Talent.com
Director, Lead of Strategy for Device Product Assessment & Innovation

Director, Lead of Strategy for Device Product Assessment & Innovation

Kansas StaffingTopeka, KS, US
9 hours ago
Job type
  • Full-time
Job description

Director, Lead Of Strategy For Device Product Assessment & Innovation

At our Company, we are enhancing our investment in device development and commercialization capabilities to support our growing pipeline of drug-device combination products. Our integrated team is responsible for the entire spectrum of activities from innovation, development, commercialization, as well as product lifecycle management for drug-device combination products. Reporting to the Sr. Director of Device Product Assessment & Innovation (DPAI), the Director, Lead of Strategy for Device Product Assessment & Innovation will define and build strategic roadmaps to manage governance, operations, and cross-functional processes that drive efficient, discovery facing innovations and decision-making strategy for all elements of early development. They will lead various early development and innovation initiatives to support continuous improvement that translates DPAI strategy and objectives to execution.

Key Responsibilities

Strategic Leadership, Business Acumen & Innovation

  • Define strategic priorities and roadmaps aligned with portfolio and business objectives.
  • Build the framework for, and operationalize, a Device Target Product Profile (DTPP) with insights from the Target Candidate Profile (TCP) and Target Product Profile (TPP) to define clear device requirements aligned with commercial and clinical goals.
  • Construct overall development strategies, timelines, and transition plans into fully commissioned Device Development Working Groups, including resource planning projections.
  • Monitor industry trends, state of the art, and emerging technologies to inform and evolve strategic direction.

Stakeholder Engagement, Partnerships & Influence

  • Identify key stakeholders / opinion leaders across our company to establish network mapping.
  • Drive engagement sessions to identify gaps and challenges in the device innovation space; lead efforts to co-develop solutions.
  • Advocate for early consideration of device usability, human factors, and differentiated product attributes, leveraging knowledge of competitive and commercial landscapes and through work with the broader DPAI team.
  • Establish means to engage with development and in-line product support teams to identify lifecycle management opportunities for assets currently in development and / or marketed.
  • Develop and execute communication plans that ensure stakeholder alignment and foster commitment across divisional / departmental stakeholders.
  • Decision Making & Continuous Improvement

  • Develop and implement governance structures and operating models for early device development and innovation.
  • Integrate elements of local governance into the border our Company governance structures (ex. DCRC, LDRC, CMC-wide).
  • Establish key performance indicators (KPIs) to measure progress towards organizational goals and drive performance excellence.
  • Drive continuous improvement across processes and decision-making frameworks that include end to end (from early discovery to lifecycle management).
  • Required Qualifications

    Education

  • Bachelor's degree required with a concentration in a scientific-related discipline strongly preferred.
  • Advanced scientific degree (e.g., MS, PharmD, Ph.D.) preferred.
  • Project Management certification / training (PMP) and / or coursework & training in Project Management preferred.
  • Experience

  • Minimum of 10 years of experience in pharmaceutical / medical device industry with at least 5 years in project or program management roles.
  • Demonstrated experience in leading organizational transformation initiatives and driving strategic change.
  • Experience with drug-device combination product development, regulatory requirements, and commercialization strongly preferred.
  • Track record of successfully managing complex, cross-functional projects and initiatives.
  • Experience in building and leading high-performing teams.
  • Skills and Competencies

  • Strategic thinking and independent decision-making abilities with excellent business acumen.
  • Demonstrated ability to develop strong, trust-based collaborative relationships to drive change and execute priorities with diverse stakeholders.
  • Exceptional communication skills with the ability to communicate clearly, effectively, and tactfully at all organizational levels.
  • Strong understanding of GMP and regulatory requirements for drug-device combination products.
  • Proven ability to identify risks to project timelines, scope, or deliverables and escalate appropriately.
  • Experience in designing governance processes that provide executive visibility and decision support.
  • Demonstrated situational leadership in high-ambiguity settings and creative problem-solving.
  • Effective at energizing others, establishing clear goals, delegation, mentoring, and coaching.
  • Strong facilitation skills for leading cross-functional meetings and workshops.
  • Required Skills

  • International Product Development
  • Leadership
  • Leadership Training and Development
  • Management Process
  • Medical Devices
  • Medical Product Development
  • People Management
  • Product Demonstrations
  • Product Development Consulting
  • Product Development Design
  • Product Development Quality
  • Safety Needles
  • Team Management
  • The salary range for this role is $153,800.00 - $242,200.00. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https : / / jobs.merck.com / us / en / compensation-and-benefits .

    Create a job alert for this search

    Director Of Strategy • Topeka, KS, US

    Related jobs
    • Promoted
    Remote Finance Director - AI Trainer ($50-$60 / hour)

    Remote Finance Director - AI Trainer ($50-$60 / hour)

    Data AnnotationLawrence, Kansas
    Remote
    Full-time +1
    We are looking for a finance professional to join our team to train AI models.You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the quality of ...Show moreLast updated: 18 days ago
    • Promoted
    DSP (Direct Support Provider) - Full-Time

    DSP (Direct Support Provider) - Full-Time

    COF Training Service IncOsage City, KS, US
    Full-time +1
    Direct Support Professional Difference Maker or Caregiver.Since 1968, COF Training services Inc.We are looking for dependable, patient, and compassionate hands-on caregivers to help assist our ind...Show moreLast updated: 3 days ago
    • Promoted
    Medicaid Eligibility Specialist (ONSITE)

    Medicaid Eligibility Specialist (ONSITE)

    Conduent State Healthcare, LLCHolton, KS, US
    Full-time
    Through our dedicated associates, Conduent delivers mission-critical services and solutions on behalf of Fortune 100 companies and over 500 governments - creating exceptional outcomes for our clien...Show moreLast updated: 4 days ago
    • Promoted
    Career Advisor Senior

    Career Advisor Senior

    InsideHigherEdLawrence, Kansas, United States
    Full-time
    Position OverviewThe KU School of Business is seeking a student services professional to join the Business Career Services (BCS) team to advise and assist KU undergraduate Business students with ca...Show moreLast updated: 6 days ago
    • Promoted
    Asst / Assoc / Full Prof of the Practice, Edward Campus Health Sciences

    Asst / Assoc / Full Prof of the Practice, Edward Campus Health Sciences

    InsideHigherEdLawrence, Kansas, United States
    Full-time
    Position OverviewThe Bachelor of Health Sciences Program at the University of Kansas (KU) is housed in the KU School of Professional Studies (SPS), which is located on the KU Edwards Campus (KUEC) ...Show moreLast updated: 30+ days ago
    • Promoted
    Occupational Therapist

    Occupational Therapist

    Encompass HealthRossville, KS, US
    Full-time +1
    Occupational Therapist Career Opportunity.Your Calling, Close to Home and Heart.Are you in pursuit of a career that's more than a job, one that aligns with your heart and community? We believe ...Show moreLast updated: 24 days ago
    • Promoted
    Academic Advisor Senior

    Academic Advisor Senior

    InsideHigherEdLawrence, Kansas, United States
    Full-time
    Position OverviewJayhawk Academic Advising (JAA) is a unit within Academic Success, a division of Academic Affairs.JAA provides comprehensive academic advising services for prospective, new and cur...Show moreLast updated: 24 days ago
    • Promoted
    Assistant Researcher Senior

    Assistant Researcher Senior

    InsideHigherEdLawrence, Kansas, United States
    Full-time
    Position OverviewThe Mass Spectrometry and Analytical Proteomics Laboratory (MSAPL Core) is seeking a highly motivated and experienced person to join the MSAPL core. The Assistant Research Senior is...Show moreLast updated: 30+ days ago
    • Promoted
    Lead, MarTech Capabilities - Next Best Action Engine

    Lead, MarTech Capabilities - Next Best Action Engine

    Kansas StaffingTopeka, KS, US
    Full-time
    Lead Product Manager For Enterprise NBA Decisioning.Become a part of our caring community and help us put health first.Humana is advancing its enterprise personalization strategy to deliver timely,...Show moreLast updated: 1 day ago
    • Promoted
    Director, Strategic Planning & Effectiveness Oncology Portfolio

    Director, Strategic Planning & Effectiveness Oncology Portfolio

    Kansas StaffingTopeka, KS, US
    Full-time
    Director, Strategic Planning & Effectiveness Oncology Portfolio.Japan with operations in the U.With several marketed products and a diverse pipeline of early- to late-stage investigational assets,...Show moreLast updated: 1 day ago
    • Promoted
    Local Engineer Liaison

    Local Engineer Liaison

    InsideHigherEdLawrence, Kansas, United States
    Full-time
    Position OverviewThe University of Kansas Transportation Center (KUTC) is searching for a.Full-Time Local Engineer Liaison. This position will provide traffic engineering services, and act as a loca...Show moreLast updated: 30+ days ago
    • Promoted
    Operations & Strategy Lead, Life Sciences

    Operations & Strategy Lead, Life Sciences

    Kansas StaffingTopeka, KS, US
    Full-time
    Datavant is a data platform company and the world's leader in health data exchange.Our vision is that every healthcare decision is powered by the right data, at the right time, in the right format....Show moreLast updated: 3 days ago
    • Promoted
    Direct Support Professional -Difference Maker

    Direct Support Professional -Difference Maker

    COF Training Service IncOsage City, KS, US
    Full-time +1
    Direct Support Professional Difference Maker or Caregiver.Since 1968, COF Training services Inc.We are looking for dependable, patient, and compassionate hands-on caregivers to help assist our ind...Show moreLast updated: 2 days ago
    • Promoted
    Delivery Driver - No Experience Needed

    Delivery Driver - No Experience Needed

    DoorDashSaint Marys, KS, United States
    Full-time +1
    DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day. As a Dasher, you’ll stay busy with a variety o...Show moreLast updated: 8 days ago
    • Promoted
    Senior Director of Core Research Laboratories

    Senior Director of Core Research Laboratories

    InsideHigherEdLawrence, Kansas, United States
    Full-time
    Position OverviewThe Senior Director of Core Research Laboratories acts as the primary liaison, leading strategic operations and shaping service pricing strategies for all KU Core Labs across the L...Show moreLast updated: 15 days ago
    • Promoted
    TRIO Advisor

    TRIO Advisor

    InsideHigherEdLawrence, Kansas, United States
    Full-time
    TRIO college access program funded by the U.Through early intervention, this program is designed to encourage participants to remain in school, graduate from high school, and to pursue post-seconda...Show moreLast updated: 30+ days ago
    • Promoted
    Assistant Professor - Radar Systems and Remote Sensing

    Assistant Professor - Radar Systems and Remote Sensing

    InsideHigherEdLawrence, Kansas, United States
    Remote
    Full-time
    Position OverviewThe University of Kansas (KU) Department of Electrical Engineering and Computer Science (EECS) seeks outstanding individuals for a full time, tenure-track position at the rank of A...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    New Product Integration Director

    New Product Integration Director

    Kansas StaffingTopeka, KS, US
    Full-time
    New Product Integration Director.Meta is seeking an experienced New Product Integration Director to drive the end-to-end process of transitioning hardware platforms from validation through to produ...Show moreLast updated: 9 hours ago