Job Overview :
The Associate Director's function is to oversee and direct multiple project concurrently and / or programs, or mega studies as assigned globally.
Responsibilities typically include developing study strategy and costing in cooperation with other departments and the PMO.
Additionally Project Directors develop and manage project teams, guide team communications, risk, scope, schedule, cost, quality and stakeholder management to effectively ensure plans are proactively and effectively executed to meet client expectations.
The Project Director is expected to have an extensive working knowledge of drug development and clinical trial execution they supervise and assess the performance of the core team members and direct efficient and effective day-to-day operations, while maintaining good relationships with sponsors.
They may serve as lead of business development opportunities and may line management staff as assigned.
Essential Job Duties
Lead core project team(s) and facilitate team's ability to lead extended / complete project team
Responsible for provision of client deliverables on-time, within budget and scope and with required quality for assigned projects or program
Develops strategies to control and improve financial margin and minimize write-offs across projects and / or programs while maintaining quality
Proactively identify out of scope activities, execute necessary change orders and support negotiations with client on project budget issues
Accountable for budget across assigned projects and / or programs
Responsible for mitigate plans where variance occurs in execution of deliverables to plan
Structures work and organization effectively and efficiently
Grows people within and across the organization
Puts people into roles which maximize their contribution and organizational effectiveness
Develops deep leadership bench beneath oneself
Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services
Effectively and proactively resolve conflicts as needed
Demands high performance on all strategy initiatives
Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects or programs
Ensure that all staff allocated to assigned projects or programs adhere to professional standards and SOPs
Provide performance feedback on team members to respective functional line management
Monitor team performance and facilitate adjustments when necessary to ensure goal attainment
Present at external and / or internal meetings
Define and manage project or program resource needs and establish succession plans for key resources
Support business unit utilization targets
Implement and monitor progress against project plans and empower team to revise as necessary
Responsible for appropriate issue escalation via CAIR and CAPA processes
Serve as key client contact for assigned projects
Establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business
Turn ideas into processes and / or sales which drive growth
Prepare and deliver presentations for new business in collaboration with business development
Prepare and actively participate as operational lead in internal Project Review meetings
Contribute to proposal strategy , development, costing and bid defense for assigned business development opportunities
Able to discuss global strategic options and study execution challenges / opportunities with the client during the proposal development / bid defense
Delivers visible leadership with clients through effective problem solving and generation of customer solutions.
Find creative and cost-effective ways to meet quality metrics agreed with client and key stakeholders
Use experience from past projects and lessons learned to adapt and implement quality improvements across projects currently being managed
Ensure project, risks are discussed at project reviews. Monitor and control the risk plan and provide ongoing oversight to ensure mitigation plans are in place and working.
Escalate risks newly identified by the project team to stakeholders
May be assigned line management responsibilities for the recruitment, training, utilization, development and performance reviews of assigned staff.
In the absence of line management responsibilities, the Project Director will be expected to mentor project management staff.
Develop and manage client project metrics
Perform other duties as assigned by management
Assist in the implementation of study training plans. Function as the trainer where appropriate.
Education / Qualifications :
University / College degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution
Detailed knowledge of financial control procedures (e.g. costing systems, TAQ / EVA)
Thorough knowledge of project management processes
Thorough knowledge of time and cost estimate development
Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
Broad knowledge of drug development process and client needs
Bilingual (Mandarin speaking due to business needs)
Location : Asia (preferably Singapore, Taiwan)
business proficiency in Mandarin is required in order to liaise with Mandarin speaking counter parties / clients
Minimum of nine (9)years relevant clinical research experience in a pharmaceutical company / CRO including at least four (4) years of full project management responsibility.
In lieu of the above requirement, candidates with >
six(6) years supervisory experience in a health care setting and >
seven (7) years clinical research experience including four(4) years of international project management experience in the pharmaceutical or CRO industries will be considered
Experience in managing global programs with large financial value and complicated structure, multiple vendors and / or sub-CROs and Academic Research Organizations in a virtual environment