Associate Director, Clinical Site Partner, Clinical Operations

Associate Director, Clinical Site Partner, Clinical Operations
United States – Remote

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.

Job Description


Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead's products.

You will be responsible for establishing and maintaining relationships with active and potential investigator sites to optimize delivery of clinical trial programs for an assigned therapeutic area, inclusive of site identification and qualification, enrollment planning and execution, timely delivery of database lock and study close out. You will also serve as an effective communication bridge between investigator sites and the Gilead Development organization and a point of escalation for both Gilead and investigator site staff, including partnering with Gilead and investigator site staff to resolve issues and remove barriers as needed. You will also be responsible for establishing and managing relationships with regional / local patient advocacy groups (PAGs) and communities ensuring incorporation of the patient perspective and voice across the continuum of product development.

Additional local responsibilities may be required as needed/appropriate for the local geography.

EXAMPLE RESPONSIBILITIES:

• Establish and maintain strong professional and collaborative relationships with investigator sites by leveraging disease area expertise to optimize delivery of clinical trial programs.
• Develop strategies to drive concierge level support for preferred sites to ensure Gilead becomes the Sponsor of Choice.
• Track key performance metrics to assess site performance and identify opportunities for acceleration and continuous improvement.
• Establish and manage strong working partnerships with local PAGs and communities, including liaising with patient groups in relation to protocol development and study design considerations.
• Serve as an internal resource to champion and promote an environment that incorporates the patient perspective and voice across the continuum of product development based on patient insights obtained from local PAGs and communities.
• Identify investigator sites, PAGs and communities in alignment with portfolio strategy and priority to expand Gilead's clinical research partnership network.
• Maintain therapeutic and technical expertise to enable scientific discussions with the investigator and site personnel.
• Share ongoing information with investigators, PAGs and communities regarding Gilead's development pipeline and collect and report field-based intelligence in relation to competitive landscape, patient treatment pathways and other operational considerations that may impact Gilead's clinical trial program.
• Provide support to study teams and Clinical Research Organizations (CROs) to ensure timely delivery of clinical trials from initiation to closeout such as during feasibility, site recommendations, attendance at initiation visits, facilitation of communication and ongoing support of trial enrollment by engaging with site staff to identify enrollment barriers and working with study teams to find solutions.
• Support the development and implementation of applicable site risk plans to ensure achievement of key study and site level milestones such as first patient first visit, delivery of clinical trial enrollment commitments and database lock.
• Serve as a local point of escalation for investigator sites and partner with the appropriate parties to resolve issues and remove barriers to clinical trial execution at a site and/or country level.
• Proactively communicate and escalate issues identified at investigator sites and partner with internal functional areas to develop corresponding mitigation strategies and recommended approaches, including participation in development and implementation of solutions to address issues.
• Leverage and present metrics to inform site / country / regional level decision making.
• Develop local knowledge of investigator site capabilities and past performance and provide input into site-level recruitment forecasts, recruitment methodologies, monitor performance and take appropriate action to maintain timelines.
• Partner closely with internal Clinical Operations, Clinical Development and Medical Affairs to ensure effective communication and unified messaging to investigator sites, PAGs and communities.

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

• BA / BS / RN with 10 or more years' relevant clinical or related experience in life sciences. Or, MA / MS / PharmD / PhD with 8 or more years' relevant clinical or related experience in life sciences.
• Combination of scientific/medical expertise in a relevant therapeutic area, including knowledge of the clinical research landscape, and advanced knowledge of Clinical Operations. ​
• Strong working knowledge of Good Clinical Practice and in country regulatory guidelines and requirements.

Knowledge & Other Requirements

• Strong self-management and organizational skills; ability to manage workload, set priorities and adjust as needed.
• Ability to work both independently and collaboratively.
• Excellent verbal and written communication and oral presentation skills (both in English and local language).
• Ability to establish and maintain strong long-term relationships with internal and external key stakeholders.
• Strong interpersonal skills and understanding of team dynamics.
• Strong leadership presence with demonstrated ability to lead without authority at all levels of internal and external stakeholders.
• Strong negotiation and conflict resolution skills.
• Demonstrated strategic agility and broad business acumen.
• Possess a combination of critical thinking and operational expertise and efficiency.
• Self-motivated with proactive issue monitoring and seeks opportunities to remove barriers.
• Extensive travel required (50%)

For Colorado Job Applicants: The salary range for this position is:
$154,320.00 - $231,480.00
Gilead considers a range of factors, including background and experience, when determining base compensation. These considerations means actual compensation will vary.
Position is also eligible for bonus and benefits. For more information, visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing

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 'EEO is the Law' 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.






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