Associate Project Director, Neuroscience - Remote

Project Management United States


Description

Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for an exceptional Associate Project Director to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.

At Premier Research, we are science-minded and heart-centered. Join us.

The Associate Project Director (APD) is a highly skilled, top performing expert in the business of developing new drugs, as well as managing projects. The APD is the expert on the critical aspects of the study and is responsible for overall project delivery, customer satisfaction, risk mitigation planning, escalation and resolution, budget management, and high quality results that align with the customer’s goals. This role leads, plans, organizes, and directs all activities related to the execution of complex and/or international clinical trials/projects and may lead small, non-complex programs. The APD provides customer-focused leadership, leads by example, supports less experienced Project Managers (PM) to allow them to develop, and provides continued guidance to less experienced members of the PM/TDPM team. Act as the primary liaison between Premier Research and the customer for all assigned projects and chair project team meetings and teleconferences 

· Appropriately balance tactical (triple constrains) and strategic (customer satisfaction, team development) project consideration 

· Augment tactical skills with the ability to think and act strategically

· Work strategically with clients, to ensure full understanding of current and future study and corporate objectives  and communicate to the project team  to ensure engagement and understanding of the importance of study timelines, milestones and objectives so project deliverables are properly aligned

· Ensure successful cross functional management and coordination of efforts assigned to all members of the project team, including but not limited to Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall project delivery according to client goals and Premier Research requirements

· Ensure high quality project plans are developed in line with the study and corporate objectives of the client. Responsible for adherence to and as necessary updating study plans.

Manage quality, risk management, proactive contingency planning and execution throughout the study

· Provide the client analyses of the current competitive market place and on competing research activity to support the client in their decision making

· Ensure adherence to project budget and scope of work to realize project profitability

· Ensure all project tasks are completed in accordance with project plans and in compliance with standard Premier Research processes, policies, and procedures

 Ensure effective communication is maintained and project status reports including performance against contract, customer expectations, and project baselines and monthly progress reports are provided both internally and externally

· Continually review and make recommendations to ensure adequate resources are available to meet project deliverables and milestones;

Ensure appropriate transition planning and stakeholder communication for any change in staff

· Manage and resolve issues; Facilitate resolution of project related conflicts with necessary corrective and preventative actions and alert senior management to potential issues

· Monitor the quality of project deliverables and address quality issues with the appropriate team members; oversee project documentation, ensuring Trial Master Files are completed by the functional groups and remain audit ready

· Support study audits and respond to audit reports

 Facilitate team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training

· Assist in Business Development activities, including leading proposal presentations in partnership with Business Development and Scientific Account

· Prepare forecasts for staff utilization over the life of the study

· Review and approve project expenses and ensure all study related contractual and budgeting issues are addressed

· Provide accurate information to ensure timely invoicing and allow for accurate forecasting

· Identify scope of work changes across all functional areas and secure Change Orders

· Provide performance feedback on project team members for annual appraisals

· Mentor and train junior level staff (i.e. Associate Project Managers, Project Specialists);

· Mentor less experienced PMs in Business Development activities and support them on an ongoing basis

· Identify, recruit and manage central vendors as required per project scope


You'll Need:
  • 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
  • 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 CNS trials, multiple phases, and full lifecycle
  • May travel up to 25%