Clinical Trials Manager, Biomarker Operations (CTM)

Foster City
See job description.
February 25 2021
R0017771
Other, Other
Full Time
Pharma
Manager


Clinical Trials Manager, Biomarker Operations (CTM)
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. Gileads 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 companys five core values. Thats 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


Clinical Operations is an organization committed to the strategic execution of clinical studies in support of Gilead's clinical development programs. Clinical Trials Management (CTM) ensures effective design, implementation and management of global clinical trials covering all of Gilead's Therapeutic Areas from Phase I-IV. The CTM teams work with our many internal and external partners to ensure our studies are carried out following all regulatory guidelines, protect the safety of Gilead's patients and generate high quality data in a cost-effective manner. The groups direct every step of the clinical study management process from initial protocol development and study startup through management and closeout activities, providing oversight and project management throughout the process.

Biomarker Operations is part of Clinical Operations and provides functional support, overseeing operational implementation and execution of the biomarker strategy in clinical trials across all of Gilead's Therapeutic Areas from Phase I-IV. The Biomarker Operations team plans and coordinates all operational activities required for the collection, delivery and analysis of biomarker samples within a clinical trial.

Clinical Trials Manager, Biomarker Operations (CTM)

Specific Responsibilities and Skills for Position:

- Serves as the key biomarker operational contact with internal and external stakeholders, for successful implementation of biomarker strategy in Gilead (GS) and Collaborative (CO) programs

- Participate in multiple Phase 1-3 teams to manage biomarker implementation in clinical trials

- Plans and coordinates all operational activities required with the collection, delivery and analysis of biomarker samples within a clinical trial

- Provides sample management expertise to the Study Management Teams (SMTs)

- Accountable for ensuring biomarker samples collected are of good analyzable quality and are collected in adherence to the highest standards of ethics and informed consent.

- Collaborate with biomarker biology to translate sample processing and handling instructions from research setting to the clinical setting

- Primary interface for operational activities between the SMT and biomarker laboratory vendors; Provides the day-to-day operational management of biomarker 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, CCF, 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 strategy remains on track

- Organizes and leads biomarker operational meetings

- Maintains internal Biomarker 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 budget

- May serve as a resource for others within the company for biomarker 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 required

Knowledge:

- 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 with Word, PowerPoint and Excel

Experience and Skills:

- At least 5+ years of experience and a BS/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) or

- At least 3+ years of experience and a Masters' degree or higher; scientific discipline preferred

-Clinical or biological laboratory experience with evidence of involvement in the

processing and/or analysis of biological samples is a plus

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.

For more information about equal employment opportunity protections, please view the EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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:

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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Clinical-Trials-Manager--Biomarker-Operations--CTM-_R0017771-1





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