PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same world-class talent in ALL engagement models. Extraordinarily trained, rigorously supported and technologically empowered to help customers handle capacity and set programs up for success.

Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.

We are seeking anAssociate Director, Project Managementin our FSP division.

The AD partners with a Project Leader or Medical Lead and Clinical Operations Lead co-chairs to pro-actively handle end-to-end development programs (from pre-clinical to commercial), supporting the Project Team to identify and mitigate risk, facilitate issue identification and resolution, contingency plan, and ensure decisions are documented and communicated appropriately. The AD is responsible for creating and maintaining integrated development plans, timelines and budget for the program, as well as tracking and reporting progress

• Partners with Project Team members to create a fully integrated strategic and operational plan aligned with the program strategy and company vision and that anticipates and mitigates risks
• Supports with scenario planning and tracking and mitigating risks to program plans
• Tracks activities to ensure project execution consistent with the integrated development plan, to budget, scope and timing; maintains documents to track and report on progress to management and relevant stakeholders
• With the Project Leader or Medical Lead and Clinical Operations Lead co-chairs, represents the Project Team at governance meetings
• Directs preparation of presentation materials with the Project Team
• Documents meeting discussion and outcomes with clear and concise minutes
• Ensures outcomes are clearly communicated to stakeholders
• Ensures timely, open and effective communication of emerging information and decisions to all relevant stakeholders, including team members, collaborators, functional managers and partners
• Handles Project Team meetings and ad hoc meetings, including
• Agenda preparation
• Minute-taking
• Communication of decisions
• Tracking and resolution of action items
• May provide PM support for the planning and preparation of documents to a quality standard required for Regulatory/Health Authority submissions
• Ensures operational excellence in all processes in support of the business
• Contributes to creation and management of templates, trackers, and business process documents
  

Education

• Advanced degree (Master or PhD) in a health related discipline or equal by experience;
  

• At least 10 years of drug development experience in different phases of development, in different disease areas
• At least 8 years of Project Management experience in a Pharmaceutical or Biotech environment
  

• Strong leadership skills;
• Strong communication and collaboration skills;
• Strong interpersonal skills;
• Strong project management skills (PMP certification is an advantage);
• Ability to respond positively to continuous change and to bring creative solutions to challenges; Comprehensive therapeutic area knowledge, clinical development guidelines and directives and regulatory guidelines
• Expert knowledge of the key principles of cross functional project management (Time, Quality, Cost)
• Excellent oral and written communication and presentation skills
• Technical and systems competency, such as computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems (CTMS, Preclarus, Clarity)
• Proven flexibility and ability to effectively prioritize workload and resources for project team members in a frequently changing environment
• Skilled in process improvement and strategic development, especially as it applies to clinical trials, clinical development and project management
• Ability to coach, mentor and lead global and/or cross-functional teams with a cultural awareness
• Strong financial acumen with an in-depth of knowledge and practical application of budgeting, forecasting and resource management
• Excellent customer service and relationship building skills with the ability to proactively address and prioritize expectations
• Strong executive presence and business acumen
• Advanced negotiation and marketing skills with ability to influence others and drive results
• Proactive, solutions oriented and skilled at risk management
• Excellent judgment, decision making and problem-solving skills and proven track record to apply critical and analytical strategic thinking skills to manage complex/ambiguous situations
• Ability to drive corporate strategies to capture, engage and retain repeat customers