, and external investigators/consultants • Strong communication and presentation skills • Strong computer skills and demonstrated experience with Microsoft Word, Excel, PowerPoint, and Outlook • Working knowledge of immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical writing • Travel approximately 30–35%

🏖️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage • Company-provided basic life insurance • Accidental death and 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 • Incentive opportunity