Senior Clinical Scientist

Role Overview

• Participates in development of the Clinical Development plans (CDPs)
• Supports the assigned Medical Director/Clinical Science Physician(s) with various deliverables necessary for effective and efficient CS plan execution for the assigned assets/indication(s).
• Has primary responsibilities for supporting Medical Directors/Clinical Science Physicians with clinical documentation.
• Represents Clinical Science on various teams/sub-teams or other appropriate forums.
• Supports training of study site personnel.
• Expected to perform their responsibilities with independence and are likely to have external interactions with cooperative groups, key opinion leaders (KOLs), external vendors supporting the work of Clinical Science.
• Supports the design and writing of clinical protocols and associated clinical study documents (e.g., ICFs, charters, operational manuals, etc.)
• Serves as an expert on the clinical study design (including trial procedures and requirements) and develops training materials to ensure quality execution by the investigational sites.
• Supports cross-functional teams with study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures.
• Provides medical monitoring support or oversight of activities conducted by a CRO.
• Collaborates on, or lead where appropriate, the writing of clinical sections of key program documents including Investigational New Drug submissions, Investigator Brochures, Clinical Study Reports, and other global regulatory submissions and responses.
• Supports clinical development planning by participating in the evaluation of innovative trial designs.

Requirements

• MD, PhD, or PharmD with oncology experience required.
• Cell Therapy experience preferred.
• 6+ years of experience in a clinical research-related role. 3-5 years' experience in a Clinical science/development role preferred.
• Proficient knowledge of GCP/ICH, drug development process, study design, statistics, understanding of functional and cross-functional relationships
• Proficient knowledge and skills to support program specific data review, trend identification, data interpretation, data cleaning
• Experience with Spotfire and/or other data exploration tools preferred
• Knowledge of Non-Small Cell Lung Cancer therapies preferred
• Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
• Previous experience working with CROs and other vendors/suppliers preferred
• Previous experience with Phase I-III US and Global/Ex-US clinical trials preferred
• Data listing review experience required
• Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature
• Experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
• Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel)
• Good business acumen; has working knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g. clinical operations, biostatistics, regulatory, commercial operations, etc.
• Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment
• Good interpersonal, verbal communication and influencing skills; can influence without authority
• Strong written communication skills
• Good business presentation skills; is comfortable and effective when presenting to others, internally or externally
• Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy
• Ability to travel (~10%)

Tech Stack

• Google Cloud Platform

Benefits

• Health insurance
• Retirement plans
• Paid time off
• Flexible work arrangements
• Professional development