Associate Director, Study Manager, Immunology

Location: North Wales

Job Description This position participates in the strategy and leads the operational planning and execution of one or more clinical trials in our Tulisokibart program. In this position, you will have the opportunity to demonstrate your advanced leadership and technical skills as part of a global, cross-functional team. You will build and coach your team in the development of project management, communication, and collaboration skills in support of our clinical trials.

Job Responsibilities Responsible for the operational planning, feasibility, execution and conduct of clinical trial(s)
Serves as the Clinical Trial Team lead Leads and directs teams in key study planning, development, and execution elements (e.g. operational reviews, issue escalation/mitigations, presentations at Sr Management meetings, program level cross functional meetings and governance)
Responsible for facilitating and collaborating with key internal/external stakeholders (study team, subsidiary country teams, vendors, committees, etc.) in support of clinical trial objectives

Liaises with partners, vendors, and vendor management team Review and provide clinical operations input into relevant clinical documents such as the protocol and other documents as appropriate

May serve as a subject matter expert and/or participate on process improvement teams

Builds talent and capabilities of junior team members through proactive coaching, mentoring and development opportunities

May include management of direct/ indirect reports including assignment of resources, professional development, and performance management

Core Skills Demonstrated ability to drive and manage scientific activities on clinical protocols

This position may represent the company through external partnerships, collaborations, and key strategic engagements

Strong knowledge of clinical research regulatory requirements (e.g., Good Clinical Practice (GCP) and International Council for Harmonisation (ICH))Proven ability to manage competing priorities and effectively delegate and assign activities to meet the business needs

Ability to develop short and mid-range project plans that are realistic and effective at meeting goals

Strong analytical skills to drive operational milestones

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. Roles requires a proactive approach, strategic thinking and leadership driving toward study goals

Demonstrated leadership skills in programs & processes, leading meetings and influencing peers and direct/indirect reports in a matrix environment

Problem solving, prioritization, conflict resolution, and critical thinking skills

Strong communication, writing, and presentation skills

Proficient knowledge in Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc.)Education/Experience Bachelor's Degree and 9+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience
-OR-Master's Degree and 6+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience
-OR-PhD/PharmD Degree and 2+ years 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 conducting clinical trials for Gastroenterology, Dermatology or Rheumatology,  especially autoimmune or immune-mediated disorders

Experience in conducting global clinical trials, including trial initiation through database lock Experience in managing and driving operational activities on protocols for immunology related clinical trialsclinicaltrialjobs

Required Skills:

Adaptability, Analytical Problem Solving, Clinical Development, Clinical Operations, Clinical Sciences, Conflict Management, Critical Thinking, Ethical Standards, Good Clinical Practice (GCP), Partner Relationship Management (PRM), People Management, Presentation Delivery, Process Improvements, Stakeholder Alignment, Strategic Thinking Preferred

Skills:

Leadership, Prioritization, Problem Solving, Study Management, Vendor Management Current Employees apply HERE Current Contingent Workers apply HEREUS and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the…