Senior Director, Clinical Trials Management

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 womens 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. For more information on SMPA visit our website or follow us on LinkedIn.

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.

Job Duties and 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. 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. They may review trial data to ensure completeness and accuracy of data and reporting in collaboration with other relevant 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

Key Core Competencies

• 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.

Education and Experience

• Bachelors or advanced degree preferably in life sciences pharmacy or a related field.
• Minimum 15 years (w/o Masters) or 10 years (with Masters) of relevant experience in biotech or pharmaceutical industry
• Preferred minimum 5 years direct experience in clinical trial management of vaccine programs.

The base salary range for this role is

Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases short incentive plan participation eligibility for our 401(k) plan medical dental vision life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off 11 paid holidays plus additional time off for a shut-down period during the last week of December 80 hours of paid sick time upon hire and each year thereafter. Total compensation including base salary to be offered will depend on elements unique to each candidate including candidate experience skills education and other factors permitted 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.

Confidential Data: 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 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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Drug Screening Requirements
Applicants for sales/field manufacturing or other designated roles will be required to submit to a pre-employment drug test.

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 domestic partnership or civil union status; sex gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process please contact SMPA at . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.