Director, Clinical Pharmacology, Oncology

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.

• 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

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

• At least 8 years’ experience and a, PhD, Pharm
  
  D 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. Win Nonlin, Graph Pad, 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