Director, Clinical Operations

Regulatory Jobs; Foster City (CA); Presencial; USD 210.000 - 272.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Benefits package

Descripción de la vacante

Gilead Sciences Inc. in Foster City, CA or Parsippany, NJ is seeking a senior clinical trials leader to oversee international Phase I–IV programs across multiple indications, with CROs and internal resources.

Extensive regulatory and scientific leadership is required, including budget oversight, strategic direction, SOP development, and cross-functional collaboration. Travel awareness and mentorship of staff are key components.

Formación

• 12+ years of experience and a BS in a relevant scientific discipline.
• 12+ years of relevant experience and a MS degree.
• 14+ years of experience and an RN (2 or 3 year certificate)

Responsabilidades

• Provides leadership and therapeutic expertise for the successful management of international clinical trials (Phase I - IV) across multiple indications through clinical study teams and through the use of CROs or internal resources.
• Responsible for oversight and strategic direction and implementation across a number of projects to ensure clinical programs are conducted to meet project milestones and budgets through close partnership with parties involved both inside and outside of the company.
• Initiates continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among teams.
• Directs development of SOPs within department and participates in development of collaborative SOP development.
• May contribute to Clinical Study Reports, INDs, NDAs, and other clinical/regulatory/safety documents.
• Contributes to development of abstracts, presentations, and manuscripts.
• Manages study teams to ensure deployment of resources.
• Travels nationally and internationally as required.
• Represents the company at professional events and may present company clinical initiatives and findings at such events.
• Extensive clinical experience is required.
• Excellent verbal, written, interpersonal skills, and ability to lead multifunctional teams, ability to manage staff, and mentor junior staff is required.
• Must be able to solve complex problems and use highly developed independent judgment relating to national and international regulations, guidelines, investigator interactions and timelines.
• Must be able to successfully develop, implement, manage and complete complex clinical trials and manage vendor relations.
• Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of complex problems.
• Demonstrated excellence in complex project management and effectively managing multiple projects/priorities is required.
• Experience managing cross-functional teams or work groups as well as direct reports.
• Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials is required.
• Experience with presentations before executive staff.
• Extensive experience in developing RFPs, selection of CROs/vendors, and management of external resources is required.
• Demonstrated ability to manage international clinical trials within designated program budgets and timelines is required.
• Demonstrated ability to manage budgets.
• Proven ability to effectively communicate scientific, medical, and organizational concepts to internal and external customers.
• Ability to initiate, and lead departmental or interdepartmental strategic initiatives.

Conocimientos

Leadership

Regulatory strategy

Cross-functional leadership

Clinical trials management

Project management

Communication

Educación

BS in a relevant scientific discipline

MS degree

RN (2 or 3 year certificate)

Descripción del empleo

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

Specific Education & Experience Requirements:

• 12+ years of experience and a BS in a relevant scientific discipline.
• 12+ years of relevant experience and a MS degree.
• 14+ years of experience and an RN (2 or 3 year certificate)
• Prior experience leading and overseeing oncology clinical trials with a minimum of 5 years’ experience in the design and delivery of Phase 1 first in human (FIH) oncology clinical trials

Specific Job Responsibilities:

• Provides leadership and therapeutic expertise for the successful management of international clinical trials (Phase I - IV) across multiple indications through clinical study teams and through the use of CROs or internal resources.
• Responsible for oversight and strategic direction and implementation across a number of projects to ensure clinical programs are conducted to meet project milestones and budgets through close partnership with parties involved both inside and outside of the company.
• Initiates continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among teams.
• Directs development of SOPs within department and participates in development of collaborative SOP development.
• May contribute to Clinical Study Reports, INDs, NDAs, and other clinical/regulatory/safety documents.
• Contributes to development of abstracts, presentations, and manuscripts.
• Manages study teams to ensure deployment of resources.
• Travels nationally and internationally as required.
• Represents the company at professional events and may present company clinical initiatives and findings at such events.
• Extensive clinical experience is required.
• Excellent verbal, written, interpersonal skills, and ability to lead multifunctional teams, ability to manage staff, and mentor junior staff is required.
• Must be able to solve complex problems and use highly developed independent judgment relating to national and international regulations, guidelines, investigator interactions and timelines.
• Must be able to successfully develop, implement, manage and complete complex clinical trials and manage vendor relations.
• Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of complex problems.
• Demonstrated excellence in complex project management and effectively managing multiple projects/priorities is required.
• Experience managing cross-functional teams or work groups as well as direct reports.
• Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials is required.
• Experience with presentations before executive staff.
• Extensive experience in developing RFPs, selection of CROs/vendors, and management of external resources is required.
• Demonstrated ability to manage international clinical trials within designated program budgets and timelines is required.
• Demonstrated ability to manage budgets.
• Proven ability to effectively communicate scientific, medical, and organizational concepts to internal and external customers.
• Ability to initiate, and lead departmental or interdepartmental strategic initiatives.

This role can be based at our site in Foster City, CA or Parsippany, NJ

The salary range for this position is: $210,375.00 - $272,250.00. 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 [e-mail] 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.