Sr Project Manager, Drug Development, Pharmaceuticals
GForce Life Sciences, RALEIGH NC
Our client, a global pharmaceuticals manufacturer has engaged GForce Life Sciences to identify a hands-on project manager to lead phase I-III drug development projects. This is an exciting time to join this firm as they are deeply entrenched in delivering world class drugs to the marketplace to assist in unmet therapies.
Duties / Expectations of Role
- Project management leadership for cross functional teams (eg: PVRM, Regulatory, Medical Monitoring, Clinical and Program Finance, Clinical Operations, etc.).
- Manage therapeutic areas’ clinical projects by overseeing the initiating, planning, execution, and closeout of the clinical development plans for clinical programs.
- Facilitate strategic planning for operational plans with CDRA and external partners as appropriate.
- Work closely with the Therapeutic Area Head (TAH), Development Program Operations, TA Operations Lead, Clinical Trial Management (CTM) Operations Lead and Program Director to ensure clinical study deliverables support clinical program goals and project execution
- Works closely with the TAH, DPO and CTM Operations Lead to ensure the required deliverables are aligned with meeting the review committee objectives
- Facilitate quarterly and annual resource forecasting across all functional areas
- Lead timeline and cost estimates development for clinical program lifecycle management
- Assess and monitor the variance from plan across functional areas to determine any impact on the clinical development plan (CDP)
- Responsible for analysis of Key Performance Indicators (KPI) and developing appropriate action plans
- Coordinate risk analysis and contingency planning for clinical programs
- Facilitate Clinical Development Sub-Team comprised of cross functional team representatives from CDRA, including but not limited to Clinical Sciences (early and late phase), Medical Writing, Clinical Trial Management, Biostatistics, Data Management, and Regulatory Affairs
- Serves as an escalation point for CDST members and coordinates and leads the cross functional resolution regarding issues potentially impacting clinical program objectives and deliverables, timelines, budgets and quality
- Provide clinical program updates to management on an as needed basis
- Serve as clinical project management liaison on collaboration teams with external partners
- Manage the development and adherence to key regulatory submission timelines and communication plans for global submissions
- Responsible for overall project timeline close-out
- Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight
- Initiate and participates in strategic initiatives within the CDRA organization
- Contribute to the creating and revision of functional Standard Operating Procedures (SOPs) and Guideline documents
- BS degree and minimum of 10+ years relevant industry experience.
- 7 years relevant FDA regulated industry experience preferably with drug development; at least 4 of which are in project management
- Strong interpersonal & leadership skills
- Ability to provide strategic direction and guidance to teams aligned with clinical development plans
- Anticipates new trends in a competitive landscape and therapeutic areas to guide the organizational strategy
- Provides a comprehensive industry perspective for project management execution
- Strong analytical skills with a data driven approach to planning, executing, and problem solving
- Effective communication skills to all levels of the organization
- Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
- Accomplished influencing and negotiation skills
- Proficient in creating and maintaining clinical program budgets and timelines
- Exceptional project management, cross-functional team leadership, and organizational skills
- Ability to build successful and effective teams and collaborations internally as well as with external partners
- Referenceable examples of ability to deliver innovative solutions to problems that have been present
- Experience with ICH & GCP
- Exceptional time schedule and scope management competence
- MS or BS scientific disciplines and pharmaceutical or related work experience in field.
- Masters or doctoral level (PhD, PharmD, MD, MBA); undergraduate technical/scientific degree
- GMP & GLP experience
- Project Management Professional (PMP)®
- This is a 12+ month contract role (full time, long term consulting)
- On site in Cambridge, MA