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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 (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=3440496098&u=https%3A%2F%2Fwww.us.sumitomo-pharma.com%2F&a=https%3A%2F%2Fwww.us.sumitomo-pharma.com+) or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .

Job Overview

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. This position will report to Senior Director of Clinical Pharmacology and Drug Metabolism. S/he will work across organization and functions and collaborate closely with program management, clinical development, PV, Biostat/Data Management, CMC, Biomarker/Translational Research, preclinical DMPK, etc to formulate clinical pharmacology development strategy and detailed plan to support overall clinical development program. S/he will be responsible for developing clinical pharmacology and drug metabolism strategies and implementation of the strategies and associated plans.

Job Duties and Responsibilities

+ Represent the clinical pharmacology and drug metabolism department, provide PK, PK/PD, clinical pharmacology and drug-metabolism expertise to project teams.

+ Design clinical pharmacology components of clinical studies.

+ Create clinical pharmacology drug-development plans as required.

+ Analyze and interpret clinical pharmacology data.

+ Interact with pre-clinical scientists in analyzing and interpreting drug metabolism and pharmacologic data.

+ Analyze and interpret drug metabolism and ADME data.

+ Direct activities of contract research laboratories (CROs), including metabolism and bioanalytic activities and assuring GxP compliance.

+ 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.

+ 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).

+ Collaborate with other line functions and all members of the Clinical Pharmacology and Drug Metabolism department.

+ Exhibit versatility in accordance with the ebbs and flow of shifting needs in accordance with the various stages of the drug development efforts.

+ Other duties as needed.

Key Core Competencies

+ Demonstrated expertise in clinical pharmacology, clinical pharmacology program plan, study design, methods, data interpretation, implications, and reporting.

+ Knowledgeable in pre-clinical assessment methods and resultant data interpretation (ex: microsomes, hepatocytes, CACO2 systems).

+ Ability to work in a cross-functional environment.

+ Skilled in the use of pharmacokinetics software, a modeling platform, and a programing language enabling data manipulation, statistical analyses, and graphics is desirable. Examples include; Phoenix WinNonlin, Simcyp, GastroPlus, PK-Sim, PhysioDesigner, JMP, R (or S-plus), SAS, Stella, Berkeley Madonna, Prism GraphPad, Excel, NONMEM.

+ Demonstrated knowledgeability of bioanalytic chemistry.

+ Demonstrate coaching skill to develop team.

+ Excellent verbal and written communication skills in English.

Education and Experience

+ Bachelor’s degree in a related field required.

+ PhD in pharmacokinetics, clinical pharmacology, biology, biochemistry, or a related discipline with 2-4 years’ experience in drug development preferred.

+ Required: 6 – 8 years (w/o Master’s) or 4 – 6 years (with Master’s) of relevant experience in biotech or pharmaceutical drug development.

+ Experience in interaction with regulatory agencies such as the FDA, EMA/CPMP, PMDA, or others.

+ Experience in oncology drug development is a strong plus but not required.

The base salary range for this role is $134,000 to $168,000. 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 unlimited 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.

**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. 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.

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 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, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, 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 (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=3440496098&u=https%3A%2F%2Fwww.us.sumitomo-pharma.com%2F&a=https%3A%2F%2Fwww.us.sumitomo-pharma.com+) or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .

At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company’s cultural pillars.

Our** **Mission

_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_

Our** **Vision

_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_