Director, Global Clinical Development

🔥 0 minutes ago

🏖️ New Jersey, Maryland – Remote

🏖️ New Jersey – Remote 🦀 Maryland – Remote

💵 $209.6k - $313.4k / year

⏰ Full Time

🔴 Lead

👔 Director

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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

• Design and oversee clinical research programs and protocols for OPDC products under GCP • Evaluate and support clinical development of Rare Diseases, Inherited Metabolic Diseases, and Specialty Medicine products at different development stages • Consult with patients or representatives and clinical, regulatory, and scientific leaders to optimize trial objectives, designs, and protocols • Serve as a clinical/medical scientific consultant to health economic, medical affairs, marketing, regulatory, statistical, and research project teams and external regulatory agencies • Author program strategies such as GDCP and oversee trials assessing safety, efficacy, medical usefulness, and product value • Interpret and communicate Phase I–IV investigation results for new drug preparation • Act as signatory on NDA submissions and clinical study and safety documents • Contribute to product life-cycle management and identify strategic innovations • Provide strategic oversight of vendor and CRO relationships and clinical input to governance committees • Lead and support regulatory filing activities and documents • Provide strategic direction and editing for concise, clear, and convincing written and verbal communications

🎯 Requirements

• Required clinician qualification: M.D. or D.O., preferably a geneticist, metabolic physician, rare disease expert, or immunology specialist • Highly qualified candidates with other clinical/scientific doctorates may be considered when complemented by a team or consulting clinician • 3–6 years of pharmaceutical industry, clinical practice, or academic translational clinical research experience is typically required for Director level, depending on experience type • At least 5 years of involvement in clinical research or drug development in an academic or industry environment • Experience across clinical activities in Phases I through IV • Thorough knowledge of clinical medicine and science management • Ability to define critical objectives and deliver business outcomes on time, on budget, and with superior quality • Ability to communicate effectively in meetings and written and oral presentations • Facility with Microsoft Word, Excel, PowerPoint, and Outlook • Demonstrated experience leading, managing, and motivating internal staff and external investigators or consultants • Advanced understanding of drug development principles and clinical trial implementation, management, and reporting • Flexibility working across different therapeutic areas and stages of clinical development • Working knowledge of immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical writing • Complete understanding of global regulatory requirements

🏖️ Benefits

• Incentive opportunity • Comprehensive medical coverage • Dental coverage • Vision coverage • Prescription drug coverage • Company-provided basic life insurance • Accidental death & dismemberment insurance • Short-term disability insurance • 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