Clinical Project Director

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment/

The Project Director (PD) for Oncology, CNS, or Cell and Gene Therapy Trials is responsible for overseeing and managing all aspects of the clinical study trials. This role plays a pivotal part in ensuring the successful execution of trials, from initial planning through to completion, with a focus on safety, regulatory compliance, and efficient project management.

This is a full-time, direct hire opportunity for an experienced PD residing in the US. Ideal candidates should have a strong background in PM serving as a SME with Oncology, CNS, or Cell and Gene Therapy clinical trial experience.

Location: United States (Hybrid or Remote)

Responsibilities:

Project oversight:

• Responsible for overall quality and management of the delivery clinical trial projects and programs
• Manages complex, cross-functional resource requirements in line with budgeted, time, scope, and quality expectations for project delivery
• Oversees budgets and ensuring correct financial forecasting, planning, invoicing and timely implementation of out of scope activities
• Reviews and approves content and costing of proposals
• Ensures effective risk management across the project delivery lifecycle
• Negotiates and influences internal and external team members in a professional manner and with successful outcomes
• Effectively solves problems with projects teams by applying strategic thinking and conflict resolution skills
• Balances multiple competing priorities, with effective and efficient resource utilization across projects and programs

Client management:

• Serves as key contact for assigned clients on delivery of scope, customer satisfaction on services and capabilities and the assessment of client needs

Leadership:

• Shows knowledge of and insight into general business principles and practices, and is able to balance business priorities
• Demonstrates a growth mindset, and approaches complex challenges with creativity and flexibility
• Leads by example and encourages team members to develop strong solutions for clinical trial delivery
• Supports the recruitment and interviewing of new employees
• Responsible for supervision of project staff and communication with functional managers, including performance feedback
• 10% of Business travel is required for this position, including possible international travel

Requirements

Qualifications

• Minimum Bachelor’s degree in life science, healthcare and/or business degree; Master’s degree or greater preferred
• Minimum 7 years of relevant work experience
• Minimum 7 years of experience in drug development and/or clinical research
• Extensive clinical project management experience, with at least 5 years of clinical project management experience
• Preference for candidates with CRA experience
• Expert knowledge of ICH-GCP(R2), data and patient privacy practices, and applicable (local) regulatory requirements
• Strong financial acumen, administrative excellence and analytical skills
• Experience managing global clinical trials

Skills

• Excellent written and verbal communication, planning, critical thinking and organizational skills, including command of English language
• Proficiency with various applications including but not limited to Microsoft Word, Excel, and PowerPoint required
• Clinical trial delivery process expertise
• Strong general administrative skills and experience
• Outgoing and client focused
• Proactive and solution oriented
• Strong presentation and networking capabilities
• Experience applying a data driven approach to drive clinical trial delivery solutions
• Able to balance and prioritize competing projects, programs and initiatives, and take action quickly to address urgent needs
• Fosters learning and the advancement and development of others
• Strong presentation skills
• Demonstrated ability to maintain effectiveness in a changing environment
• Willing to take ownership and drive positive results across project and program teams
• Able to work in a fast-paced, challenging environment with a growing company