Principal Scientist, Clinical Operations Immunology

Job Description Job Summary

This position provides oversight and leadership of clinical program execution. In this position, you will have the opportunity to lead and direct global, cross-functional teams in end-to-end clinical development activities (strategic planning through post-marketing approval). You will apply project management and organizational leadership expertise in our fast-paced, industry-leading, dynamic bio-pharmaceutical company.

• 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 (e.g., program level overviews; senior management and governance meetings; regulatory agency interactions; advisory meeting preparation). Serves as an escalation point for issues and promotes cross‑function solutions.
• Leads efforts to maximize operational feasibility and efficiency. Ensure consistency and quality across assigned portfolio.
• Serve as the operational representative on the Product Development’s Clinical Subteam.
• Contributes to resource planning and staffing (hiring and/or project onboarding, supervision of clinical scientists and study managers).
• Collaborate and facilitate interactions with key internal and external stakeholders (e.g., KOLs, suppliers) in support of clinical program objectives.
• Assist the Clinical Directors in scientific leadership/investigator initiatives including preparation of publications and meeting presentations.
• May lead and/or implement process improvement and strategic initiatives.
• Manage direct reports including professional development and performance management.

Demonstrated ability to drive and manage clinical program(s) (e.g., strategic planning through post‑approval); this includes the ability to:

• Influence opinions and decisions of internal and external customers/vendors across functional areas and within the division.
• Interact with key stakeholders across department, division, and company. Role requires a proactive approach, strategic thinking, and leadership to envision, plan, and execute organizational goals.
• Make decisions guided by profit plan or budget that impact support, resourcing, and implementation of projects, programs, and/or technologies. Demonstrated ability to effectively delegate work to meet business needs.
• Resolve complex technical, operational, and financial problems. Decisions guided by resource availability and department objectives. Ability to take a broader view of issues to maximize benefit and/or impact to the organization.
• Have a strong understanding of the end-to-end clinical research process.
• Have excellent writing and communication skills.
• Demonstrate leadership skills in supervising people, managing programs & processes, leading meetings, and/or influencing peers and direct reports in a matrix environment.
• Exhibit problem‑solving, conflict resolution, and critical thinking skills.
• Possess expert knowledge of GCP and ICH regulations.
• Demonstrate project management and time‑management/organizational skills.
• Build team capabilities through proactive coaching.
• Provide guidance to team members/colleagues for functional area deliverables with emphasis on consistent application of therapeutic area or program‑specific requirements.
• Show strong communication skills with advanced oral and written English skills.
• Have advanced computer/database skills.

• Bachelor’s degree +12 years of experience in pharmaceutical, clinical drug development, project management, and/or medical field.
• OR master’s degree +9 years of experience in pharmaceutical, clinical drug development, project management, and/or medical field.
• OR PhD/Pharm
  
  D +6 years of experience in pharmaceutical, clinical drug development, project management, and/or medical field.
• Preferred: degree in life sciences.

• Highly preferred: experience leading clinical programs in gastroenterology, dermatology, pulmonary, or rheumatology, especially autoimmune or immune‑mediated disorders.
• Experience leading global clinical programs, including trial initiation through database lock.
• Experience…