Senior Director, Clinical Pharmacology - Oncology
United States - New Jersey - Morris PlainsUnited 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 a Senior Director within the Clinical Pharmacology Group at Gilead, you will have ultimate responsibility and accountability for clinical pharmacology programs with for the Oncology therapeutic area.
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.Key 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
- Function as the sole point of contact for all Clinical Pharmacology activities on projects at all stages of development (Ph1-4) and be able to influence team strategy using modelling expertise.
- Be pivotally involved in the hands-on analysis and interpretation of clinical PK/PD data, integrating clinical trial simulation strategies and disseminating the relevant risk/benefit implications to the Company's project development teams.
- 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, both direct reports and 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
- Maintaining and establishing relationships and agreements with contract vendors
- 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
- 12+ years of experience and a PhD, PharmD or MD degree with emphasis in Clinical Pharmacology, Pharmacokinetics or a closely related scientific discipline
- Experience in developing and implementing clinical pharmacology and modeling/simulation strategies for novel modalities (example: mAbs, antibody drug conjugates, bi-specifics, cell therapy, etc) and deliver life-saving medicines
- Proven track record of extensive experience in population modeling and simulations. Expertise with standard modelling and simulation software (NONMEM, S-Plus/R, etc) is required. Knowledge of other software - e.g. WinNonlin required
- 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
- 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
- Previous Virology and/or Oncology therapeutic area experience
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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.Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.\u200b
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