Senior Clinical Program Lead, Early-Phase Immunology

Otsuka America Pharmaceutical Inc.; Hartford (CT); Remote; USD 150,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) match

Paid holidays

Generous PTO

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Sr. Manager, Clinical Management for Early Phase immunology/autoimmune trials.

You will oversee planning, execution, and completion of studies, coordinating with CROs, ESPs, and internal teams to ensure regulatory compliance and timely delivery. You will lead cross-functional study activities, review critical documents, and manage budgets and resourcing. This role requires strong leadership, communication, and strategic problem-solving in a dynamic

Qualifications

• Ability to oversee complex First in Human SAD/MAD/POC trials in immunology/autoimmune indications.
• Thorough knowledge of clinical operations, drug development processes, GCP/ICH regulations.
• Experience with CROs, outsourcing, and vendor SOW evaluation.

Responsibilities

• Provide oversight and management of clinical studies per regulations and guidance.
• Contribute to development and review of clinical study documents (protocols, informed consent forms).
• Lead identification, evaluation, and selection of CROs, ESPs, and sites.
• Provide leadership to clinical teams to ensure activities meet GCP and SOPs.
• Communicate and coordinate cross-functional project activities and progress.
• Forecast study expenditures and resourcing needs; manage budget variances.
• Ensure TMF completeness, timeliness, and quality; support inspection readiness.
• Represent Clinical Management in reviews across portfolios and initiatives.

Skills

Clinical trial mgmt

GCP/ICH knowledge

Vendor management

Cross-functional leadership

Communication skills

Microsoft Office

Education

Bachelor’s Degree or RN

Tools

eCRFs

IRT

CTMS

Job description

Otsuka America Pharmaceutical Inc. is seeking a Sr. Manager, Clinical Management for Early Phase immunology/autoimmune trials.

You will oversee planning, execution, and completion of studies, coordinating with CROs, ESPs, and internal teams to ensure regulatory compliance and timely delivery. You will lead cross-functional study activities, review critical documents, and manage budgets and resourcing. This role requires strong leadership, communication, and strategic problem-solving in a dynamic