Title: Contract Director/Sr. Director, Clinical Science (Early Oncology Development)
Location: San Francisco/Boston/Remote
Pay Rate: $95/hour-$150/hour
Job Summary
Our Clinical Development team has an exciting new opportunity for someone to join as a Contract Director/Senior Director, Clinical Science (Early Development). This person will provide scientific and clinical expertise to develop, design, conduct, analyze, and report global clinical trials in accordance with approved clinical development plans and Health Authority (e.g., FDA/EMA, etc.) regulatory requirements.
Key Responsibilities
Contribute to oversight of trials in start-up, conduct, and close-out, for Phase I-III in close coordination with Clinical Operations
Participate in critical site-facing activities (PSVs, SIVs, etc.); contribute to preparation of meeting materials in collaboration with the Clinical Trial Lead.
Coordinate and conduct regular data/safety/efficacy reviews and identify trends across programs in collaboration with the Global Medical Monitor
Contribute to the cross functional trial team as the clinical sciences lead.
Participate with the study team to prepare for and execute regulatory milestones
Contribute to the development of study documents for activities around study conduct (e.g., protocols, IBs, eCRFs, meeting abstracts, manuscripts, RECIST/IWG training materials), regulatory requirements (e.g., briefing documents), and IDMCs (e.g., charters)
Work with statisticians/biometrics to develop the required tables/listings/figures and contribute to the interpretation of efficacy and safety data from clinical trials.
Present safety findings and study status to internal stakeholders (e.g., safety working group/senior management meetings)
Coordinate presentations at IDMC meetings, and other meetings, such as Investigator and Safety Review Meetings
Participate in various initiatives and duties as required by the clinical development program.
Professional Experience/Qualifications
Advanced degree (PharmD, MD, DO, PA, NP, PhD, etc.) in science is required, and 3+ years of experience in clinical research and/or drug development within the pharmaceutical industry.
Prior drug development experience in oncology is preferred
Experience using Medidata EDC and data visualization programs (e.g., R-Shiny, SAS, SpotFire, Tableu, Excel Pivot Tables, etc.) is preferred
Experience in developing relationships with key investigators and KOLs
Knowledge of GCP/ICH, study design, statistics, and basic clinical operations required
Experience writing, editing, and reviewing protocols, informed consent templates, study manuals, conference presentations, and journal publications
Team oriented, goal-driven, organized, and highly collaborative
Excellent written and oral communication skills
Ability to adapt in a fast-paced, agile team environment
No salary data published by company so we estimated salary based on similar jobs related to Non Tech and Non Tech jobs that are similar:
$30,000 — $62,500/year
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