Director, Development Strategic Operations

Arbeitsbeschreibung

As the Director of Development Strategic Operations, you will establish best practice infrastructure, processes and systems for effective management of Development programs and initiatives and their associated resources. You will be accountable to the accuracy of the critical path timelines for multiple studies within a product and accurate representation of the development deliverables including clinical demand and study strategic milestones reporting. Interaction with cross-functional development project teams will be required. You may also lead short term high-value company projects using project management methodology to ensure adequate planning, effective scope management, on time delivery and finally to close the project with lessons learned and appropriate team recognition.

We work in an environment that requires leaders to demonstrate excellence in the ability to develop trust within teams, ensure respect of all team members, drive decisions through accountability, and ensure effective change management. This is a high-impact role integral to the success of the company and will require effective partnerships with the Clinical Development, Manufacturing, Regulatory, Program Management, Research, and Finance. The position will report to the Executive Director of Development Strategic Operations.

Responsibilities include but are not limited to:

• Establishing, implementing and maintaining processes and infrastructure for clinical studies project planning known as the Development Strategic Operations Project Management Office.
• Collaborates with Finance, Program Management, Study Teams, Clinical Supply Chain and Logistics Coordinators to determine 12 week, 36 month, and 10 year horizon plan for various uses including financial planning and manufacturing supply planning.
• Partners with Program Management and Finance to ensure consistent and accurate reporting of clinical study milestones
• Coordinates the collection, development, dissemination and review of Development monthly metrics and standard reports
• Provides mentorship and career development to Development Strategic Operations staff who are responsible for the determining and maintaining accurate study timelines for assigned studies.
• Organizes and manages internal department meetings as required to ensure effective and appropriate documentation of decisions
• Attends leadership meetings as needed to represent Development Strategic Operations.
• Other duties as assigned.

Basic Qualifications

• BS/BA in nursing, science or health related field w/12 years clinical trial management experience –OR-
• MS/MA in nursing, science or health related field w/10 years clinical trial management experience

Preferred Qualifications

• At least 15 years of related oncology clinical trial management experience. Highly competent knowledge of transplant patient care and apheresis collection a plus.  Global filing and product launch experience strongly preferred.
• Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology and risk prevention/mitigation strategies
• Ability to establish and maintain infrastructure and processes integral to clinical project management
• Experience managing cross functional R&D programs from preclinical stages through full development with associated milestones and regulatory filings
• Ability to prioritize and execute tasks both as an individual contributor and in a team-based setting
• History of motivating others to deliver to important milestones while maintaining a positive, transparent and collaborative team environment
• Capable of assessing and updating detailed project timelines in meetings to guide and align study team members
• Ability to evaluate meeting minutes and materials for required updates to project timelines
• Ability to work on complex and multiple projects while exercising critical thinking with minimal supervision
• Solid attention to detail and excellent organization skills
• Ability to establish priorities, operate with a sense of urgency and collaborate (interpersonal, relationship management) with the study team, cross functional team members
• Demonstrates problem solving skills, demonstrates leadership skills, self-motivated and adaptable to a dynamic environment
• Computer skills including proficiency in the use of SMARTSHEET, Word, Excel, PowerPoint, Spotfire, Tableau and other organization tools
• Proficient with SharePoint with filing systems is desirable
• Ability to deal with time demands, incomplete information or unexpected events
• Must display strong analytical and problem solving skills
• Outstanding organizational skills with the ability to multi-task and prioritize
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities