Description
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
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases
Clinical Trials Manager (CTM) Biomarker and Bioanalytical Operations
Specific 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 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 in companion diagnostics and/or China regulatory submissions.
- Working knowledge and experience with Word, PowerPoint and Excel.
Experience 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.
