Oncology Early Stage Clinical Scientists

Hybrid – Bay Area, CA

6-Month Initial Contract

Position

We are seeking multiple Clinical Scientists to work collaboratively with Clinical Research, Pharmacovigilance, and Clinical Operations in the execution of one or more clinical trials or significant aspects thereof. In these roles, you will have the opportunity to demonstrate your leadership, technical skills, and scientific acumen as part of a cross-functional clinical development team. Responsibilities include overseeing data validation, managing data queries, and ensuring the integrity of trial data. Working closely with other functional disciplines, including Clinical Operations, Biostatistics/Data Management, Clinical Pharmacology, Translational Oncology, and Biomarkers, you will help ensure that all aspects of Oncology Early Stage Development (OESD) are effectively represented within clinical study teams. These roles require an onsite presence of 2-3 days a week.

Responsibilities

• Lead specific aspects of clinical and scientific execution for early phase (Phase 1) oncology trials, including protocol development, medical monitoring, and cross-functional collaboration.
• Collaborate with Clinical Operations and cross-functional teams to ensure timely, high-quality trial execution, focusing on data quality, safety, and integrity.
• Design and review study-related materials, including clinical protocols, informed consent forms, case report forms (CRFs), and amendments to align with trial objectives.
• Conduct data review, analysis, and interpretation in collaboration with Biostatistics, Clinical Safety, and Pharmacovigilance teams to support proof-of-concept outcomes.
• Perform regular safety reviews, documenting individual subject and cumulative safety data in alignment with the Safety Review Plan.
• Assist in developing presentations, abstracts, and manuscripts for clinical data dissemination, including regulatory documents and publications.
• Partner with Translational Oncology and Biomarkers to incorporate biomarker strategies into trials for efficacy indicators, patient stratification, and proof-of-concept assessments.
• Support consistent data review techniques and clinical analysis across studies, proactively identifying and mitigating risks to trial success.
• Provide scientific mentorship and guidance to junior clinical scientists on clinical protocols and data review practices.

Qualifications

• Minimum of 4 years of experience in clinical development, specifically in oncology drug development, with a focus on early-phase (Phase 1) studies.
• Demonstrated understanding of clinical trial design, execution, and regulatory requirements, including GCP and ICH guidelines.
• Proven scientific writing skills and excellent communication skills, with the ability to effectively engage and influence stakeholders across Clinical Development functional areas.
• Experience with data listing review and strong analytical skills to interpret clinical trial data and synthesize conclusions.
• Strong interpersonal skills and ability to work collaboratively in a fast-paced, matrixed team environment, with a proactive and strategic approach to meeting clinical study goals.
• Proficient in generating and authoring clinical trial documents, such as medical monitoring plans, statistical analysis plans, informed consent forms, and clinical study reports.
• Demonstrated ability to build consensus and drive change across all levels of the organization, including senior management, and to manage competing priorities with strong planning and time-management skills.
• Experience in oncology and familiarity with related disciplines (e.g., biostatistics, regulatory, preclinical pharmacology, pharmaceutical sciences) is preferred.

Oncology Early Stage Clinical Scientists