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Head Strategy & Business Transformation

Company: J&J Family of Companies
Location: La Jolla
Posted on: September 24, 2022

Job Description:

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat, and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it, and we are guided by our Credo: https://www.jnj.com/credo/ . Learn more at www.janssen.com (file:///C:/Users/jamie%20yacco/AppData/Local/Microsoft/Windows/Temporary%20Internet%20Files/Content.Outlook/JHNHJA6O/www.janssen.com) and follow us @ JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies. Portfolio Delivery Operations (PDO), part of Global Development (GD), is responsible for the operational strategy and delivery of the global clinical portfolios across all the therapeutic areas within Janssen. The Portfolio Delivery Operations (PDO) Head of Strategy and Business Transformation reports to the VP, Head of PDO-xTA. They are responsible for leading, in collaboration with the appropriate stakeholders, a robust future ready strategy and continue to identify opportunities under the global business transformation tactical plan for the PDO organization. Evolutions in Clinical Trials are occurring within both the internal and external environment such as artificial intelligence, wearables, mobile research application platforms, real-world data, home and community alternative research locations, precision medicine (e.g. biomarker-based trial qualification), advances in clinical trial data and quality monitoring, and more, which impact how JnJ conducts clinical trials worldwide. As a result, the PDO organization is critical to the organizations adoption of decentrialized trials and this role is tasked with partnering with applicable stakeholders for this transformation. Additionally, the changing regulatory and privacy landscape across our global footprint requires constant assessment. This individual will play a key leadership role in ensuring PDOss ability to partner with all Global Development function to drive the adoption of future facing initiatives that advance they way Janssen designs, deploys, and successfully recruits for its clinical trials. Principal Responsibilities: The PDO Head of Strategy and Business Transformation will have the following principle responsibilities:

  • Strategy Development for PDO
    • Collaborates to develop a landscape of short-, medium- and long-term roadmap representative of the future facing strategies required to gobally advance the PDO organization. Creates infrastructure (meetings, townhalls, working/strategy sessions) that enables the successful collaboration of the three TA aligned organizations of PDO that not only supports the three VPs but allows for harmonized ways of working.
    • Collaborates with Global Development and TA Strategy & Operations Leads to provide insights to inform the central strategy and approach to live into Better Trials Made Together.
    • Partners with key functions to identify and implement process improvement opportunities across PDO which includes but is not limited to: Regulatory, Quality, Privacy, Legal, Clinical Supplies, Contracting.
    • Leads the planning, implementation and change management of identified strategic iniaitives
    • Acts a central point of contact within PDO for internal/external collaborators for cross PDO inititiavives, process improvement, and quality compliance and ensures alignment
    • Develop, deploy, and maintain suite of metrics and reports to enable the organization to track performance and progress in accordance with cross PDO goals and objectives
    • Quality/Vendor Management & Compliance
      • Serves as point of contact and partner with BQRC on PDO quality management, compliance and concerns
      • Manages team to ensure CAPA process and reporting are managed and successfully resolved
      • Identifies shared cross PDO vendors and coordinates requirements, reporting, and relationships with PDO stakeholders
      • Liaise with Procurement, Legal, Privacy, etc. on vendor onboarding, governance, and budget coordination
      • Trials2You Program Leadership
        • Partners with GCO Head of SBT in the designing and implementing Decentralized Clinical Trials (DCT) in Janssen Research and Development and Medical Affairs Operations.
        • Leads a matrixed team of PDO experts in DCTs, including individual product- or service- (capability) business owners, trial design architects/consultants, and functional liaisons
        • Serves as point of contact for PDO with a bias towards action for Trials2You and effectively leads the organization to adoption.
        • Partners with the Trials2You Process Owner as part of the protocol concept value stream; acts signatory to PDO applicable policies and SOPs
        • Stakeholder Management
          • Creates and builds collaborative relationships across the JnJ organization in order to develop and delivery PDO strategy in an effort to delivery innovative clinical trials.
          • Pro-actively communicates with PDO leadership and draws in expertise to advance the strategy
          • Develops a robust Change Management and communication plan with input from local and global communications partner to deliver effective communication for/to PDO.
          • Manage cross PDO strategic deliverables in a timely fashion and in accordance with GD and PDO leaders.
          • Implementation Planning and Delivery Oversight
            • Influence or lead the design, structure and delivery of various centralized capaclities, such as Standards & Methods, Processes and Tools, Training & Coaching PDO University, Vendor Mgnt, (Training) Compliance Principal Relationships: Primary Reporting Structure : Reports to Head of Portfolio Delivery Operations -xTA. Leader of S&BT Directors, Operations Excellence Directors, T2U team and various support staff. Primary interfaces: Peers to members of the PDO Leadership Team, Extended PDO LT members. Actively engage with leaders of Global Development, Therapeutic Areas, and Enterprise. QualificationsEducation and Experience Requirements:
              • Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy). Advanced degree in a scientific discipline and/or Masters degree is preferred.
              • Minimum of 10 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site.
              • Expertise or experience working in novel clinical research methods, particularly in digital and decentralized clinical trials.
              • Deep knowledge and experience in organizational and capabilities transformations.
              • Excellent communication and leadership skills.
              • P roven ability to foster team productivity and cohesiveness.
              • Ability to manage complexity under pressure.
              • P roven track record of people and project management.
              • Strong in strategy development , project execution, stakeholder management, training and excellent interpersonal skills. Strong decision-making and financial management skills.
              • F lexibility to work in a rapidly changing environment with the appropriate sense of urgency.
              • E xperience in transforming organizations in response to b usiness needs.
              • Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required.
              • Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations.
              • Ability to synthesize and evaluate data generated from various reports and sources.
              • Demonstrated skills in effective communication with various internal and external stakeholders (e.g. investigational sites, ethics committees, health authorities. etc.). Other:
              • Operates with limited supervision.
              • Proficiency in English .
              • Computer literate .
              • Strong interpersonal and negotiating skills.
              • Excellent organizational skills and ability to collaborate and handle multiple priorities within a matrix environment.
              • Perform activities in a timely and accurate manner.
              • Can travel internationally up to 25% of the time
              • This position can be located in and report into an office in the following Janssen locations: Beerse, BE, any of our offices in New Jersey, Sping House, PA, the United Kingdom, La Jolla, CA and San Francisco, CA. At Johnson & Johnson, were on a mission to change the trajectory of health for humanity. That starts by creating the worlds healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location. Primary LocationUnited States-New Jersey-Raritan-920 US Highway 202Other LocationsEurope/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-New Jersey, North America-United States-Pennsylvania-Spring House, North America-United States-California-San Francisco, North America-United States-California-La JollaOrganizationJanssen Research & Development, LLC (6084)Job FunctionR&DRequisition ID2206064406W

Keywords: J&J Family of Companies, San Diego , Head Strategy & Business Transformation, Other , La Jolla, California

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