The Judge Group

Sr. Manager/AD Clinical Research (1059642)

The Judge Group South San Francisco, CA

Location: South San Francisco, CA, USA

Salary: $140,000.00 USD Annually - $180,000.00 USD Annually

Description: Our client is currently seeking a Sr. Manager/AD Clinical Research

The individual drives the clinical development strategies for investigational products by leading protocol design, analyzing clinical trial data, and guiding study execution. They develop strong relationships with principal investigators (PIs) and key opinion leaders (KOLs) and stay informed on emerging science and regulatory issues. With expertise in clinical trials, they ensure compliance with Good Clinical Practice (GCP) and provide clinical training for stakeholders. This role involves collaborating across departments, leading data reviews, and participating in site interactions, requiring a detail-oriented, proactive approach and strong leadership in a fast-paced environment.

This Job Will Have The Following Responsibilities

  • Responsible for driving clinical development strategies and execution of assigned investigational products.
  • Develops the study protocol synopsis, leads the analysis of benefit/risk for clinical development protocols and the final study protocol validation and protocol amendments; supports the clinical operations team during feasibility and study execution.
  • Identifies and builds relationships with principal investigators (PI) and key opinion leaders (KOL) in drug development. Seeks out external resources to gain perspective on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs.
  • Develop in-depth knowledge of etiology, natural history, diagnosis, and treatment of disorders. Holds strong expertise in the disease areas by attending scientific conferences and ongoing review of the literature.
  • Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape.
  • Leads data review of trial data, including eligibility review; ensures continuous real-time review of aggregated data during clinical trial conduct.
  • Supports clinical trials and participates in site interactions and education (specific disease areas, drug mechanisms of action, protocol requirements, safety management guidelines, etc.). Provides clinical training for internal stakeholders and clinical trial sites.

Qualifications & Requirements

  • A bachelor’s degree in a related scientific field is required; an advanced degree is preferred.
  • Minimum of 3 years of clinical research experience in psychiatry; minimum of 3 years of industry experience in drug development or biomedical research experience in academia.
  • Expertise in clinical trials: a working understanding of statistical principles, demonstrated ability to perform literature research, analyze and author clinical trial publications; thorough knowledge of the whole processes of clinical trials, clinical research concepts, practices, and GCP and ICH Guidelines.

Contact: arawat@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com
  • Seniority level

    Director
  • Employment type

    Full-time
  • Job function

    Research, Analyst, and Information Technology
  • Industries

    Staffing and Recruiting

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