Activity

• Lead the overall development strategy of the product.
• Lead the cross-functional project team to secure approval and funding for the overall product development plan and through the strategic planning and delivery of the development program, proactively identifying and managing issues and risks and ensuring decisions are made at the appropriate levels and with the appropriate cross-functional input.
• Lead cross-functional delivery to the agreed development budget and timeline – collaborating with the cross-functional team members to track and manage issues in budget and timelines and bringing significant variations to R&D management for approval based on agreed trashold
• Report accurate project status and escalate issues whenever they cannot be resolved within the team
• Collaborate with function leads to ensure their teams are fully resourced and skilled appropriately to deliver, working expeditiously to highlight any resource gaps that impact the program delivery or quality. Participate in sub-team leadership.
• Lead quality risk management to ensure significant risks to the programs have planned mitigations and are flagged in terms of likelihood and impact, to the relevant leadership.
• Develop and manage end to end product development plans in Planisware to accurately reflect the tactical plan/timeline and interrelated functional.
• Ensure all relevant documentation is accurate, current, and approved by respective leadership.
• Manage multiple projects, programs or a large portfolio of inter-related projects
• Willingness and ability to travel domestically and abroad as needed (10%).

Education:

• Required: Bachelor’s level degree in scientific field
• Preferred: Advanced scientific degree (M.D., D.O., Ph.D.)

:

• Required: 5 year’s experience in the pharmaceutical industry and at least 3 years leading development projects (Generic/specialty) through to registration and launch
• Solid understanding of drug development (Gx & Specialty), industry guidelines, and regulatory and submissions processes globally
• Experience leading a cross-functional project team through all stages of development
• Established track record of effective and influential oral presentations – including presenting investment opportunities to senior executive teams.
• Preferred: Experience delivering MAA/NDA/BLA/JNDAs as well as sNDAs
• Proven track record of delivery lifecycle management programs

Specialized or Technical Knowledge Licenses, Certifications needed:

• Project Management Professional (PMP®) preferred
• Excellent computer software skills, specifically – Planisware / Microsoft Project, SharePoint, PowerPoint, Word, Excel and Outlook
• Functional Knowledge:
• In-depth knowledge of the drug development process in Specialty

Job-specific Competencies:

• Leadership and Strong Interpersonal and People Skills
• Results and Performance-Driven: Assumes personal ownership and accountability for business results and solutions; consistently delivers results that meet or exceed expectations
• Excellent Communication Skills, both Written and Oral
• Collaboration and Team Work
• Sense of Urgency: Proactively senses and responds to problems and opportunities; works to reduce “cycle” time; takes action when needed.
• Accountability: Should be a results-oriented team player who leads by example, holds him/herself accountable for performance

Director, R&D Project Management Israel, Spec PL Late & Established

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