Director, Project Management - FSP (Client Embeded) - Remote based in the US

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Position requires extensive Oncology global full service clinical trial management experience. Preference given to candidates who also have Cell/Gene Therapy experience. Please demonstrate these in your application to be considered.

Join Us as a Project Manager Director – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Project Manager Director, you will serve as the Project Lead and primary sponsor contact. You will oversee the overall delivery of the project (quality, time, cost) on behalf of the organization. You will establish and communicate customer expectations to the project team with minimal direction, serve as a point of escalation, and ensure pathways are adhered to internally and externally. You will lead the cross-functional project team to meet or exceed deliverables, managing projects of increasing complexity (such as multi-service, multi-region/country, therapeutic complexity, financial scope).

What You’ll Do:

• Serves as the primary contact and subject matter expert between the sponsor and the organization at the project level.

• On projects where the scope requires, ensures clear delineation in responsibilities and communication pathways for secondary project leads (such as lead in a specific region, lead for a specific vendor(s) or subset of delivery).

• Drives and owns the strategic direction and overall delivery of the cross-functional project (time, cost, quality).

• Oversees the financial stewardship at a project level by demonstrating an intimate understanding of the contract, resource alignment to budget, management of Out of Scope activity, drive the Con Mod process/negotiations and team execution to timelines.

• Drives business by ensuring management of customer expectations to achieve optimal delivery during the project.

• Drives Risk Identification and Issue Resolution at project level (RBQM/RESOLVE).

• Ensures project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements.

Education and Experience Requirements:

• Bachelor's degree or equivalent; preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years).

• Proven clinical expertise in Oncology

• Regulatory submission experience

• Program management experience

• Strong leadership skills

Preferred Qualifications:

• Cell Therapy study management experience, preferably in a pharma/biotech setting

• Project management certification 

• Knowledge of process improvement methodology such as Lean Sigma/Change Management, certification is desirable but not mandatory

• Experience with development and implementation of digital health initiatives in clinical studies

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables

• Advanced, broad understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC, publishing, etc.

• Advanced understanding of medical terminology, statistical concepts, and guidelines

• Sharp analytical, investigative, and problem-solving skills

• Advanced financial acumen with an in-depth of knowledge and practical application of budgeting, forecasting and resource management

• Recognized executive presence and consultation and presentation skills

• Effective critical and strategic thinking skills that accounts for a broad impact

• Exce