Associate Director, Clinical Operations Oncology

Associate Director, Clinical Operations Oncology
United States - California - Foster CityUnited States - New Jersey - Morris PlainsUnited States - Washington - Seattle

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


Clinical Operations is responsible for the execution of Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead's products.

Led by a team of well-established Clinical Operations professionals, careers within the Clinical Operations team offers individuals the opportunity to develop their knowledge & experience rapidly whilst enjoying a supportive and team-focused working environment. Gilead's operational model allows each Clinical Operations professional to make a genuine impact on the business and ultimately our ability to deliver live changing therapeutics to those in need.

Specific Responsibilities and Skills for Position:

• Provides leadership and oncology expertise for the successful management of international clinical trials
• Contributes to the strategic implementation of a clinical development program(s)
• Demonstrated ability to manage international phase oncology clinical trials within designated program budgets and timelines is required
• Must possess a proven ability to effectively communicate scientific, medical, and organizational concepts to internal and external customers
• Extensive experience in developing RFPs, selection of CROs/vendors and management of external resources is required
• Ability to initiate, participate in and/or lead departmental or interdepartmental strategic initiatives
• Participates in development of SOPs, Clinical Study Reports, INDs, NDAs and other clinical, regulatory and safety documents
• Provides input into the management of the Clinical Operations department
• Effectively solves problems and uses judgment relating to national and international regulations, guidelines, investigator interactions and timelines
• Recruits, hires, mentors and manages Clinical Trial Manager/Clinical Program Manager/Clinical Trial Management Associate direct reports and supports their professional development
• Leads cross-functional study management team and must have good influencing skills with study stakeholders
• Travels nationally and internationally as required

Knowledge & Other Requirements

• Excellent interpersonal skills, and demonstrated ability to lead is required
• Oncology development experience
• Experience in managing staff as well as mentoring and developing junior staff is required
• Strong communication and influence skills and ability to create a clear sense of direction is necessary
• Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction
• Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials
• Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required.
• Experience in developing RFPs and selection and management of CROs/vendors
• Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents (e.g. IND, NDA, etc.) with little supervision
• Ability to examine functional issues from a broader organizational perspective.
• Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision
• Functional expertise to initiate, author, or contribute to SOP development, implementation, and training
• Has an expert-level of knowledge of one or more disease or therapeutic areas, as evidenced by independence in assuming study management leadership and oversight for multiple clinical studies across a worldwide clinical program.
• Routinely drives to resolve cross-functional issues related to study execution.
• Lead by Example leadership mentality
• Typically reports to Director or above.
• Provides matrix management and leadership to multiple larger-scale study teams.
• Acts as a process improvement and innovation champion; identifying opportunities to enhance operational excellence / innovation and staff to drive initiatives, e.g., tech and innovation collaborations. Drives and/or leads departmental and interdepartmental strategic initiatives.
• Actively contributes and may represent Clinical Operations in project strategy meetings or Global Development Team (GDT) as applicable.
• Actively consults on short- and long-term TA / FA strategy and operational plans as appropriate, including consistent messaging upon implementation.
• Leads highly complex assignments that enable multiple functions, teams and therapeutic area clinical programs to achieve their objectives within targeted timelines and allocated resources.
• Champions our Leadership Commitments and Values with an appropriate balance of portfolio delivery, resource management, and organizational excellence / innovation while being able to effectively manage more complex assignments.
• With little to no direction, determines how to structure and manage assigned studies across a program(s) to ensure project deliverables are completed on-time, within-budget and to the quality expected
• Develops change management skills in other team members by providing proactive change management leadership and guidance.

Required Education & Years of Experience and Skills:

• 10+ years of experience in clinical operations and a BS/BA or higher degree in a relevant scientific discipline. MS/MA or higher will need 8+ yrs experience in clinical operations
• Minimum of 6 years' cross-functional study management or related leadership experience in life sciences, including multiple years' experience managing study management or project teams.
• Experience in company sponsored clinical trial management is required
• Oncology development experience required

The salary range for this position is: $185,895.00 - $240,570.00. 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.

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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.

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For Current Gilead Employees and Contractors:

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






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