Executive Director, Pharmacometrics Head
Executive Director, Pharmacometrics Head
United States - California - Foster City
Gilead 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 life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
As an Executive Director within the Clinical Pharmacology organization at Gilead, you will have ultimate responsibility and accountability for providing scientific and strategic input in implementing state of the art modeling and simulation strategies across therapeutic areas spanning virology, inflammation and oncology and have impact on drug development and decision making.
As a member of the Clinical Pharmacology department you will have unparalleled opportunity to apply quantitative approaches during the drug development process, from firstin human through approval, including postmarketing 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.
- Lead quantitative and innovative strategies well integrated within clinical pharmacology to impact model informed drug development (MIDD)
- Lead a team that can focus on new quantitative tools/technologies for potential platform analysis, disease modeling, new PK/PD modeling approaches, driving MIDD approaches across modalities
- Provide strategic leadership and technical oversight for pharmacometrics across multiple modalities and therapeutic areas supporting Phase 14 clinical development
- Develop and implementing new pharmacometrics and quantitative pharmacology approaches to drive smarter drug development for programs
- Guide dose regimen/optimization strategies in partnership with other therapeutic area leads and clinical pharmacology leads to enable data-driven decisions
- Evaluate and applying PBPK, RWD, AI/ML and other quantitative tools as appropriate for clinical pharmacology decision making
- Represent the department and providing subject matter expertise on crossfunctional project teams
- Develop and maintaining collaborative working relationship with colleagues within and outside the department
- Supervise, developing and mentoring junior level scientists, both direct reports and via matrix structure in clinical pharmacology teams
- Author/review/approve clinical protocols, modeling and simulation analysis plans, outputs, interpretation and presentation of key findings to regulators and to stakeholders as needed.
- Provide technical input for pharmacometrics reports and regulatory submissions
- Develop high quality modeling and simulation strategy and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs and pediatric plans
- Initiate, maintain and establishrelationships and agreements with contract vendors and pharmacometrics experts and consultants
- Evaluate departmental and broader organizational SOPs as fit for purpose, in compliance with current scientific standards and regulatory requirements
- Ensure adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
- Understand the impact of decisions and actions on the business and consulting with colleagues and management as applicable
- Participate in and collaborating with individuals from across the business in special projects
- Develop and present training within and outside the department
- 12+ years of experience and a PhD, PharmD or MD degree with emphasis in quantitative pharmacology, pharmacokinetics or a related scientific discipline
- Experience in developing and implementing clinical pharmacology and modeling/simulation strategies for novel modalities (example: mAbs, antibody drug conjugates, bispecifics, cell therapy, etc) and deliver lifesaving medicines
- Proven track record of extensive experience in population modeling and simulations
- Expertise with standard modelling and simulation software (NONMEM, SPlus/R, etc) is required. Knowledge of other software e.g. WinNonlin
- Thorough knowledge of current and emerging scientific standards regulatory requirements for assigned territories
- Demonstrated effective written and verbal l communication skills and ability to convey complex technical information clearly
- Confidence and ability to present to and influence senior leaders
- 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
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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact email@example.com for assistance.
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