Principal Scientist, Clinical Operations Immunology Full-time

Clinical Program Leader

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.

Job 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 (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.
• 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, supplies) 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.
• Management of direct reports including professional development and performance management

Core Skills

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 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 strong understanding of end-to-end clinical research process
• Excellent writing and communication skills
• Demonstrated leadership skills in supervising people, managing programs & processes, leading meetings and/or influencing peers and direct reports in a matrix environment
• 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

Education/Experience

• Bachelor's Degree +12 years of pharmaceutical, clinical drug development, project management, and/or medical field experience
• OR master's degree +9 year of pharmaceutical, clinical drug development, project management, and/or medical field experience
• OR PhD/PharmD Degree +6 year of pharmaceutical, clinical drug development, project management, and/or medical field experience
• Degree in life sciences, preferred.

Ideal Candidate Would Have:

• Highly Preferred: experience in leading clinical programs for Gastroenterology, Dermatology, Pulmonary or Rheumatology, especially autoimmune or immune-mediated disorders.
• Experience in leading global clinical programs, including trial initiation through database lock.
• Experience in developing protocols and study related documents for Immunology related clinical trials.