Clinical Trials Management Director

 therapies to patients sooner. For more information, visit https://www.us.sumitomo-pharma.com or follow us on LinkedIn.
Responsibilities
• Direct the end-to-end planning, execution, monitoring, and successful completion of one or more clinical studies within a program(s), ensuring adherence to timelines, budgets, and quality standards.
• Oversee the development and control of key study documents and plans (e.g., protocols, informed consents, clinical study reports), ensuring alignment with GCP and regulatory requirements.
• Oversee Trial Master File (TMF) set-up, maintenance, and completeness to ensure inspection readiness; collaborate with relevant functions to support data completeness and accurate reporting.
• Proactively identify, manage, and mitigate study/program risks and issues; lead quality and compliance activities with cross-functional teams and vendors to drive continuous improvement.
• Develop, manage, and refine budgets, forecasts, and financial reporting for the assigned program(s), ensuring appropriate oversight and control.
• Serve as the clinical operations' functional representative on cross-functional program teams; facilitate effective communication and collaboration across departments and with external partners.
• Provide subject matter expertise for departmental initiatives and process improvement efforts; contribute to the development and refinement of clinical operations policies, procedures, and resourcing strategies.
• Provide oversight in the selection, onboarding, training, and performance management of study personnel, CROs, and other vendors to ensure delivery against contracts, expectations, and program objectives.
• Manage direct reports (as applicable) through coaching, mentorship, and performance feedback; collaborate with Clinical Operations leadership to align program-level activities with departmental goals and strategy.
Knowledge, Skills and Abilities
• Implement clinical development principles and industry standards, including GCP and ICH guidelines.
• Understand drug development and the end-to-end clinical trial lifecycle (protocol/feasibility through close-out and reporting).
• Experience as a clinical operations lead.
• Interpret applicable regulations and literature and stay current on evolving GCP/ICH expectations and inspection readiness.
• Communicate effectively with internal stakeholders, sites, vendors, and consultants, including translating scientific/medical concepts.
• Produce clear documentation (e.g., reports and procedures) and present information effectively to groups.
• Solve problems and make decisions in situations with limited standardization and multiple variables.
• Demonstrate strong cross-functional collaboration across diverse, global teams and lead through influence/coaching in a management role.
• Manage multiple vendors/contractors and coordinate partners to deliver study objectives.
• Prioritize and deliver across competing timelines; manage time and multiple tasks.
• Demonstrate organizational awareness and connect interdependencies to maintain the broader program perspective.
Education & Experience Requirements
• Bachelor’s or advanced degree, preferably in life sciences, pharmacy, or a related field.
• Minimum 10–15 years (without Master’s) or 8–12 years (with Master’s) of relevant experience in biotech/pharmaceutical or CRO setting, with experience supporting Phases 1–4 clinical studies.
Preferred Qualifications
• Experience managing global patient population studies.
• Therapeutic experience working with stem cells and regenerative medicine.
• Strong phase 1/2 experience.
Travel Requirements

Primarily remote role with periodic on-site meetings. Must be able to travel domestically and internationally as needed.
Mental/Physical Requirements

Fast‑paced environment handling multiple demands. Must exercise appropriate judgment, demonstrate initiative and independence, and possess excellent written and oral communication skills. Ability to use a personal computer for extended periods of time is required.
Compensation

The base salary range for this role is $195,500.00 – $244,400.00. Base salary is part of our total rewards package, which also includes merit‑based salary increases, short‑term incentive plan participation, 401(k) plan eligibility, medical, dental, vision, life and disability insurance, and paid time off. Total compensation will depend on individual experience, skills, education and other factors allowed by law.
Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Confidentiality

All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law.
Compliance

Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures, ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the highest industry practices and ethical standards.
Equal Employment Opportunity

Sumitomo Pharma America (SMPA) 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, sexual orientation, gender, disability, veteran or military status, domestic violence victim status, genetic information, or any other characteristic protected by law.
Accessibility

Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. For assistance with accessibility, contact [email protected]. This contact is for accommodation requests only and may not be used to inquire about the status of applications.
Artificial Intelligence in Application

SMPA may use Artificial Intelligence (AI) as part of the job application process, including to assist in evaluating applicants. By submitting information, you acknowledge that the company may use AI tools as part of the evaluation.
Mission & Vision

Mission: To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide.

Vision: For longer and healthier lives, we unlock the future with cutting‑edge technology and ideas.

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