Clinical Pharmacology Lead

New

Skills

Collaboration Data Analysis Project Management

Sumitomo Pharma America, Inc. is committed to advancing global health by delivering innovative treatments across critical therapeutic areas, including psychiatry, neurology, oncology, urology, women's health, rare diseases, and cell & gene therapy. As a Senior Manager or Associate Director in Clinical Pharmacology and Drug Metabolism, you will play a pivotal role in designing, implementing, and analyzing clinical pharmacology strategies within a diverse and dynamic pipeline. This position collaborates cross-functionally to drive patient-first, technology-driven drug development.

Key Responsibilities

Represent the Clinical Pharmacology and Drug Metabolism department in internal and external forums.
Design clinical pharmacology components for clinical studies and overall drug development plans.
Analyze, interpret, and report clinical pharmacology data to inform project direction.
Collaborate closely with cross-functional teams to support protocol development and execution.
Engage with regulatory authorities, ensuring compliance and effective communication.

Required Skills & Qualifications

Bachelor's degree in a relevant field (PhD in pharmacokinetics, clinical pharmacology, biology, biochemistry, or related discipline preferred).
6-8 years of experience in biotech or pharmaceutical drug development (or 4-6 years with a Master's degree).
Demonstrated experience interacting with regulatory agencies (FDA, EMA/CPMP, PMDA, etc.).
Strong skills in clinical pharmacology study design and data analysis.
Oncology drug development experience is a strong plus.
Excellent cross-functional collaboration and communication abilities.

Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: 12 Months

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