Responsibilities
- Responsible and accountable for the operational execution of a suite of clinical trials encompassing a clinical program.
- Lead and direct teams to support key program planning and execution elements.
- Serve as an escalation point for issues and promote cross‑function solutions.
- Lead efforts to maximize operational feasibility and efficiency.
- Ensure consistency and quality across the assigned portfolio.
- Serve as the operational representative on the Product Development’s Clinical Subteam.
- Contribute to resource planning and staffing.
- Collaborate and facilitate interactions with key internal and external stakeholders.
- Assist the Clinical Directors in scientific leadership/investigator initiatives.
- May lead and/or implement process improvement and strategic initiatives.
- Manage direct reports, including professional development and performance management.
Requirements
- Bachelor’s degree + 12 years OR Master’s + 9 years OR PhD/PharmD + 6 years
- Pharmaceutical and/or clinical drug development experience
- Degree in life sciences, preferred.
- Experience in conducting global clinical trials programs, including product planning through initial filing in Gastroenterology, Dermatology, or Rheumatology, especially autoimmune or immune‑mediated disorders
- Managing direct reports
- Experience in conducting clinical trials in gastrointestinal, preferably autoimmune and/or immune mediated disease trials.
- Experience with selecting and utilizing programmatic vendors
- Experience in developing protocols and study related documents for Immunology related clinical trials
Core Competencies
Demonstrates extensive experience in managing clinical trials, particularly in Gastroenterology, Dermatology, and Rheumatology, with a focus on autoimmune and immune‑mediated disorders. Proven ability to lead teams, ensure operational efficiency, and develop protocols for Immunology‑related clinical trials.
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