Job Description
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.
We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.
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.
As a Clinical Trials Manager, Biomarker/Bioanalytical Operations, You will work with and collaborate with Clinical Operations, Biomarker Sciences, Clinical Pharmacology and other cross-functional team members. You will manage certain components of clinical studies and act as a member of the study team. You will also manage biomarker and bioanalytical vendors. You will assist in the review of clinical study protocols and other study documents, contribute to process development and/or participate in special projects. You may also participate in strategic initiatives
Key Responsibilities:
- Serves as the key biomarker and bioanalytical operational (BBOps) contact with internal and external stakeholders, for successful implementation ofbiomarker and bioanalytical strategies in Gilead (GS) and Collaborative (CO) programs
- Participate in multiple Phase 1-4 clinical study teams
- 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), Biomarker SubTeams (BSTs), and Clinical Pharmacology Subteams (CPST)
- 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.
- Primary interface for operational activities between the SMT and laboratory vendors; Provides the day-to-day operational management of vendors to ensure delivery data 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, Vendor Outsourcing, 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 and Bioanalytical operational meetings with study functional groups or vendors
- 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
- 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
- Able to examine functional issues from an organizational perspective
- May contribute or participate in special projects.
- Develops tools and processes that optimize project efficiencies and effectiveness.
- 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
- Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
- Must have a general, functional expertise to support Process development and implementation
- Provides knowledge and expertise on country specific regulations
- Participates in and manages project meetings and conference calls with vendors and cross-functional teams.
- Develops tools and processes that optimize project efficiencies and effectiveness.
- Provides input into study protocols and case report forms, authors informed consents, study plans, and presentations.
- May be required to present at internal or external meetings (i.e., investigator meetings).
- Leads or otherwise assists in the preparation of interim and final study reports, including resolving any data discrepancies when biomarker data isneeded for primary, secondary or support.
- Proactively identifies potential operational challenges and collaborates with other Clinical Operations’ colleagues to provide solutions to ensure study execution remains on track to defined protocols, budgets and timelines.
- Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
- Travel may be required.
Basic Qualifications:
Bachelor's Degree and Five Years' Experience
OR
Masters' Degree and Three Years' Experience
People Leader Accountabilities:
- Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
- Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
- Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem
