Job Description

Senior Director, Clinical Research Scientist (Oncology)

Location: San Francisco Bay Area or San Diego (Hybrid/Remote Considered)

Contract: 18‑month engagement (High Likelihood of Extension)

Compensation: Competitive senior‑director‑level hourly rate

About the Opportunity

A clinical‑stage oncology biotechnology company is seeking an experienced Senior Director, Clinical Research Scientist (CRS) to support late‑stage clinical development activities across multiple oncology programs. This role partners closely with clinical leadership and cross‑functional study teams to advance high‑quality clinical deliverables, with a strong emphasis on late‑phase execution and NDA‑aligned activities . This is a senior scientific role for candidates with deep oncology expertise, exceptional clinical document authorship skills, and hands‑on experience supporting Phase 2/3 data review, regulatory submissions, and inspection‑readiness.

Key Responsibilities

Clinical & Scientific Leadership

• Serve as the CRS lead for assigned oncology studies, partnering with the clinical lead to drive scientific and medical strategy.
• Develop a thorough understanding of study protocols, endpoints, and requirements to support late‑phase execution.
• Act as a liaison between the medical monitor, clinical operations, and CROs to ensure scientific alignment and study efficiency.

Protocol & Clinical Document Ownership

• Contribute to the development and authorship of protocol synopses, protocols, amendments , and cross‑functional adjudication processes.
• Draft and review Informed Consent Forms (ICFs) and support site‑specific ICF requests.
• Support development and updates of Investigator Brochures (IBs) and other key study documents.

Late‑Phase Data & Safety Review

• Lead routine medical data reviews , including patient‑level listings for data cleaning and aggregate reviews for safety trends, efficacy outcomes, and protocol conduct.
• Collaborate closely with pharmacovigilance and medical directors on SAE review, safety signal assessment, and trend identification .
• Contribute to and review Clinical Study Reports (CSRs) for late‑phase trials.

Regulatory & NDA Submission Support

• Support clinical and safety sections of NDA, sNDA, and MAA submissions, including data summaries, briefing packages, and regulatory responses.
• Participate in audit‑readiness and inspection‑readiness activities.
• Assist in preparing clinical materials for Health Authority interactions .

Cross‑Functional Collaboration

• Partner with Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory Affairs, Translational Sciences, and Project Management to ensure high‑quality, on‑time study deliverables.
• Support creation of CRFs, data review plans, and study‑level review tools.
• Contribute to Investigator Meetings, SIV presentations, and DMC materials.

Leadership & Mentoring

• Provide guidance and mentorship to junior Clinical Scientists.
• Participate in internal process improvement, SOP development, and operational excellence initiatives.

Candidate Profile & Requirements

• Bachelor’s degree in Life Sciences required; advanced degree (MD, PharmD, PhD, MS) strongly preferred.
• 12+ years of clinical research experience within pharma/biotech, including direct oncology development experience.
• Demonstrated experience supporting late‑phase (Phase 2/3) clinical trials , including data review, safety interpretation, and CSR authorship.
• Prior involvement with regulatory submissions (NDA/sNDA/MAA) and Health Authority interaction materials.
• Strong working knowledge of GCP/ICH , oncology study design, statistics, and clinical operations.
• Excellent communication, scientific writing, and cross‑functional collaboration skills.
• Proficiency with EDC platforms (e.g., RAVE) and clinical data review tools.
• Adaptable, proactive, and comfortable working in a dynamic, fast‑moving clinical environment.

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