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Sr Director, Clinical Program Optimization

Company: Insmed Incorporated
Location: Bridgewater
Posted on: August 6, 2022

Job Description:

Insmed is a growing global biopharmaceutical company powered by our purpose to deliver life-altering therapies to small patient populations experiencing big health problems. Our most valuable resource is our employees, and a patients-first mentality guides everything we do. Today, we are building a world-class team of talented individuals who are willing to challenge the status quo, solve problems, and work collaboratively and with a sense of urgency. Come join us if you are ready to roll up your sleeves and be recognized for your efforts while working alongside team members who share your passion for serving patients and their families.Named -Science's -2021 Top EmployerInsmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in -Science's -2021 Top Employers Survey.A Certified Great Place to WorkWe believe we have built something truly special at Insmed, and our employees agree. Each day, we show up for each other and for the patients we serve. That's why we were recently certified as a Great Place to Work in the U.S.The Senior Director, Clinical Program Optimization is responsible for identifying areas of greatest opportunity to improve clinical trial performance and increasing consistency, efficiency, and effectiveness across programs. - This dynamic role requires the ability to analyze situations, synthesize recommendations, and lead special projects and cross-functional process improvement initiatives. - The Individual needs to be able to plan long-term and visualize the future state while remaining focused and deeply involved in executing short-term activities to meet planned goals. - The ideal candidate will have strong foundational knowledge and experience in Clinical Operations, which can be tapped into to drive his/her thinking. - The Role will serve as a member of the Development Operations Leadership Team and participate in setting the strategic direction for the Department and executing against functional goals. - -This is a non-supervisory position, but could have coaching and mentoring responsibilities. - -This role could have responsibility to oversee vendors and/or Contractors. -Additional representative responsibilities will include, but not necessarily be limited to, the following: -Work collaboratively to identify and solve pain points

Work with Development Operations and Cross-Functional Stakeholders to improve business outcomes by identifying pain points or inefficiencies and leading solution generation and implementation:
Define key business questions, analyze data and trends, identify improvement opportunities, and develop process improvement plans. Lead development and presentation of business cases, summarizing the situation, opportunity, cost, expected value returned and anticipated challenges or risks.Work with Clinical Trial Ops, Clinical Business Ops and Study Teams to optimize clinical programs:
Refine and/or streamline operational strategies, vendor partnerships, and systems.Identify lessons learned and best practices through evaluation of processes and methodologies. Increase reliable delivery against commitments (e.g., clinical trial milestone targets and budgets).Stimulate key business processes (e.g., study feasibility, start-up, enrollment).Use KPIs and metrics to demonstrate improvement over time and acceleration of clinical programs.
Develop an understanding of effectiveness and efficiency at the Program- and regional-levels and integrate into Portfolio- and Department-level views. Identify opportunities to standardize/harmonize and ensure initiatives align with our overarching strategy.Propose new ways of working by applying knowledge of Industry trends and best practices with an assessment of internal processes and functional capabilities. Support the development and implementation of new/enhanced standards, tools, and templates to help Teams be more efficient and effective.Identify and evaluate new and emerging clinical trial solutions and technologies aimed at trial optimization.Engage in external scouting (e.g., conferences, special interest groups, networking events) to identify new vendors and partner with Procurement on category analyses to enhance our strengths and fill gaps.Metrics Champion /Cycle Time Optimization
Function as the SME for clinical trial operational performance metrics management and continuous improvement. Analyze and report out on performance metrics relative to industry benchmarks at the enterprise, Project, Regional and CRO Partner level using internal and external (e.g., KMR) data sources.Harness clinical trial performance metrics to drive cycle time optimization. -Demand Planning and Capacity Management
Own resource management and demand/capacity planning process for the Dev Ops Leadership Team. Develop strategies to help the Team grow/scale up (FTE, Contractor, FSP) to meet pipeline needs. -Leadership
As a LT Member, contribute to setting annual clinical trial and non-project initiative goals and prioritization. Serve as a central member on strategic decision-making teams. Utilize negotiation skills, cultural sensitivity/awareness, and technical knowledge to win support and cooperation from other functional areas and influence decision making. -Miscellaneous Run clinical program/trials, if needed.Qualifications:
Bachelor's Degree required. Master's Degree preferred. Minimum of 12 years of relevant and progressive Dev Ops/Clin Ops experience required, including a minimum of 10 years running clinical trials for a Sponsor company.Leadership experience requiredKnowledge & Experience:
Proven experience developing and executing strategies which elevate organizational performance. Adept at identifying opportunities to enhance productivity and driving positive business outcomes. Inquisitive Leader who challenges the status quo and possess a continuous improvement mindset. Strong foundation and experience running global clinical trials/programs, preferably in rare diseases, to enable critical evaluation of processes and identification and implementation of best practices.Deep knowledge of drug development and the interconnectivity between Functions. Proven ability to develop strong cross-functional partnerships and work collaboratively to solve problems. -Effectively negotiates and influences to successfully lead Teams and solve high impact problems. Demonstrates leadership skills necessary to serve as a Leader within Dev Ops and be viewed as same by Insmed Senior Management, cross-functional Stakeholders, and external Suppliers. Understands, identifies, communicates, and mitigates risks at both strategic and operational levels. Ability to set goals, prioritize and manage multiple responsibilities simultaneously.Detail- and quality-oriented with a demonstrated track record of driving projects/deliverables to completion within established timelines, budget, and allocated resources.Well-connected in the Industry with deep knowledge of relevant vendors and software/technology.Successfully exhibits Insmed's core values: Collaboration, Accountability, Passion, Respect, and Integrity. Experience functioning at a high level in a dynamic workplace. Ability to think strategically and translate ideas into tactical, actionable plans.Experience in the areas of Change Management and Project Management. Functions independently and is a self-starter.Up to 20% travel -Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. -Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. -Please note that we review every submission, and we will keep all submissions on file for six months. -

Keywords: Insmed Incorporated, Trenton , Sr Director, Clinical Program Optimization, Healthcare , Bridgewater, New Jersey

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