Senior Principal Scientist, Clinical Operations - Immunology

Job Description Job Summary

This position provides expert strategic, scientific, and operational leadership in the planning and execution of highly complex program(s) (e.g., spanning multiple disease areas/indications, involving large outcome trials). 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.

• Overarching responsibility and oversight of clinical program execution, providing innovative ideas to achieve organizational objectives.
• Lead and direct teams to support key program planning and execution elements (e.g., program level overviews; sr. management, and governance meetings; regulatory agency interactions; advisory meeting preparation). Serves as an escalation point for issues and promotes cross-function 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.
• Contributes 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.

Demonstrated ability to drive and manage highly complex clinical program(s) (e.g., strategic planning through post-approval). This position may represent the company through external partnerships, collaborations, and key strategic engagements. 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 proactive approach, strategic thinking, and leadership to envision, plan and execute organizational goals
• Makes 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 the business needs
• Resolves 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
• Has advanced understanding of end-to-end clinical research process
• Excellent writing and communication skills
• Demonstrated leadership skills in managing people, programs & processes, leading meetings and influencing peers and direct reports in a matrix environment
• Advanced problem solving, conflict resolution, and critical thinking skills
• Expert knowledge of GCP and ICH regulations
• Demonstrated 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
• Strong communication skills with advanced oral and written English skills
• Advanced computer/database skills

• Experience managing direct reports
• Experience in conducting autoimmune and/or immune mediated diseases in gastroenterologic, rheumatologic and dermatologic diseases including but not limited to ulcerative colitis, rheumatoid arthritis, psoriasis, atopic dermatitis, etc.
• Conducted global…