Senior Manager, Clinical Management – Early Phase, Immunology/Auto-immune

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $150k - $224.3k / year

⏰ Full Time

🟠 Senior

👔 Manager

👻 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

• Oversee and manage early-phase (P1–2a) clinical studies • Plan, execute, and complete clinical trials according to applicable regulations, ICH/GCP, and Otsuka SOPs • Contribute to development and review of clinical study documents, protocols, and informed consent forms • Provide input into identification, evaluation, and selection of CROs, outside vendors, and investigative sites • Lead and guide the clinical team to complete study activities compliantly • Communicate and coordinate project activities and progress across cross-functional departments • Provide management with updates on scope, schedule, and resources • Participate in forecasting study expenditures and resourcing needs • Ensure study budgets and expenses remain within forecast and communicate variances • Establish communication flows with CROs and investigative sites to maximize protocol compliance • Oversee ESP day-to-day trial operations • Review clinical trial data for data integrity, trends, and consistency • Support inspection readiness and ensure TMF completeness, timeliness, and quality • Represent Clinical Management in protocol reviews and departmental or cross-functional initiatives • Participate in program- and study-level risk mitigation activities • Lead or contribute to standardization and continuous improvement efforts • Coordinate training and onboarding of new employees when assigned • Set performance expectations and development plans and provide employee feedback when assigned • Perform other assigned duties

🎯 Requirements

• Ability to oversee complex First in Human SAD/MAD/POC trials in immunology/autoimmune indications • Comprehensive knowledge of clinical operations, drug development processes, project team roles and responsibilities, SOPs, and GCP/ICH regulations • Thorough knowledge of CROs, outsourcing, and evaluating work against vendor Statements of Work (SOW) • Strong understanding of the clinical and scientific basis for the assigned clinical program, with ability to translate that knowledge into operational management • Strong understanding of global regulatory requirements • Strong communication, organization, planning, analytical, problem-solving, and people management skills • Demonstrated experience with Microsoft programs including Word, Excel, PowerPoint, and Outlook • Good understanding of clinical trial software including eCRFs, IRT, and CTMS • Ability to travel up to 25% • Bachelor’s Degree or Registered Nurse (RN) • Minimum of 10 years of industry experience, including seven years in clinical trial management experience

🏖️ 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