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

🕒 August 31

🇺🇸 United States – Remote

💵 $150k - $224.3k / year

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 1%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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