Director, Clinical Development (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 MD, at Gilead you will support or lead multiple components of clinical development programs in Inflammation/Fibrosis, including primary biliary cholangitis (PBC). You will provide scientific and clinical leadership across clinical trials and contribute to the development and global registration of a late-stage therapeutic.

You will be accountable for clinical development activities across assigned projects, including study design and execution, medical monitoring, interpretation and communication of clinical data, regulatory documentation, and scientific publications and presentations. The role also contributes to postmarketing requirements and other clinical development commitments.

Clinical Development and Study Leadership

• Provide medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance.
• 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 and the development of clinical study reports.
• Contribute to or lead development of the Target Product Profile and Clinical Development Plan for assigned molecules or products.
• Support clinical development activities associated with global registration of a late-stage therapeutic, including execution of clinical postmarketing requirements and other development commitments.

Clinical Data and Scientific Evidence

• Coordinate the collection and assimilation of ongoing clinical data for internal analysis and review.
• Contribute to data analysis planning and the synthesis of data from Phase 3 and other clinical studies.
• Coordinate and manage the preparation and review of data listings, summary tables, study results, and scientific presentations.
• Translate clinical evidence into clear scientific materials for internal and external stakeholders.

Regulatory and Scientific Communication

• Provide clinical development input into regulatory documentation and responses to health authority inquiries.
• Lead or contribute to preparation and review of regulatory documents, investigator brochures, and development plans.
• Contribute to clinical publications and scientific presentations.
• Present scientific information at scientific conferences and clinical study investigator meetings.
• Conduct clinical development activities in accordance with applicable regulatory requirements, Good Clinical Practice, and Gilead standard operating procedures.

Cross-Functional Leadership

• Lead clinical development deliverables across cross-functional project and program teams.
• Manage multiple clinical project priorities and deliverables through matrix leadership.
• Communicate project direction, clinical findings, and status to stakeholders at different organizational levels, including leadership teams, executives, and steering committees.
• Apply clinical and scientific judgment to support project decisions within assigned programs.
• Travel when needed to support the responsibilities of the role.

Basic Qualifications

MD or equivalent with 4+ years’ clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment

Preferred Qualifications

• Experience in the biopharmaceutical industry.
• Clinical, scientific, and/or drug development experience relevant to clinical development.
• Experience providing medical monitoring in clinical development, including familiarity with medical concerns arising during clinical trials.
• Experience working with and leading cross-functional project or program teams in life sciences, healthcare, consulting, or academia.
• Experience leading or contributing to study concept and protocol design, regulatory filings, clinical publications, and scientific presentations.
• Experience managing multiple clinical project deliverables and priorities through matrix leadership.
• Demonstrated knowledge of pharmaceutical regulatory requirements and their impact on clinical trial development and execution.
• Relevant expertise in the assigned or a related disease area sufficient to independently lead clinical development deliverables for one or more projects.
• Analytical capability demonstrated through relevant professional or academic research experience.
• Ability to communicate clinical and scientific information and project direction to stakeholders across organizational levels.
• Ability to manage detailed, time-sensitive clinical development activities.
• 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.

 

 

 

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:

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.
 

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.