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 

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.

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