Clinical Trials Manager, Clinical Operations- Biomarker and Bioanalytical
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 #CreatingPossibleFor Current Gilead Employees and Contractors:
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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 DescriptionSpecific Responsibilities and Skills for Position:
- Must meet all requirements for Sr. Clinical Trials Management Associate position and have demonstrated proficiency in all relevant areas
- Serves as the key biomarker and bioanalytical operational (BBOps) contact with internal and external stakeholders, for successful implementation of biomarker and bioanalytical strategies in Gilead (GS) and Collaborative (CO) programs
- Participate in multiple Phase 1-3 teams to manage biological specimen implementation in clinical trials
- Plans and coordinates all operational activities required with the collection, delivery and analysis of biological specimens within a clinical trial
- Provides sample management expertise to the Study Management Teams (SMTs)
- Accountable for ensuring biological samples collected are of good analyzable quality and are collected in adherence to the highest standards of ethics and informed consent.
- Collaborate with biomarker sciences and clinical pharmacology to translate sample processing and handling instructions from research setting to the clinical setting
- Primary interface for operational activities between the SMT and laboratory vendors; Provides the day-to-day operational management of vendors to ensure
delivery against contracted scope of work
- Has ability to critically evaluate scientific proposal or protocol, and budget for clinical operation feasibility
- Establishes strong cross-functional relationships and exhibits strong leadership skills with counterparts in other functional teams (e.g., Biomarker Sciences, Clinical Pharmacology, Business Development , Clinical Operations, and Data Management) to ensure efficient execution of the study biomarker strategy.
- Proactively identifies potential operational challenges and in collaboration with senior team members provides resolution plans to ensure biomarker and bioanalytical strategies remains on track
- Organizes and leads biomarker and bioanalytical operational meetings
- Maintains internal Biomarker and Bioanalytical Operations databases and document repositories
- Review of relevant documents including protocols, informed consents, and relevant study documents
- Must be able to understand, interpret and explain protocol requirements to others
- Creates and Maintains study timelines
- Assists in determining the activities to support a project's priorities within functional area
- Contributes to development of RFPs and participates in selection of CROs/vendors
- May be asked to train CROs, vendors, investigators and study coordinators on study requirements
- Contributes to development of biomarker and bioanalytical budget
- May serve as a resource for others within the company for biomarker and bioanalytical operations clinical trials management expertise
- Able to examine functional issues from an organizational perspective
- Participates in the recruiting and hiring process for CPA/CTMA/Sr. CTMA and support their professional development
- May contribute to development of abstracts, presentations and manuscripts
- Under supervision, may design scientific communications within the company
- Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
- Must have a general, functional expertise to support SOP development and implementation
- Collaborates with internal stakeholders on country specific studies and initiatives
- Provides knowledge and expertise on country specific regulations
- Travel may be requiredKnowledge:
- Excellent teamwork, communication, decision-making and organizational skills are required
- Thorough knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies
-Working knowledge and experience in companion diagnostics and/or China regulatory submissions
- Working knowledge and experience with Word, PowerPoint and ExcelExperience and Skills:
- At least 5+ years of experience and a BS or BA in a relevant scientific discipline (eg. Clinical Operations and/or Sample Management) or
- At least 5+ years of experience and an RN (2 or 3 year certificate)
-Clinical or biological laboratory experience with evidence of involvement in the
processing and/or analysis of biological samples is a plus
The salary range for this position is: $139,145.00 - $180,070.00. 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 ApplicantAccommodations@gilead.com
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For Current Gilead Employees and Contractors:
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