Senior Director – Clinical Pharmacology

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $235.5k - $329.5k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Vir Biotechnology, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2016

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Vir Biotechnology, Inc. is a company focused on leveraging the potential of the immune system to address critical unmet medical needs and improve patient outcomes. It specializes in the discovery, engineering, and development of antibody-based medicines for viral health challenges such as COVID-19 and Ebola. Vir Biotechnology employs innovative platforms like the next-generation antibody and the PRO-XTEN™ protease-releasable masking technologies. With a therapeutic concentration on infectious diseases like hepatitis B and delta, as well as strategic programs in oncology, Vir is committed to advancing medical science and delivering transformative medicines efficiently. The company is supported by an experienced leadership team proficient in progressing product candidates through various stages of research to commercialization.

📋 Description

• Lead the technical and operational aspects of the Clinical Pharmacology department across preclinical and clinical development • Oversee clinical pharmacology and translational PK/PD operations and deliverables across infectious disease and oncology programs • Serve as the clinical pharmacology and translational PK/PD technical expert on cross-functional project teams • Develop clinical pharmacology strategies supporting development and regulatory decisions from pre-IND through market authorization • Select and execute PK/PD, PopPK, and exposure-response modeling and simulation approaches for dose selection and optimization • Author and provide technical input for regulatory documents, submissions, and responses • Collaborate with clinical research, clinical operations, biomarkers, bioanalytical, biometrics, CMC, research, and regulatory teams • Establish and manage external vendor and collaborating-partner relationships • Generate and manage departmental budgets and optimize resource allocation • Manage, hire, mentor, and develop the Clinical Pharmacology and Translational PK/PD team • Report to the VP of Translational Development

🎯 Requirements

• PhD, PharmD, or MD with relevant training in clinical pharmacology, pharmacokinetics, pharmaceutics, or related field • 13+ years industry experience in Clinical Pharmacology, DMPK and/or related fields • Mastery of nonclinical and clinical pharmacokinetic concepts and methodologies • Deep understanding of multidisciplinary drug development requirements • Expertise in PK/PD, PopPK and exposure-response modeling • Extensive experience leading translational and clinical pharmacology work from candidate selection through market authorization • Strong understanding of regulatory requirements and experience contributing to regulatory submissions and engagements • Working knowledge of bioanalytical techniques supporting clinical development of small molecules and biologics • Experience with biologics, including monoclonal antibodies and bispecifics, required • Experience in oncology indications strongly preferred • Proficiency using standard PK analysis and graphing programs • Proven ability to manage and develop teams • Must currently be authorized to work for any employer in the U.S.; visa sponsorship is unavailable

🏖️ Benefits

• Compensation, bonus and equity • Health and welfare benefit plans • Non-accrual paid time off • Company shutdown for holidays • Commuter benefits • 401K match • Lunch each day in the office