Vp, Nonclinical Safety And Pathobiology

Gilead Sciences Inc.; Maryland; On-site; USD 180,000 - 280,000; Full time

Job summary

Gilead Sciences Inc. is seeking a senior leader in nonclinical safety to guide NSP programs from research to regulatory submission. The role requires directing a team of Ph.D.-level toxicologists and pathologists and shaping strategies across global clinical development pipelines.

Ideal candidates possess a Ph.D. in pharmacology/toxicology/pathology with 20+ years in pharma, and strong regulatory and cross-functional leadership across US, EU, and AsiaPac contexts.

Qualifications

• Ph.D. in pharmacology/toxicology/pathology or related field.
• DABT and/or DACVP and/or ERT preferred.
• 20+ years of pharmaceutical research or development experience.
• Knowledge of global regulatory guidelines for nonclinical safety studies.
• Ability to collaborate across a global network of stakeholders.

Responsibilities

• Design and oversee nonclinical programs from research to registration.
• Mentor Ph.D. level toxicologists and pathologists.
• Prepare regulatory documents (INDs/IMPDs, NDAs/MAAs) and ensure compliance.
• Communicate cross-functionally to achieve company goals.
• Solve complex problems at the intersection of science and business.

Skills

Leadership mentoring

Regulatory knowledge

Cross-functional collaboration

Strategic thinking

Education

Ph.D. in pharmacology/toxicology/pathology

Job description

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

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.

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.
• Solve 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.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 [e-mail] for assistance.

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