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
 

The Director, Clinical Development provides clinical leadership and input on clinical studies, supporting the HIV programs. You will typically lead or assist on multiple components of clinical trial programs in HIV clinical development. You will help design, conduct, and evaluate Phase 1-4 clinical trials and provide expertise in clinical hepatitis. You will primarily be involved in developing drugs for HIV treatment and cure. Working in collaboration with the Clinical Leads and Global Development Team Leads, you will be responsible for various aspects of ongoing clinical trial program-related activities within the HIV therapeutic area. These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical study start up/execution/close out, specifically including, medical monitoring, data analysis/reporting and support of Regulatory filings, and clinical development input into regulatory documentation, publications, and scientific presentations.

Key Responsibilities:

• This position reports to the Executive Director of HIV Treatment and Cure.
• Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
• Provides input into, or otherwise leads, clinical trial proto‐col design, clinical study reports and health authority inquiries. Provides ongoing clinical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
• Manages the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
• Coordinates the collection and assimilation of ongoing data for internal analysis and review.
• Coordinates and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
• Presents scientific information at scientific conferences as well as clinical study investigator meetings.
• Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
• Provides high level and complex scientific and clinical guidance to Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines.
• Primary responsibilities include providing high level input to complex Phase I-IV clinical trial protocol design and clinical study reports as well as Health Authority inquiries.
• Provides ongoing clinical monitoring for clinical trials including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
• Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
• Also manages the clinical research component in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and development plans.
• Coordinates the collection and assimilation of ongoing data for internal analysis and review.
• Coordinates and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
• Presents scientific information at scientific conferences as well as clinical study investigator meetings.
• Leads two or more specific components of cross-functional strategic initiatives.
• Excellent scientific written and oral communication skills are required.
• Must possess a proven ability to work highly effectively with multiple departments.
• Must be capable of working with attention to detail in a time sensitive environment.

Basic Qualifications:

• 12+ Years with BS/BA
  OR
• 10+ Years with MS/MA or MBA

Preferred Qualifications:

• Preference for MD/DO and 4+ years of clinical or biotech/pharma industry experience with a proven success record in clinical research studies, trial design, execution and oversight
• PharmD or PhD in clinical research or clinical pharmacology with 8+ years’ scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
• Relevant experience in HIV is preferred.
• Experience working on cross-functional project teams in a global development team
• Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations is preferred.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
• Proven analytical abilities as demonstrated through past experience and/or academic research.
• Understands drug development phases and the nature of associated clinical trials across phases.
• Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.
• Has advanced knowledge of R&D and major disease areas, as evidenced by effectiveness supporting clinical projects.
• Strong communication and organizational skills.
• When needed, ability to travel.
• Strong familiarity with good clinical practices and International Conference on Harmonization Guidelines is preferred.

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.
 

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For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.