Sumitomo Pharma Co., Ltd

Senior Director, Clinical Trials Management

US-Remote · Director

Sponsorship not specified$236k-$296kDetected 9 days ago

GCPAccessibilityProcess ImprovementVendor ManagementRecruitingClinical TrialsResearchLeadershipCommunicationCollaborationMentoring

About the role

With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner.
For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.
Has the ability to offer strategic direction for clinical trials activities primarily in the US, Japan and Europe and other world areas as assigned, to ensure timely completion of department goals and objectives with minimum supervision.

Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
Develop and oversee the proliferation of study documents and plans to ensure adequate controls, aligning with GCP and regulatory requirements for study conduct.
They will provide expert input into study protocols, informed consents, clinical study reports, and other clinical documents, as appropriate for assigned studies.
Develop and oversee the set-up, maintenance, and completeness of the Trial Master File (TMF) for inspection readiness.
Develop, manage, and refine budgets, forecasts, and reporting, for the assigned program, collaborating with relevant stakeholders to ensure financial oversight and control
Manage direct line reports, providing guidance, mentorship, and performance feedback to ensure their professional growth and the successful execution of their responsibilities
Experience as a clinical operations lead for global studies.

Must be able to exercise appropriate judgment as necessary.
Excellent written and oral communication skills required.
Requires ability to use a personal computer for extended periods of time.
Must be able to travel domestically and internationally as needed.
Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test.
Must have demonstrated ability to work independently and in a team, and provide leadership in a management role.
Must have experience interfacing and managing multiple vendors/ contractors Ability to manage time, multi-task and prioritize to complete deliverables on schedule.
Bachelor's or advanced degree, preferably in life sciences, pharmacy, or a related field.

Ability to communicate in medical and scientific terms with vendors, consultants, and peers in English
Ability to solve problems and deal with a variety of concrete variables in situations where only limited standardization exists Must be tactful, mature, flexible, and have well-developed interpersonal skills.

Familiarity and experience working with global team members and experience managing expats or those assigned to work abroad

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

This listing is sourced directly from Sumitomo Pharma Co., Ltd's careers page and normalized into a canonical job model.