Senior Clinical Pharmacology Expert
1 day ago
Job Summary:
We are seeking a highly skilled Senior Clinical Pharmacologist to lead clinical pharmacology studies in the Virology therapeutic area. As a key member of our team, you will be responsible for designing and conducting clinical pharmacology studies, analyzing and interpreting data, and providing clinical pharmacology input into regulatory filings.
Key Responsibilities:
- Design and conduct clinical pharmacology studies, including protocol development and study execution
- Analyze and interpret data from clinical pharmacology studies, including PK-PD and related analyses
- Provide clinical pharmacology input into regulatory filings, including clinical pharmacology plans and development plans
- Collaborate with cross-functional teams, including research and development, regulatory, and clinical operations
- Lead and manage small cross-functional project teams, including study concept and protocol design
- Author clinical pharmacology development plans and modeling and simulation plans
- Conduct PK-PD, Pop PK-PD, and related analyses, and contribute to regulatory filings, clinical publications, and presentations
Requirements:
- PharmD or PhD in pharmaceutical sciences, pharmacology, or related discipline with 5+ years' relevant research or clinical experience
- Relevant experience in Virology therapeutic area
- Significant experience leading small cross-functional project teams in drug research or development
- Significant experience leading study concept and protocol design, authoring clinical pharmacology development plans, and modeling and simulation plans
- Proven effectiveness managing clinical project deliverables through matrix management
- Experience supporting clinical publications and presentations is strongly preferred
Knowledge and Skills:
- Demonstrated ability to be a fast learner
- Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed
- Recognized for sustained scientific excellence
- Thorough knowledge of FDA and EMA regulations, ICH guidelines, and GCP governing the conduct of clinical studies
- Has significant knowledge of pharmaceutical regulatory requirements related to clinical pharmacology
- Has advanced knowledge of R&D and major disease areas, as evidenced by effectiveness supporting clinical projects
- Demonstrable ability to effectively apply business acumen to strategic scientific projects
- Significant knowledge of PK-PD, Pop PK-PD analyses and techniques and the physiological/pharmacological aspects of drugs
- Able to serve as a clinical pharmacology specialist in authoring clinical pharmacology protocols, development plans, and modeling and simulation plans, conducting of PK-PD, Pop PK-PD, and related analyses, and literature and regulatory guidelines
- Strong communication and organizational skills
- When needed, ability to travel
-
Senior Associate Scientist, In Vivo Pharmacology
4 weeks ago
Foster City, California, United States Gilead Sciences, Inc. Full timeSenior Associate Scientist, In Vivo PharmacologyUnited States - California - Foster CityGilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living...
-
Senior Clinical Pharmacologist II
1 month ago
Foster City, California, United States Gilead Sciences, Inc. Full timeSenior Clinical Pharmacologist IIUnited States - California - Foster CityGilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with...
-
Lead Clinical Pharmacologist in Virology
2 weeks ago
Foster City, California, United States Gilead Sciences, Inc. Full timePosition Overview As a Senior Clinical Pharmacologist specializing in Virology, you will play a pivotal role in steering clinical pharmacology investigations with a focus on HIV therapeutics. Your expertise will guide projects from initial human trials through to regulatory approval and post-marketing evaluations, including pediatric considerations....
-
Senior Clinical Study Management Specialist
3 weeks ago
Foster City, California, United States Hydrogen Group Full timePosition Overview:A prominent Biopharma organization is in search of a dedicated individual to take on the role of Senior Clinical Study Management Specialist. This position is structured as a contract opportunity with a competitive compensation range based on experience.The successful candidate will collaborate with Clinical Operations team members...
-
Senior Clinical Study Management Specialist
2 weeks ago
Foster City, California, United States Hydrogen Group Full timePosition Overview:Hydrogen Group is currently in search of a dedicated professional to take on the role of Senior Clinical Study Management Specialist. This position is structured as a contract role, offering a competitive hourly rate based on experience.The successful candidate will play a pivotal role in supporting the Clinical Operations team throughout...
-
Lead Clinical Pharmacologist in Virology
2 weeks ago
Foster City, California, United States Gilead Sciences, Inc. Full timePosition Overview As a Senior Clinical Pharmacologist specializing in Virology, you will take on a pivotal role in steering clinical pharmacology investigations that are increasingly intricate, particularly in the realm of HIV treatment. Your responsibilities will encompass the entire spectrum of clinical pharmacology program activities, from initial...
-
Lead Clinical Pharmacologist in Virology
2 weeks ago
Foster City, California, United States Gilead Sciences, Inc. Full timePosition Overview As a Senior Clinical Pharmacologist specializing in Virology, you will take on a pivotal role in leading complex clinical pharmacology studies focused on HIV therapeutics. Your expertise will guide projects from initial human trials through to approval and post-marketing phases, including pediatric considerations. Collaborating with...
-
Senior Research Associate
2 days ago
Foster City, California, United States R&D Partners Full timeAbout the RoleR&D Partners is seeking a highly skilled Senior Research Associate to join our team in the field of Drug Metabolism.Main Responsibilities:Develop and apply protein LCMS-based assays to support drug development.Analyze and interpret biologics bioanalytical data to inform research decisions.Collaborate with cross-functional teams to troubleshoot...
-
Senior Clinical Trial Management Specialist
3 weeks ago
Foster City, California, United States Integrated Resources, Inc Full timeJob OverviewPosition Title: Senior Clinical Trial Management SpecialistLocation: RemoteContract Duration: 06+ monthsCompensation: $60 - $64/hr. on W2Position Summary:As a Senior Clinical Trial Management Specialist, you will play a pivotal role in the execution of clinical trials across various phases, ensuring adherence to established protocols and...
-
Senior Research Associate II
2 weeks ago
Foster City, California, United States ATR International Full timeJob Description:We are seeking a highly skilled Senior Research Associate II to provide bioanalytical support to our biologics discovery project teams at ATR International. The successful candidate will work closely with cross-functional teams to optimize leads and select candidates for clinical evaluation.The primary responsibility of this Biologics...
-
Lead Clinical Pharmacologist
3 weeks ago
Foster City, California, United States Gilead Sciences Full timePosition Overview:As a pivotal member of our team, you will independently spearhead the clinical pharmacology strategy and oversee clinical pharmacology studies within the Oncology domain, particularly focusing on innovative combinations involving immune-oncology agents and antibody-drug conjugates. Your role will encompass the entire spectrum from...
-
Foster City, California, United States Gilead Sciences, Inc. Full timeSenior Research Associate I- In Vivo PharmacologyUnited States - California - Foster CityGilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients...
-
Senior Clinical Trial Management Specialist
2 weeks ago
Foster City, California, United States LeadStack Inc. Full timePosition Title: Senior Clinical Trial Management SpecialistDuration: 6 months with potential for extensionLocation: RemoteCompensation: $40-$55/hr on W2Department: Clinical Operations – Biomarker and Bioanalytical OperationsClinical Operations is tasked with the global execution of all Phase I - IV clinical trials across various therapeutic areas. This...
-
Senior Research Associate
2 days ago
Foster City, California, United States ACL Digital Full timeAbout the RoleWe are seeking a highly skilled Senior Research Associate - II to join our team at ACL Digital. As a key member of our research team, you will be responsible for leading the development and application of protein LCMS-based assays.Key Responsibilities:Develop and implement LCMS methods for quantitative peptide analysis.Collaborate with...
-
Senior Research Associate II
2 weeks ago
Foster City, California, United States ATR International Full timeJob SummaryWe are seeking a highly skilled Senior Research Associate II to provide bioanalytical support to our biologics discovery project teams at ATR International. The successful candidate will work closely with cross-functional teams to optimize leads and select candidates for clinical evaluation.Key ResponsibilitiesProvide bioanalytical support to DMPK...
-
Senior Research Associate II
2 days ago
Foster City, California, United States ATR International Full timeJob Summary:We are seeking a highly skilled Senior Research Associate II to provide bioanalytical support to our biologics discovery project teams at ATR International. The successful candidate will work closely with cross-functional teams to optimize leads and select candidates for clinical evaluation.Key Responsibilities:Provide bioanalytical support to...
-
Lead Clinical Trial Manager
2 weeks ago
Foster City, California, United States Vakulatech Full timePosition OverviewJob Title: Senior Clinical Trial Manager - Biomarker and Bioanalytical OperationsCompany: VakulatechRole Duration: 6 monthsCompensation: $45-$50/hr W2Visa Requirements: Open to all visa types except H1BOverview: The Clinical Operations team is pivotal in executing Phase I to IV clinical trials across various therapeutic areas. This role is...
-
Senior Research Associate
20 hours ago
Foster City, California, United States Infotree Global Solutions Full timeJob Title: Senior Research Associate (Drug Metabolism/Pharmacokinetics)Job Summary:Infotree Global Solutions is seeking a highly skilled Senior Research Associate to join our team in Foster City, CA. As a key member of our bioanalytical team, you will be responsible for providing critical support to our Drug Metabolism and Pharmacokinetics project...
-
Clinical Development Director
50 minutes ago
Foster City, California, United States Gilead Sciences, Inc. Full timeAbout the RoleThe Director, Clinical Development Hepatitis will provide clinical leadership and input on clinical studies, supporting the hepatitis programs. This role will lead or assist on multiple components of clinical trial programs in Hepatitis clinical development, including design, conduct, and evaluation of Phase 1-4 clinical trials.Key...
-
Lead Clinical Trial Operations Manager
2 weeks ago
Foster City, California, United States Vakulatech Full timePosition OverviewJob Title: Senior Clinical Trial Manager - Biomarker and Bioanalytical OperationsCompany: VakulatechJob Duration: 6 monthsCompensation: $45-$50/hr W2Visa Requirements: Acceptable for all visa types except H1BRole Summary:The Clinical Operations department is tasked with the global execution of all phases of clinical trials across various...