Associate Director, Clinical Pharmacologist

Job Description
The position is a part of the clinical pharmacology team located at Gilead's corporate office in Foster City, CA - San Francisco Bay Area, and supports programs in oncology, inflammation, and respiratory therapeutic areas.

• Responsible for timely delivery of clinical pharmacology, PK, PK/PD, and/or population PK initiatives, based on efficient and innovative study design, analysis, interpretation, and reporting for small and large molecules.
• Represent and provide clinical pharmacology expertise and leadership at cross-functional development project team, clinical subteam, study team, partnering with clinical research, biometrics, project management, clinical operations, drug metabolism, biology/biomarkers, toxicology etc.
• Provide clinical pharmacology expertise in the preparation of regulatory submissions (i.e., IB, IND, NDA, MAA, BLA). Experience with international regulatory standards, practices and agencies desired.
• Work closely with bioanalytical team within the clinical pharmacology group to ensure high quality and timely deliverables for small and large molecule PK.
• Mentor and manage scientists within the clinical pharmacology group.


Essential Duties and Job Functions: • Strong understanding of drug development process to provide strategic clinical pharmacology leadership and support for clinical development (Phase 1 to Phase 4) for investigational agents and/or marketed drugs.
• Develop dose-finding strategies using innovative methods to integrate pharmacokinetics, pharmacodynamics, patient characteristics and disease states, during early clinical drug development to ensure optimal dose and dosage regimen selection to enable pivotal studies/regulatory filings.
• Extensive knowledge of clinical pharmacology considerations in drug development, including evaluation of dose-response, drug-drug interactions, safety assessments such as thorough QT, special populations including organ impairment, pediatrics, bioavailability/bioequivalence.
• Develop an efficient yet thorough clinical pharmacology plan with appropriate timelines within the clinical development plan supporting overall regulatory strategy.
• Extensive knowledge of ADME and demonstrated expertise in principles of using non-compartmental and model-based PK and PK/PD, and relevant scientific disciplines, including drug metabolism, drug transport, formulation sciences, biopharmaceutics, pathophysiology and therapeutics.

• Work independently in a fast-paced setting to provide clinical pharmacology deliverables to enable project-level decision making, including effectively communicating and obtaining alignment with senior management.
• Analyze, interpret, and write highly complex reports for clinical and regulatory submissions.
• Manage timelines and budgets to ensure prompt and accurate execution of clinical studies.
• Oversee scientific work/projects involving external contractors and/or vendors.
• Demonstrate excellent written and verbal data presentation skills enabling contribution to internal/external multi-disciplinary teams, conference presentations and publications.
• Must have established computer skills with detailed knowledge of PK programs and analysis software (e.g. WinNonlin, Nonmem, ADAPT II, Kinetica, WinNonmix, SAS, etc.), along with experience with scientific graphing and analysis software (Sigma plot, GraphPad, etc.). Population PK and extensive PK/PD modeling experience is highly desirable.
• Understand and apply appropriate FDA, EMA and ICH guidelines in the design of clinical pharmacology and development plans and studies. Experience in face-to-face regulatory interactions desirable


Knowledge, Experience and Skills: • Typically requires a MD, PhD, or PharmD degree in pharmacokinetics, pharmaceutical sciences, or in a related scientific discipline and 8+ years of clinical pharmacology experience in industry setting.

Company

Gilead Sciences

Job Code

State or Province

California

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