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Senior Program Leader (Drug-Eluting Stents) – Top $$/Will Relo
RTP, NC 27709 United States
Research and Development
Our client, a NC-based medical device company that is developing drug-eluting stents in the cardiovascular space, is actively recruiting for an exceedingly savvy Program Leader with substantial success driving medical devices through the approval process, to lead its premier product(s). Particular expertise in stents will be important.
Company will pay absolute top dollar, including relo to attract and retain a star.
This Program Leader (client is open on level) will report to the CEO and will be responsible for ensuring that all parties (both internal and external) are working in sync to ensure a successful outcome (approval). He/she will be the chief facilitator and communicator. Seek a seasoned leader who will provide direction, clarity, focus and support.
Key things to note:
? This Program Leader will be a lead FDA liaison. Similar experience and substantial understanding of FDA timelines, standards and practices expected and essential
? This is a global effort and familiarity with ROW regulatory standards also important
? This is an independent contributor role directing the work of cross-functional teams. Seek an adept leader of people and process, who is also hands-on and resourceful
? Drug eluting stent expertise is a must
Responsibilities will include:
? Develop and execute sound, data-based project plans incorporating all activities required including critical path analysis and risk mitigation plan
? Lead teams to anticipate and resolve project issues/delays
? Track to ensure completion of project on time and on budget
? Prepare technical reports, summaries, protocols and quantitative analyses
? Apply best practices in the initiation, planning, execution, control and closing of projects
? Maintain documentation and procedures to ensure compliance with regulatory, scientific and legislative standards
? write project/design control documents, SOPs, protocols, technical reports, and other documents as needed
This is a critical role and finding the right candidate is top priority at this time.
The right candidate will offer a related degree and 10+ years of significant success leading R&D medical device projects as well as manufacturing process development from clinical through approval. Drug-eluting stent expertise is a must. Other priorities include:
? Proficiency in design control to support US Regulatory approval as well as Europe and ROW (China and/or Japan a plus)
? Ability to create a work breakdown structure, create a detailed project plan utilizing MS Project/Gantt Charts, and understand how to identify and execute the critical path
? Must be exceptional at presenting to executive leadership team showcasing strong analytical skills and problem solving skills
? PDMA or PMP certification a plus
Finally and critically, we seek candidates whose exceptional technical credentials are complemented by a track record of exceptional Product Leadership. Seek candidates with a hands-on, make-things-happen leadership style, astute and adaptive project and people management skills as well as persuasive and adept communicative styles.
This is a Direct Hire opportunity and an immediate need. Please forward Word resume for prompt consideration.
Frankel Staffing Partners proudly recruits on behalf of premier employers in the Triangle (and beyond). We specialize in Office Support, Life Science and other Professional Services positions. To view our current openings, please visit our website at www.frankelstaffing.com.
North Carolina Biotechnology Center