About this role
Premier Research is looking for a Associate Project Director (Immunology, Rheumatology, Dermatology) to join our General Medicine team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here. What You'll Be Doing: Act as primary liaison between Premier Research and the customer, chairing project team meetings; work strategically with clients to ensure understanding of study and corporate objectives, ensuring team alignment on timelines, milestones, and objectives Ensure cross functional management and coordination of the project team, including Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and project delivery per client goals and Premier Research requirements Ensure high quality project plans align with client study and corporate objectives; maintain and update study plans; manage quality, risk, and contingency planning throughout the study; monitor deliverable quality and address issues with appropriate team members; oversee documentation to keep Trial Master Files audit ready; support audits and respond to audit reports Ensure adherence to project budget and scope to realize profitability; review/approve expenses and address contractual and budgeting issues; provide accurate information for timely invoicing and forecasting; identify scope changes and secure Change Orders; prepare staff utilization forecasts for the study Manage and resolve project related conflicts with corrective/preventative actions, alerting senior management to potential issues; review and recommend adequate resources to meet deliverables and milestones; ensure transition planning and communication for staff changes; identify, recruit, and manage central vendors as required Assist Business Development, including leading proposal presentations with Business Development and Scientific Account Leadership; facilitate team training (therapeutic, protocol specific, process); provide performance feedback for annual appraisals; mentor junior staff (Associate Project Managers, Project Specialists) and less experienced PMs in Business Development activities May travel up to 25% What We Are Looking For: Bachelor's degree, or international equivalent from an accredited institution, preferably in a clinical, biological, or science-related field 8-14 years trial management experience in a pharmaceutical company/medical device company/CRO, including 5-8 years' experience serving in a Project Leader role Advanced budget/finance/costing experience on both a project and portfolio level; experience in coaching/mentoring other PMs Strong experience managing complex trials, multiple phases, and full lifecycle, with global project management experience; experience presenting at bid defenses and investigator meetings Expert knowledge of ICH/GCP regulations; advanced working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures; expert knowledge of project management principles and the clinical development process In depth therapeutic area and protocol knowledge required in Immunology, Rheumatology, or Dermatology Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status