Gilead Sciences

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.. These activities include, but are not limited to, study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations.. Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.. MD or equivalent with 6+ years’ clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.. Board certification in Gastroenterology is preferred, including familiarity with IBD management or inflammatory disease management

director clinical development

Sr Director, Clinical Development GI (MD) page is loaded     Sr Director, Clinical Development GI (MD)     Bewerben             locations  United States - California - Foster City         time type  Full time        posted on  Vor 3 Tagen ausgeschrieben        job requisition id  R0039870                                 For Current Gilead Employees and Contractors:                                                  Please log onto your Internal Career Site  to apply for this job.
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.We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.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. Join Gilead and help create possible, together.
Job Description   POSITION OVERVIEW:
You will typically lead multiple components of clinical trial programs in IBD/inflammation clinical development. You may also act as the Physician Responsible on certain projects. For the assigned projects, you are accountable or 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, and clinical development inputs 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 serve patients. Please see the following for the qualifications and skills we seek for this role.
Minimum Education & Experience
MD or equivalent with 6+ years’ clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
Board certification in Gastroenterology is preferred, including familiarity with IBD management or inflammatory disease management..
Experience in the biopharma industry 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.
Knowledge & Other Requirements
Proven analytical abilities as demonstrated through past experience and/or academic research.
Has core expertise in the assigned or related disease area, 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.
Has advanced knowledge of R&D and major disease areas, as evidenced by effectiveness supporting clinical projects.
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.
When needed, ability to travel.
Open to only WEST COAST candidates or candidates who are open to relocation.
The salary range for this position is: $295,290.00 - $382,140.00. 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:                                                  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     ApplicantAccommodations@gilead.com      for assistance.

For more information about equal employment opportunity protections, please view the                         'Know Your Rights'  poster.
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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.
Ähnliche Stellen (1)       Director, Clinical Development Inflammation (MD)         locations  United States - California - Foster City        posted on  Vor mehr als 30 Tagen ausgeschrieben
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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