Director, Clinical Development (MD)

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

In this role, you will lead or contribute to multiple aspects of clinical development programs within the Virology Therapeutic Area. Working as part of a cross-functional team, you will typically lead one or more components of Virology Clinical Development programs, including those in Respiratory/Emerging Viruses. For the assigned projects, you are accountable for various aspects of ongoing clinical trial program-related activities. These activities include, but are not limited to, study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, clinical development inputs into regulatory documentation, publications, and scientific presentations, pandemic preparedness, and outbreak responses to emerging viruses.

KEY RESPONSIBILITIES:

• Provides scientific and clinical expertise to cross-functional teams to support clinical development project deliverables and timelines, including but not limited to Respiratory/Emerging Viruses as well as pandemic preparedness and/or emerging outbreak responses.
• Contributes to the development and review of clinical trial protocols, clinical study reports, and responses to health authority inquiries.
• Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
• Contributes to the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures, and development plans.
• Supports the collection, review, and interpretation of clinical data for internal analysis and decision-making.
• Manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
• Presents scientific and clinical information at investigator meetings, internal forums, and scientific conferences.
• Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.

Basic Qualifications:

MD and Four Years' Experience

Preferred Qualifications:

• Clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment; Experience in the biopharma industry is preferred, with clinical experience in medical monitoring. Training and/or experience in Infectious Diseases, Immunology, Pulmonology, or a related medical specialty, and familiarity with emerging viruses and/or pandemic preparedness.is preferred.
• Significant experience working on, with and leading cross-functional project/program teams in life sciences, healthcare, consulting or academia.
• Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations.
• Experience presenting scientific or clinical data through publications, abstracts, posters, presentations, or other scholarly activities is preferred.
• Experience collaborating across multidisciplinary teams in academic, clinical, research, or industry settings is preferred.
• Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership.
• Demonstrated ability to learn quickly and apply new concepts in a fast-paced environment.
• Demonstrated flexibility and adaptability, with the ability to manage multiple priorities and contribute across projects as needed.
• Strong analytical and critical thinking skills, as evidenced through clinical practice, research, academic training, or other professional experiences.
• Foundational understanding of the drug development process and clinical research, or a strong interest and aptitude for learning these areas.
• Understanding of FDA and EMA regulations, ICH guidelines, GCP, and standard clinical research principles is preferred but not required.
• Strong scientific and medical knowledge, with the ability to critically evaluate and interpret clinical and scientific data.
• Excellent communication, presentation, organizational, and interpersonal skills.
• Ability to work effectively in a collaborative, cross-functional environment.
• Willingness and ability to travel as 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 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

The salary range for this position is: $261,375.00 - $338,250.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

* 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 View email address on gilead.yello.co for assistance.

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

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.