Strategic Director Global Clinical Programs

Otsuka America Pharmaceutical Inc.; Augusta (ME); On-site; USD 186,000 - 279,000; Full time

Benefits offered by this job

Comprehensive medical

Dental

Vision

Prescription drug coverage

Life insurance

AD&D

Disability insurance

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

Paid holidays

Paid leave programs

Job summary

Otsuka America Pharmaceutical Inc. seeks a Director to oversee operational strategy and management of clinical programs in collaboration with senior leadership. Responsibilities span regulatory compliance, development planning, budgeting, and cross-functional execution across ESPs and internal departments.

The role emphasizes leadership in program teams, strategic partnerships, and regulatory submissions, with a focus on data integrity and timely delivery of clinical objectives.

Qualifications

• Comprehensive knowledge of clinical operations, drug development, SOPs, GCP/ICH regulations.
• Thorough knowledge of CROs, outsourcing, and vendor evaluation against SOW.
• Advanced understanding of drug development and trial management.

Responsibilities

• Provide scientific clinical research and operational expertise for GCDP strategy.
• Represent Clinical Management in development of the Clinical Development Plan, timelines, and budget.
• Ensure standards (CRFs, training, templates) are applied across studies for dossier consistency.
• Contribute to clinical trial reports, publications, and internal/external presentations.
• Develop program-level financial estimates and MLTP contributions.
• Lead program-level teams as Co-Chair or lead clinical management representative in meetings.
• Prepare regulatory documents and ensure inspection readiness where appropriate.
• Build scientific partnerships with advisors to optimize study design and reporting.
• Support design and implementation of program-level HEOR strategy.
• Serve as Medical Affairs contact for medical information and disclosures.

Skills

Clinical operations

GCP/ICH compliance

CRO management

Medical writing

Biostatistics

Data management

Leadership

Communication

Education

Bachelor’s Degree

Tools

eCRFs

IRT

CTMS

Excel

Job description

Otsuka America Pharmaceutical Inc. seeks a Director to oversee operational strategy and management of clinical programs in collaboration with senior leadership. Responsibilities span regulatory compliance, development planning, budgeting, and cross-functional execution across ESPs and internal departments.

The role emphasizes leadership in program teams, strategic partnerships, and regulatory submissions, with a focus on data integrity and timely delivery of clinical objectives.