VP, NonClinical Safety and Pathobiology

Key Responsibilities

• Nonclinical Safety and Pathobiology (NSP) group is responsible for design, implementation, oversight and analysis of nonclinical programs to support drug development candidates from research to registration.
• NSP group is comprised of Toxicology, Pathology, and Environmental / Occupational Toxicology.
• NSP is responsible for ensuring patient safety of Gilead drug candidates through exhaustive non-clinical evaluations.
• NSP is responsible for ensuring global compliance with worldwide regulations governing the conduct of Gilead's nonclinical studies in support of global clinical trials, registration, and new drug approvals.
• NSP is responsible for Pathobiology characterization of animal models and clinical specimens as needed to advance translational understanding of new targets and new therapeutics.
• Manages and mentors a group of Ph.D. level toxicologists and pathologists to ensure NSP continues to develop and implement cutting edge scientific technologies and drug development strategies.
• Prepares and reviews regulatory documents including INDs/IMPDs, Investigator Brochures and NDAs/MAAs.
• Communicates successfully cross-functionally to accomplish Company goals.
• Solves highly complex problems requiring evaluation of business intangibles in addition to thorough scientific assessment.

Knowledge

• Experience in successful conduct of nonclinical programs as well as preparation, submission and approval of nonclinical sections of regulatory filings covering all stages of development.
• Has an in-depth knowledge of nonclinical drug discovery and development and regulatory environments in the US, EU and AsiaPac.
• Individual is recognized as an expert in the field both inside and outside of the company.
• Possesses strong leadership/management abilities and is highly effective on teams.
• Possesses strong organizational skills, technical excellence, scientific creativity and critical thinking ability.
• Maintains broad knowledge of scientific discipline. Expected to provide oversight of the following areas:
• Discovery support screening studies for candidate selection
• Development support GLP toxicity studies (to enable IND/IMPD and NDA/MAA submissions)
• Preparation of nonclinical regulatory documentation
• Issue resolution
• Qualification of impurities
• Environmental assessments

Specific Education and Experience Requirements

Requires a Ph.D in pharmacology/toxicology/pathology or related scientific discipline, together with a significant amount of experience that has led to a reputation as a leader in the field.

• DABT and/or DACVP and/or ERT preferred.
• Knowledge of global regulatory guidelines associated with quality and compliance in the conduct of nonclinical safety studies is required.
• Should have at least 20 years of experience in research or development in a pharmaceutical company or contract research organization.
• Ability to collaborate across a global network of stakeholders to ensure delivery of drug candidates.

People Leader Accountabilities

• Create Inclusion - knowing the business value of diverse teams, modelling inclusion and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

Your Rights Under the Family and Medical Leave Act

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

• Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
• Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors

Please apply via the Internal Career Opportunities portal in Workday.