Strategic Director, Clinical Programs & Operations

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

Benefits offered by this job

Comprehensive medical

Dental

Vision

401(k) match

Flexible time off

Paid holidays

Job summary

Otsuka America Pharmaceutical Inc. seeks a Director to drive the operational strategy and management of clinical programs in collaboration with the Senior Director of Clinical Management.

You will coordinate with internal departments and ESPs, ensuring adherence to ICH, GCP, and Otsuka SOPs within agreed timelines and budgets. You will influence GCDP development, oversee trial design and reporting, manage program budgets, and lead cross-functional teams in regulatory submissions and HEOR

Qualifications

• Comprehensive knowledge of clinical operations, drug development, SOPs and GCP/ICH regulations.
• Thorough knowledge of CROs, outsourcing, and vendor SOW evaluation.
• Advanced understanding of drug development principles and trial management.
• Strong regulatory, biostatistics, data management and medical writing knowledge.
• Excellent communication, organization, planning, analytical and people management skills.
• Proficiency with Microsoft Office and trial software (eCRFs, IRT, CTMS).
• Ability to travel up to 25%.

Responsibilities

• Provides scientific clinical research and operational input for the Global Clinical Development Plan (GCDP).
• May assist in development of Clinical Development Plan timelines and budgets for Business Development opportunities.
• Ensures program standards (CRFs, SOWs, templates) are applied across studies for consistent dossiers.
• Contributes to clinical trial reports, publications and presentations.
• Develops program-level financial estimates and MLTP contributions.
• Leads program-level teams as Co-Chair or lead clinical management representative for meetings.
• Prepares regulatory documents (IB/IND/CTA submissions, annual reports) and supports labeling teams.
• Drives HEOR strategy development and endpoint planning where needed.
• Acts as Medical Affairs contact for information requests and publications strategies.
• Represents programs to senior management and cross-functional partners.

Skills

Clinical operations

GCP/ICH

SOPs

Regulatory compliance

Data management

Medical writing

Travel up to 25%

Education

Bachelor’s Degree + 14 years pharma experience

Tools

Microsoft Office

eCRFs

IRT

CTMS

Job description

Otsuka America Pharmaceutical Inc. seeks a Director to drive the operational strategy and management of clinical programs in collaboration with the Senior Director of Clinical Management.

You will coordinate with internal departments and ESPs, ensuring adherence to ICH, GCP, and Otsuka SOPs within agreed timelines and budgets. You will influence GCDP development, oversee trial design and reporting, manage program budgets, and lead cross-functional teams in regulatory submissions and HEOR