Senior Director, Clinical Trials Management

Sumitomo Pharma•Marlborough, MA

1d•Remote

About The Position

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. 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. The Senior Director, Clinical Trials Management is responsible for operational leadership and oversight for vaccine clinical programs including operational strategy, clinical trial conduct, project planning, budget management, timelines, resource management, site management, monitoring, study management, vendor management, and project operational support. Drives all aspects of study execution in collaboration with cross-functional teams and vendors. 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. Represents clinical trial management on program steering committees and other committees as required.

Requirements

Extensive knowledge of clinical development principles, theories and concepts and knowledge of pharmaceutical industry practices and standards, including GCP and ICH-Guidelines
Familiarity with the lifecycle of a clinical trial: from protocol development and feasibility through study close-out and reporting
A thorough understanding of the drug development process.
Experience as a clinical operations lead for global studies.
Current on industry standards and trends.
Familiarity and experience working with global team members and experience managing expats or those assigned to work abroad
Excellent written and oral communication skills to effectively communicate in English
Ability to communicate in medical and scientific terms with vendors, consultants, and peers in English
Ability to read, analyze and interpret professional journals, technical procedures, and/or government regulations in English.
Ability to write reports, business correspondence and procedure manuals in English.
Ability to effectively present information to and respond to questions from groups of managers, sites, etc.
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.
Ability to get along well with different personalities and to work well in teams.
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.
Minimum 15+ years (w/o Master’s) or 10+ years (with Master’s) of relevant experience in biotech or pharmaceutical industry

Nice To Haves

Preferred minimum 5 years direct experience in clinical trial management of vaccine programs.

Responsibilities

Responsible for directing the end-to-end planning, execution, monitoring, and successful completion of one or more clinical studies within the vaccine program(s), ensuring adherence to timelines, budgets, and quality standards
Develop and oversee the proliferation of study documents and plans to ensure adequate controls, aligning with GCP and regulatory requirements for study conduct.
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.
Review trial data to ensure completeness and accuracy of data and reporting in collaboration with other relevant functions.
In collaboration with Clinical Operations Study Lead (as applicable), cross-functional teams and vendors on quality and compliance activities, ensuring continuous improvement in study conduct, proactively identifying and mitigating risks/issues to the study to ensure successful study conduct and reporting of study data.
Develop, manage, and refine budgets, forecasts, and reporting, for the assigned program, collaborating with relevant stakeholders to ensure financial oversight and control
Serve as the functional representative on cross-functional teams related to the assigned program, facilitating effective communication and collaboration among various departments
Assume a proactive role in cross-functional initiatives, potentially leading or contributing as a subject matter expert, ensuring that clinical operations considerations are integrated effectively
Provide subject matter expertise on department initiatives, workstreams, and process improvement efforts, contributing to the continuous enhancement of clinical operations processes and procedure, as necessary
Contribute to the development and refinement of organizational policies, procedures, and resourcing strategies related to clinical operations activities.
Provide oversight in the selection, training, and management of study personnel, Contract Research Organizations (CROs), and other vendors, ensuring they meet project requirements and objectives of the assigned program
Manage direct line reports, providing guidance, mentorship, and performance feedback to ensure their professional growth and the successful execution of their responsibilities
Collaborate closely with the Clinical Operations leadership team, potentially serving as a member of the team to share insights, contribute to strategic decisions, and align program-level activities with departmental goals