Senior Director, Clinical Pharmacology, Oncology

Location: Foster City, California US

Notice

This position is no longer open.

Job Number: 1480

External Description: Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.

Job Description
As a Senior Director within the Clinical Pharmacology Group at Gilead, you will have ultimate 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.

Your tasks and responsibilities will include;

  • 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


Specific education, experience and skills required for this role;

  • At least 10 years' experience and a, PhD, PharmD or MD degree with emphasis in clinical pharmacology, pharmacokinetics or a related scientific discipline
  • 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


About Gilead

We are committed, hardworking and passionate about improving the lives of the patients who use our products. We challenge one another to ever higher standards and accomplishment. Gilead has attracted some of the sharpest minds in biotech and beyond, and the people who thrive in our culture are those who seek opportunities to do their best work beside others who share the same mission.

Being here matters. Together we deliver life-saving therapies to patients in need. We are committed and driven to change the world and help millions of people live healthier, more fulfilling lives.

Our worldwide staff of more than 12,000 people is a close community where you can see the tangible results of your contributions, where every individual matter, and everyone has a chance to enhance their skills through ongoing development.

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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 careers@gilead.com for assistance.

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Number: R0013092

Community / Marketing Title: Senior Director, Clinical Pharmacology, Oncology

Location_formattedLocationLong: Foster City, California US

 

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