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$1 - $1
Job Type
Direct Hire
Nov 15, 2018
Job ID
The job holder is accountable for driving improvement focused initiatives across Clinical Operations and for the development and implementation of effective processes and best practices for SP&CO and group functions. S/he aligns with the evolving business strategy throughout the organization and develops and maintains the strategic framework for efficient information management as well as the portfolio of projects/initiatives driving improved efficiency. The postholder is accountable for stakeholder management and collaboration activities within the Business Operations Management function, the broader Clinical Operations organization and other key group stakeholders such as the DTAs in the delivery of business processes and initiatives.
  • Lead or contribute to cross-functional, global initiatives focusing on innovative approaches, processes and best practice development
  • Develop and maintain the governance model and portfolio framework for Clin Ops initiatives
  • Oversee the development of robust business cases (including timeline, budget and resources) through the implementation and roll out of initiatives.
  • Make recommendations (areas of focus and work plan design) for internal initiatives focused on understanding and improving work processes and addressing challenges to enhance efficiency and ensure compliance.
  • Collaborate across the Business Operations function to understand current performance and business challenges associated with Clinical Program delivery.
  • Maintain awareness of external innovation and lead introduction of new processes, tools and technologies into the Clin Ops organization for evaluation and potential uptake.
  • Partner with Clin Ops Leadership and (Global) Heads to align on the relevance and benefits of proposed initiatives, key deliverables and milestones
  • Create and deliver value add initiatives in response to identified business need utilizing internal and external resources with minimal interruption to the business
  • Support initiative teams with skills in process excellence, project management, facilitation, problem solving, design thinking, metrics development, influence and value creation to drive toward required outcomes.
  • Develop business plans that support and introduce solutions for strategic issues that impact the business with learnings derived from initiatives
  • Accountable for global process team oversight and global business process management activities to ensure effective support of group  process effectiveness and continuous improvement including alignment with GCP/GVP regulations via interfaces with Global Head of QPE and participation in Process and procedure Committee (PPC)
  • Accountable for strategic planning and oversight of Initiatives and Process function
  • Accountable for Process Management metrics  and governance including leadership of the group process Board to support continuous improvement
  • Accountable to set the strategy of Business Process Management within group (including BPM software solution)
  • Provide line management including coaching/mentoring for a senior group of Initiative and Process Managers.
  • Collaboration with senior leadership within group as well as other key groups to develop cross functional solutions to better support seamless global clinical development studies & programs
Qualifications (Minimum):
  • Bachelors Degree, with a preference for an Advanced Degree in related field
  • Significant experience in Pharmaceutical/Biotech industry
  • Relevant certifications desirable (lean sigma, PROCI etc)
Experience, Skills, Knowledge:
  • Substantial understanding of Clinical Development activities from First in Man thru Proof of Concept
  • Current knowledge of leading edge tools and technologies which drive innovation in clinical trials; willingness to seek out or develop better methodologies and lead evaluation initiatives.
  • Use analytical skills and judgment to identify solve problems
  • Communicate complicated matters in a simple, structured way
  • Get work done through cooperation with other groups with or without direct reporting relationship to position
  • Proven ability to decompose complex problems into defined workstreams
  • Strong ownership mentality and action-oriented approach
  • Strong financial acumen: proven abilities for effective planning, development and oversight of project budgets and other resources
  • Independent thinker who is self-motivated and thrives in a fast-paced work environment.
  • Demonstrated experience in leading global team within a cross functional organization
  • Must demonstrate strong knowledge of business process management and clinical trial management
  • Broad understanding of international regulations, processes and issues in drug development. Includes expert-level knowledge of GxP (Good Practices for quality guidelines and practices in the pharmaceutical/biotechnology or related industry), GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)
  • Previous project management experience across the drug development process is important.
  • Demonstrated experience in partnering within a large complex global organization to support process management activities
  • Confident and competent when interacting with varying levels of internal/external management: stays focused and on-point, and is able to raise problems or challenges in a productive and mature manner
  • Strong negotiation skills: can effectively drive discussions and decisions toward desired end results
  • Proven track record of effective decision-making: makes good business decisions and exercises sound judgment. Consistently and effectively balances decisions with imperatives for ethics and efficacy
  • Proven teamwork skills: has a proven track record of working highly effectively, efficiently and collaboratively with others. Has proven experience and skills working with multidisciplinary teams