<p>Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.</p> <p>We are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in clinical pharmacology, and a working knowledge of drug metabolism and bioanalytic chemistry.</p> <p>Job Duties and Responsibilities</p> <ul> <li>Represent the clinical pharmacology and drug metabolism department, provide PK, PK/PD, clinical pharmacology and drug-metabolism expertise to project teams. </li><li>Design clinical pharmacology components of clinical studies. </li><li>Create clinical pharmacology drug-development plans as required. </li><li>Analyze and interpret clinical pharmacology data. </li><li>Interact with pre-clinical scientists in analyzing and interpreting drug metabolism and pharmacologic data. </li><li>Analyze and interpret drug metabolism and ADME data. </li><li>Direct activities of contract research laboratories (CROs), including metabolism and bioanalytic activities and assuring GxP compliance. </li><li>Author reports/chapters of reports including those intended for regulatory submission. For example, clinical study reports (CSRs), investigator brochures (IB), new drug application (NDA) common technical document (CTD) non-clinical drug metabolism, bioanalytic, and clinical pharmacology chapters, and alike. </li><li>Support clinical protocols and protocol execution, including lab manual authoring based on information received from bioanalytic laboratories, pharmacokinetic (PK) sample logistics, and site initiation activities (in synchrony with Clinical Operations). </li><li>Collaborate with other line functions and all members of the Clinical Pharmacology and Drug Metabolism department. </li><li>Exhibit versatility in accordance with the ebbs and flow of shifting needs in accordance with the various stages of the drug development efforts. </li><li>Other duties as needed. </li></ul> <p>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.</p> <p>Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.</p> <p>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.</p> <p>Mental/Physical Requirements: Fast paced environment handling multiple demands. 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.</p> <p>Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer</p> <p>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.</p>