Sr Director, Clinical Pharmacology

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

EXAMPLE RESPONSIBILITIES:

• Lead the design and conduct of a broad portfolio of multiple, complex clinical pharmacology strategies and studies for an assigned disease or portfolio in the inflammation therapeutic area.

• Author, oversee, and evolve clinical pharmacology strategies and plans, including Clinical Pharmacology Plans (CPPs) in partnership with members responsible for bioanalysis, pharmacometrics, regulatory, clinical development, etc. for assigned products or portfolios

• Lead or oversee multiple CPSTs and provide matrix leadership across project teams responsible for the largest and most complex products.

• Act as the Clinical Pharmacology lead on highly complex projects and advise leadership teams and steering committees on overall clinical pharmacology strategy, key decision points, trade-offs, and risks.

• Provide strategic direction for clinical pharmacology study design, study execution, PK-PD and related analyses, interpretation, and reporting in support of clinical development and regulatory submissions.

• Represent Clinical Pharmacology in Product Strategy Teams, governance and decision-making forums, and selected health authority interactions as needed.

• Develop and manage resource plans, budgets, priorities, and external support models for the assigned area.

• Build and maintain thought leader and external relationships that inform short- and long-range R&D and clinical pharmacology strategies.

• Coach senior colleagues and cross-functional partners, and raise standards across projects and teams through clear expectations, strong stakeholder management, and effective matrix leadership.

• Identify and lead strategic initiatives that improve methodologies, processes, practices, or ways of working across multiple teams.

REQUIREMENTS:
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.

Minimum Education & Experience

• PharmD, PhD, MD, or other advanced degree in pharmaceutical sciences, pharmacology, medicine, or a related discipline with substantial relevant experience in clinical research, drug development, or related life sciences work.

• Typically 10+ years with PharmD/PhD, 6+ years with MD, or an equivalent combination of advanced education and progressively responsible experience; broader degree/experience combinations may also be considered.

• Multiple years of experience leading high-complexity clinical pharmacology or related strategies and plans in life sciences, healthcare, consulting, or academia; experience in the biopharma industry is strongly preferred.

• Demonstrated experience leading large and complex drug development teams and influencing cross-functional strategy across a portfolio of projects.

• Experience interacting with and presenting to executives and managing large-scale budgets and other resources is strongly preferred.

Knowledge & Other Requirements

• Expert-level knowledge of drug development, with a proven track record in shaping short- and long-range strategies and plans across Phase I–IV studies.

• Broad expertise spanning the physiological and pharmacological aspects of drugs, biomarkers, pharmacogenomics, companion diagnostics, and novel approaches to drug development.

• Deep understanding of pharmaceutical regulatory requirements and their impact on development and execution of clinical trials, including strong familiarity with global health autho