Director Therapeutic Area Project Management, ECD

Summary

The TAPM - Early Clinical Development provides project management leadership for the cross-functional CDRA teams (eg: PVRM, Regulatory, Medical Monitoring, Clinical and Program Finance, Clinical Operations, etc.). Manages therapeutic areas clinical projects by overseeing the initiating, planning, execution, and closeout of the clinical development plans for clinical programs. Facilitates strategic planning for operational plans with CDRA and external partners as appropriate.

Responsibilities

• Works closely with the Therapeutic Area Head (TAH), Development Program Operations (DPO), TA Operations Lead, Clinical Trial Management (CTM) Operations Lead and Program Direction 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 CDRA functional areas
• Leads timeline and cost estimates developed for clinical program lifecycle management
• Assess and monitor the variance from plan across CDRA functional areas to determine any impact on the clinical development plan (CDP)
• Drive Clinical Study Concept (CSC) completion
• Works with Clinical Finance, Medical Director, CTM Operations to create an estimate for CSCs as well as Blue Sheet Budgets (BSB) from Protocols
• Work with Medical Director and CTM Operations to create a timeline estimate for CSCs as well as vetted timelines at the time of CSC approval
• Responsible for analysis of Key Performance Indicators (KPI) and developing appropriate action plans
• Coordinate risk analysis and contingency planning for clinical programs
• Facilitates Clinical Development Sub-Team (CDST) 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
• Provides clinical program updates to management on an as-needed basis
• Serves as clinical project management liaison on collaboration teams with external partners
• Manages the development and adherence to key regulatory submission timelines and communication plans for global submissions
• Responsible for overall project timeline close-out
• Lead and participate in the debrief and lessons learned exercises
• Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight
• Initiates and participates in strategic initiatives within the CDRA organization
• Contributes to the creating and revision of functional Standard Operating Procedures (SOPs) and Guideline documents

Experience And Required Skills :

Requirements:
 

• 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

• Line management experience with demonstrated mentoring and coaching skills

• In-depth knowledge of GCP and ICH

Education:

• Masters or doctoral level (PhD, PharmD, MD, MBA); undergraduate technical/scientific degree

Experience

• 15 years relevant FDA regulated industry experience preferably with drug development; at least ten of which are in project management

Certifications

• Project Management Professional (PMP)® - preferred

• NIH certification on the Protection of Human Research Subjects - preferred

Our Client is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, their unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in their own laboratories. Their medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neuromuscular diseases, infectious diseases and rare diseases.