Clinical Trials Management Director

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.

Essential Functions Required for Job

• 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 (general & technical):

• Implement clinical development principles and industry standards including GCP and ICH guidelines.

• Understands drug development and the end-to-end clinical trial lifecycle (protocol/feasibility through close-out and reporting).
• Experience as a clinical operations lead.
• Interprets applicable regulations and literature and stays current on evolving GCP/ICH expectations and inspection readiness.
• Communicates effectively with internal stakeholders sites vendors and consultants including translating scientific/medical concepts.
• Produces clear documentation (e.g. reports and procedures) and presents information effectively to groups.
• Solves problems and makes decisions in situations with limited standardization and multiple variables.
• Strong cross-functional collaboration across diverse global teams and leads through influence/coaching in a management role.
• Manages multiple vendors/contractors and coordinates partners to deliver study objectives.
• Prioritizes and delivers across competing timelines; manages time and multiple tasks.
• Demonstrates organizational awareness and connects interdependencies to maintain the broader program perspective.

Education & Experience Requirements:

• Bachelors or advanced degree preferably in life sciences pharmacy or a related field.
• Minimum 1015 years (without Masters) or 812 years (with Masters) of relevant experience in biotech/pharmaceutical or CRO setting with experience supporting Phases 14 clinical studies.

Preferred Qualifications:

• Experience managing global patient population studies.
• Therapeutic experience working with stem cells and regenerative medicine.
• Strong phase1/2 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 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 the ability to use a personal computer for extended periods of time.

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.