Senior Principal Scientist, Clinical Operations - Immunology

Role Summary

This role provides strategic, scientific, and operational leadership for highly complex clinical programs, potentially spanning multiple disease areas and large outcome trials. You will lead global, cross-functional teams in end-to-end clinical development from strategic planning through post-marketing approval, applying project management and organizational leadership in a fast-paced biopharmaceutical environment.

Responsibilities

• Overarching responsibility and oversight of clinical program execution, delivering innovative ideas to achieve objectives.
• Lead and direct teams to support key program planning and execution elements (e.g., program-level overviews; senior management, governance meetings; regulatory agency interactions; advisory meeting preparation). Serve as an escalation point for issues and promote cross-functional solutions.
• Apply expertise 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.
• Contribute to resource planning and staffing (hiring and/or project onboarding; management of clinical scientists and/or study managers; may include management of program leads).
• Collaborate and facilitate interactions with key internal and external stakeholders (e.g., KOLs, suppliers and licensing partners) in support of clinical program objectives.
• Assist the Clinical Directors in scientific leadership/investigator initiatives including preparation of publications, meeting presentations.
• May lead and/or implement process improvement and strategic initiatives.
• May lead operational components of mergers and acquisitions (e.g., due diligence activities, portfolio integrations).
• Manages and provides feedback and developmental opportunities for direct reports and staff.

Qualifications

• Required: Demonstrated ability to drive and manage highly complex clinical programs spanning strategic planning through post-approval; experience representing the company in external partnerships and key strategic engagements; ability to lead across functions.
• Required: Influence opinions and decisions of internal and external customers/vendors across functional areas; proactive approach, strategic thinking, and leadership to envision, plan, and execute organizational goals.
• Required: Decisions guided by budget/resource availability; demonstrated ability to delegate work to meet business needs.
• Required: Resolves complex technical, operational, and financial problems; ability to take a broader view to maximize benefit and impact.
• Required: Advanced understanding of end-to-end clinical research process.
• Required: Excellent writing and communication skills.
• Required: Demonstrated leadership skills, managing people, programs and processes; ability to lead meetings in a matrix environment.
• Required: Advanced problem solving, conflict resolution, and critical thinking skills.
• Required: Expert knowledge of GCP and ICH regulations.
• Required: Demonstrated project management and time management/organizational skills.
• Required: Build team capabilities through proactive coaching.
• Required: Provide guidance to team members/colleagues for deliverables with emphasis on consistent application of therapeutic area or program-specific requirements.
• Required: Strong communication skills with advanced oral and written English.
• Required: Advanced computer/database skills.
• Preferred: Experience with CoPilot, MS Forms, and Power Automate.
• Preferred: Experience managing direct reports.
• Preferred: Experience in autoimmune and/or immune mediated diseases in gastroenterologic, rheumatologic, and dermatologic diseases (e.g., ulcerative colitis, rheumatoid arthritis, psoriasis, atopic dermatitis).
• Preferred: Conducted global phase I–V trials (inclusive).
• Preferred: Experience in regulatory filings (e.g., agency responses, filing documents).

Skills

• Leadership and program management
• Strategic planning and cross-functional collaboration
• Regulatory affairs and compliance (GCP/ICH)
• Scientific writing and communications
• Stakeholder engagement
• Problem solving and critical thinking
• Coaching and team development
• Budget/resource management

Education

• Bachelor’s degree + 15 years OR Master’s + 12 years OR PhD/PharmD + 8 years of pharmaceutical and/or clinical drug development experience.
• Degree in life sciences, preferred.

Additional Requirements

• Travel: 10%