Hiring company: Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Sr. Director, Clinical Pharmacology
As a Senior Director within the Clinical Pharmacology Group at Gilead, you will have ultimate responsibility and accountability for clinical pharmacology programs for the Virology 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
Minimum Qualifications:
10+ 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
Preferred Qualifications:
Previous Virology therapeutic area experience
For Colorado Job Applicants: The salary range for this position is:
Gilead considers a range of factors, including background and experience, when determining base compensation. These considerations means actual compensation will vary.
Position is also eligible for bonus and benefits. For more information, visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing