Gilead Sciences, Inc.
Director, Clinical Pharmacology, Oncology
Gilead Sciences, Inc., Foster City, California, United States, 94420
Director, Clinical Pharmacology, Oncology
United States - New Jersey - Parsippany, United States - California - Foster City Clinical Development & Clinical Operations Regular
As a Director within the Clinical Pharmacology Group at Gilead, you will have significant responsibility and accountability for clinical pharmacology programs in Oncology. As a member of the Clinical Pharmacology team you will have unparalleled opportunity to be involved with every aspect of the product development process, from first-in human through approval, including post-marketing activities. In this role, you will have the advantage of providing input into a breadth of products within and across your area of responsibility. We seek to provide a fun and rewarding career and a continuous learning experience.
Responsibilities:
Leading clinical pharmacology studies of the highest complexity
Providing strategic leadership and demonstrating accountability for the clinical pharmacology programs supporting Phase 1-4 clinical development for development compounds in your therapeutic area
Developing and implementing new clinical pharmacology tools and technologies to drive smarter drug development for programs
Representing the department and providing subject matter expertise on cross-functional project teams
Developing and maintaining collaborative working relationship with colleagues within and outside the department
Supervising, developing and mentoring junior level scientists, via matrix structure in clinical pharmacology teams
Authoring/reviewing/approving clinical protocols, analysis plans, study reports and regulatory submissions
Developing high quality clinical pharmacology plans and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs and pediatric plans
Evaluating departmental and broader organizational SOPs as fit for purpose, in compliance with current scientific standards and regulatory requirements
Ensuring adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
Understanding the impact of decisions and actions on the business and consulting with colleagues and management as applicable
Participating in and collaborating with individuals from across the business in special projects
Developing and presenting training within and outside the department
Requirements: We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role
Specific Education, Experience & Skills
At least 8 years’ experience and a, PhD, PharmD or MD degree with emphasis in clinical pharmacology, pharmacokinetics or a related scientific discipline
In-depth knowledge of pharmacokinetic and other analysis software programs (e.g. WinNonlin, GraphPad, etc.
Solid understanding of modeling and simulation principles and approaches to include MnS tools in drug development decision making
Ability to work cross functional groups such as Pharmacometrics, Bioanalysis and Biomarkers etc
Thorough knowledge of current and emerging scientific standards regulatory requirements for assigned territories
Excellent written and oral communication skills and ability to convey complex technical information clearly
Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams and executives
Ability to critically analyze problems and provide creative solutions
Confidence and discipline to work autonomously
Genuine curiosity and drive to ask questions – looking for the ‘why’ of every project
Desire to strive for continuous improvement
When needed, ability to travel
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As a Director within the Clinical Pharmacology Group at Gilead, you will have significant responsibility and accountability for clinical pharmacology programs in Oncology. As a member of the Clinical Pharmacology team you will have unparalleled opportunity to be involved with every aspect of the product development process, from first-in human through approval, including post-marketing activities. In this role, you will have the advantage of providing input into a breadth of products within and across your area of responsibility. We seek to provide a fun and rewarding career and a continuous learning experience.
Responsibilities:
Leading clinical pharmacology studies of the highest complexity
Providing strategic leadership and demonstrating accountability for the clinical pharmacology programs supporting Phase 1-4 clinical development for development compounds in your therapeutic area
Developing and implementing new clinical pharmacology tools and technologies to drive smarter drug development for programs
Representing the department and providing subject matter expertise on cross-functional project teams
Developing and maintaining collaborative working relationship with colleagues within and outside the department
Supervising, developing and mentoring junior level scientists, via matrix structure in clinical pharmacology teams
Authoring/reviewing/approving clinical protocols, analysis plans, study reports and regulatory submissions
Developing high quality clinical pharmacology plans and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs and pediatric plans
Evaluating departmental and broader organizational SOPs as fit for purpose, in compliance with current scientific standards and regulatory requirements
Ensuring adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
Understanding the impact of decisions and actions on the business and consulting with colleagues and management as applicable
Participating in and collaborating with individuals from across the business in special projects
Developing and presenting training within and outside the department
Requirements: We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role
Specific Education, Experience & Skills
At least 8 years’ experience and a, PhD, PharmD or MD degree with emphasis in clinical pharmacology, pharmacokinetics or a related scientific discipline
In-depth knowledge of pharmacokinetic and other analysis software programs (e.g. WinNonlin, GraphPad, etc.
Solid understanding of modeling and simulation principles and approaches to include MnS tools in drug development decision making
Ability to work cross functional groups such as Pharmacometrics, Bioanalysis and Biomarkers etc
Thorough knowledge of current and emerging scientific standards regulatory requirements for assigned territories
Excellent written and oral communication skills and ability to convey complex technical information clearly
Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams and executives
Ability to critically analyze problems and provide creative solutions
Confidence and discipline to work autonomously
Genuine curiosity and drive to ask questions – looking for the ‘why’ of every project
Desire to strive for continuous improvement
When needed, ability to travel
#J-18808-Ljbffr