Senior Director, Clinical Trials Management

Company Overview

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan, with operations in the U.S. (Sumitomo Pharma America, Inc.). The company focuses on patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS.

The Senior Director, Clinical Trials Management is responsible for operational leadership and oversight for vaccine clinical programs, including strategy, conduct, planning, budget, resources, site management, monitoring, study coordination, vendor management, and operational support. The role provides strategic direction for clinical trials primarily in the U.S., Japan, Europe, and other assigned regions to ensure timely completion of department goals.

• Lead end‑to‑end planning, execution, monitoring, and completion of one or more clinical studies within vaccine programs.
• Ensure adherence to timelines, budgets, and quality standards.
• Develop and oversee study documents and plans to ensure GCP and regulatory compliance.
• Provide expert input into study protocols, informed consents, clinical study reports, and other clinical documents.
• Oversee the creation, maintenance, and completeness of the Trial Master File (TMF) for inspection readiness.
• Review trial data to guarantee completeness and accuracy in collaboration with relevant functions.
• Coordinate quality and compliance activities with cross‑functional teams and vendors, proactively identifying and mitigating risks/issues.
• Develop, manage, and refine budgets, forecasts, and reporting for assigned programs.
• Serve as functional representative on cross‑functional teams, facilitating communication among departments.
• Lead or contribute to cross‑functional initiatives and process improvement efforts.
• Provide oversight in the selection, training, and management of study personnel, CROs, and other vendors.
• Manage direct line reports, providing coaching, mentorship, and performance feedback.
• Collaborate closely with Clinical Operations leadership for strategic decisions and alignment with departmental goals.

• Extensive knowledge of clinical development principles and pharmaceutical industry standards, including GCP and ICH guidelines.
• Understanding of the lifecycle of a clinical trial from protocol development to study close‑out.
• Experience leading global studies and working with diverse international teams.
• Advanced written and oral communication skills in English, with the ability to convey medical and scientific information to vendors, consultants, and peers.
• Strong problem‑solving and decision‑making abilities in ambiguous situations.
• Interpersonal skills to work effectively with team members across cultures and personalities.
• Experience interfacing and managing multiple vendors and contractors.

Education and Experience:

- Bachelor’s or advanced degree in life sciences, pharmacy, or a related field.
- Minimum 15+ years of experience in the biopharmaceutical industry (10+ years with a Master’s) or 5+ years in vaccine clinical trial management.

Base salary range: $ – $. The total compensation package includes merit‑based salary increases, an incentive plan, eligibility for a 401(k) plan, medical, dental, vision, life and disability insurance, and paid time off at 11 holidays, flexible PTO, 80 hours of paid sick time, and additional time off during the last week of December.

Sumitomo Pharma America is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, domestic partnership or civil union status, sex, gender, sexual orientation, disability, veteran or military status, or any other characteristic protected by law.

Travel:
Primarily remote with periodic on‑site meetings; domestic and international travel required as needed.
Drug screening:
Subject to pre‑employment drug testing as required for certain roles.