Skip to main content

This job has expired

You will need to login before you can apply for a job.

Director, Clinical Development HIV Prevention (MD)

Employer
Gilead Sciences, Inc.
Location
Foster City, CA
Start date
Mar 18, 2023

View more

Job Details

Director, Clinical Development HIV Prevention (MD)
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
Job Description



POSITION OVERVIEW:

You will typically lead multiple components of clinical trial programs in HIV clinical development. You will help design, conduct, and evaluate Phase 1, 2, and 3 clinical trials and provide expertise in clinical HIV medicine. You will primarily be involved in developing long-acting drugs for HIV prevention and may also support programs for HIV treatment and for HIV cure research. Working in collaboration with the HIV Prevention Global Development Team Lead, 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.

EXAMPLE RESPONSIBILITIES:
  • Provides input into or leads the development of the Target Product Profile and Clinical Development Plan for assigned molecules /products
  • 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 protocol design, clinical study reports and 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
  • 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


REQUIREMENTS:

We are all different, yet we all use our unique contributions to do the work. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience
  • MD or equivalent with 4+ years' clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia, or a related environment
  • Board certification in Internal Medicine and Infectious Diseases is preferred, including familiarity with HIV treatment and prevention care
  • Direct experience in the strategic, and tactical implementation of drug development 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
  • Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership
  • Experience with engaging internal and external expert physicians, scientists, and other key stakeholders, including community and civil society leaders, in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results
  • Successful leadership and program management experience
  • Experience in business development and assessment of opportunities is desired


Knowledge & Other Requirements
  • Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving.
  • Ability to think analytically and strategically to formulate, develop, and execute clinical plans.
  • Well-developed sense of integrity, strong work ethic, strong ttention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality.
  • Excellent scientific written and oral communication and interpersonal skills are required.
  • Must be capable of working with attention to detail in a time sensitive environment.
  • Strong familiarity with good clinical practices and International Conference on Harmonization Guidelines is required.
  • Experienced with Microsoft Office (Excel, PowerPoint, etc.) as well as job related programs such as Spotfire and RDMS
  • Ability to partner, influence and inspire others.
  • Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (~up to 20% travel expected).
  • Proven analytical abilities as demonstrated through past experience and/or academic research.
  • Has core expertise in HIV prevention and/or treatment and infectious diseases, as evidenced by ability to independently lead clinical development for deliverables for one or more projects.
  • Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
  • Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.

For jobs in the United States:


As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

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

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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 log onto your Internal Career Site to apply for this job.






jeid-88d802bcf24bc54bb2db29c92b98d0d2

Company

Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
 

Company info
Website
Location
333 Lakeside Drive
Foster City
California
94404
United States

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert