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 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

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

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

The base salary range for this role is

$236,400.00 - $295,500.00

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.

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.