Senior Director, Global Clinical Development – Psychiatry and Neurology

🔥 11 minutes ago

🏖️ New Jersey, Maryland – Remote

🏖️ New Jersey – Remote 🦀 Maryland – Remote

💵 $250k - $388.1k / year

⏰ Full Time

🟠 Senior

👔 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 good clinical practices (GCP) • Evaluate and clinically develop CNS and Digital Medicine products at different development stages for a global healthcare market • Consult with patients or representatives, clinical, regulatory, and scientific leaders to optimize trial objectives, designs, development plans, and protocols • Serve as an internal medical/scientific consultant to health economics, medical affairs, marketing, regulatory, statistical, and research project teams, as well as external regulatory agencies • Author global development and commercialization plans, protocols, and study reports • Oversee trials assessing clinical safety, efficacy, medical usefulness, and product value • Interpret and communicate Phase I–IV investigation results in preparation for new drug submissions • Act as signatory on NDA submissions and clinical study and safety documents • Contribute to product lifecycle 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, providing strategic direction and editing • Collaborate across a matrixed organization to achieve clinical development and business objectives

🎯 Requirements

• M.D. or D.O.; preferably a psychiatrist or neurologist • Prior management experience, direct or indirect • 6–9 years of experience in the pharmaceutical industry or academic translational clinical research for Senior Director levels, depending on experience type • Thorough knowledge of clinical medicine and science management • Ability to communicate effectively in meetings and via written and oral presentations • Facility with Microsoft Word, Excel, PowerPoint, and Outlook • Demonstrated experience leading, managing, and motivating internal staff, external investigators, or consultants • Advanced understanding of drug development principles and clinical trial implementation, management, and reporting • Flexibility to work across different therapeutic areas and clinical development stages • Working knowledge of biostatistics, clinical pharmacology, formulation science, data management, and medical writing • Complete understanding of global regulatory requirements • Working knowledge of health value creation, including financial assessment, project planning and budgeting, market research, and commercialization strategies • Dedication to assigned projects and project goals in a compliant, regulated, matrixed business setting • Willingness to travel 30% of the time, including weekends, and ability to travel internationally

🏖️ 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

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