Sumitomo Pharma Co., Ltd. is a dynamic global pharmaceutical company based in Japan, dedicated to meeting patient needs in various therapeutic areas, including oncology, urology, women’s health, rare diseases, cell and gene therapies, and CNS disorders. We have a robust portfolio of marketed products alongside an innovative pipeline of investigational assets. Our mission is to expedite the discovery, research, and development of novel therapies to improve patient outcomes.

Job Overview

As the Senior Medical Director leading Pharmacovigilance and Risk Management (PVRM), you will play a critical role in overseeing the medical safety aspects of our clinical trials. Your responsibilities will include addressing safety queries related to clinical documents such as protocol, Informed Consent Forms, and Safety Management Plans. You will also conduct medical reviews and assessments of individual case safety reports, ensuring high-quality narratives, adverse event coding, and evaluating causality.

In this vital role, you will provide expert guidance on aggregate safety reports and support signal management throughout the product lifecycle. You will report directly to the VP of PVRM and the Global Pharmacovigilance Head, ensuring alignment with our safety governance policies and maintaining communication with senior leadership regarding safety issues.

Key Responsibilities
• Lead safety strategy in NDA/BLA/MAA submissions.
• Oversee ongoing safety monitoring for both investigational and marketed products.
• Represent PVRM in product-specific and clinical study team meetings.
• Prepare and present safety analyses to project teams and senior management.
• Evaluate and contribute authoring of safety sections for study-related documents.
• Assist in preparing and updating Company Core Data Sheets and local labels.
• Conduct medical reviews of aggregate reports and respond to regulatory safety inquiries.
• Support safety evaluations and signal detection activities.
• Collaborate in activities such as literature evaluation and investigator site training.
• Maintain strong relationships with cross-functional teams in Clinical Development and Operations.
• Stay informed on global regulatory authority requirements.
• Ensure compliance with regulations and promote a culture of “Patient first”.
• Perform timely review and assessment of individual case safety reports.

Key Core Competencies
• Deep understanding of the pharmaceutical industry, particularly in clinical research and regulatory requirements.
• Strong knowledge of FDA and ICH safety reporting regulations and guidelines.
• Excellent strategic, critical thinking, and communication skills.
• Ability to work well within teams and effectively lead initiatives.
• Advanced problem-solving and analytical capabilities.
• Willingness to travel domestically and internationally as needed.
• Proven coaching and mentoring skills to develop team members.
• High level of organizational awareness to grasp the bigger picture.

Education and Experience
• Medical Degree (MD) with a minimum of 12 years of relevant experience in the pharmaceutical or biotech industry.
• Experience in Oncology and Neurology is highly preferred.
• Familiarity with NDA/BLA/MAA submissions.
• Prior experience managing teams is essential.

This role offers a base salary range of $288,200.00 to $360,200.00, along with a comprehensive rewards package, including merit-based increases, incentive plan participation, and various insurance benefits. We also provide a robust time-off policy and additional paid sick time. Total compensation will be determined based on individual candidate qualifications and experience.

Disclaimer: This description indicates the general nature and level of work performed, and is not an exhaustive list of all responsibilities. All personnel may be asked to perform duties outside their normal responsibilities as necessary.

Compliance: Adherence to all regulatory, legal, and operational rules is expected, and we uphold the highest ethical standards in all activities.

Mental/Physical Requirements: The role functions in a fast-paced environment requiring the ability to manage multiple demands, exercise sound judgment, and utilize a personal computer for extended periods.

Travel Requirements: This position is primarily remote with occasional on-site meetings as required.

Sumitomo Pharma America is an Equal Employment Opportunity employer. Qualified applicants will be considered for employment without regard to various protected characteristics. We strive to make our application process accessible to everyone. If you need assistance or have questions about the application process, please contact us for accommodations.