Director, Clinical Development Non-MD

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 our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

As a Director Clinical Development Non-MD, at Gilead you will support or lead multiple components of clinical development programs in inflammation and fibrosis, including primary biliary cholangitis (PBC). You will contribute to late-stage clinical development activities, including the synthesis of Phase 3 and other study data, activities supporting global registration of a late-stage therapeutic, execution of clinical postmarketing requirements, and other clinical development commitments.

Clinical Development and Study Leadership

• Support or lead clinical development activities across assigned projects, including protocol preparation, study documentation, data analysis planning, study reporting, publications, and scientific presentations.
• Provide scientific and clinical guidance to cross-functional teams to support clinical development deliverables and timelines.
• Provide input into, or lead, clinical trial protocol design, clinical study reports, and responses to health authority inquiries.
• Provide input into or lead development of the Target Product Profile and Clinical Development Plan for assigned molecules or products.

Clinical Study Oversight and Data Review

• Provide ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance.
• Coordinate the collection and synthesis of ongoing clinical data for internal analysis and review.
• Coordinate and manage the preparation and/or review of data listings, summary tables, study results, and scientific presentations.
• Contribute clinical development expertise to data analysis plans and the interpretation and synthesis of data from Phase 3 and other clinical studies.

Regulatory and Scientific Deliverables

• Support activities associated with global registration of a late-stage therapeutic in clinical development.
• Assist with execution of clinical postmarketing requirements and other clinical development commitments.
• Manage clinical development contributions to the preparation and review of regulatory documents, investigator brochures, and development plans.
• Present scientific information at scientific conferences and clinical study investigator meetings.
• Conduct clinical development activities in accordance with applicable regulatory requirements, Good Clinical Practice (GCP), and Gilead standard operating procedures.

Cross-Functional Leadership and Execution

• Lead or contribute to cross-functional project and program teams to deliver clinical development objectives.
• Manage multiple clinical development deliverables and priorities through matrix management and leadership.
• Communicate project direction and status across organizational levels, including leadership teams, executives, and steering committees.
• Apply analytical judgment and relevant disease-area expertise to clinical development activities and deliverables.

Basic Qualifications

• PharmD or PhD in clinical research or clinical pharmacology with 6+ years of scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia, or a related environment.

Preferred Qualifications

• Experience in the biopharma industry.
• Clinical experience in medical monitoring and familiarity addressing medical concerns.
• Experience working on and leading cross-functional project or program teams in life sciences, healthcare, consulting, or academia.
• Experience leading study concept and protocol design, regulatory filings, clinical publications, and presentations.
• Experience managing multiple clinical development project deliverables and priorities through matrix management and leadership.
• Understanding of pharmaceutical regulatory requirements and their impact on clinical trial development and execution.
• Relevant analytical experience demonstrated through professional experience and/or academic research.
• Expertise in the assigned or a related disease area sufficient to independently lead clinical development deliverables for one or more projects.
• Ability to communicate project direction and status across organizational levels, including leadership teams, executives, and steering committees.
• Ability to work with attention to detail in a time-sensitive environment.
• Ability to travel when needed.

People Leader Accountabilities

•Create Inclusion - knowing the business value of diverse teams, modeling 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, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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 ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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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.

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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.

About Us

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

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