Global Clinical Program Manager, Medical and Scientific Affairs

United States of America, Indiana, Indianapolis

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Summary

The Global Clinical Program Manager takes overall accountability for the planning, implementation and execution of innovative, fit for purpose, time and cost efficient, high quality evidence generation projects for the LCT Project Team(s) (PTs). He or she does this by leading a functional/cross-functional team which allows the close collaboration with representatives from the MSA functional areas and their sub functions (Clinical Science, Medical Affairs and Clinical Operations: Study Management, Investigational Site Management, COSS and Process & Functional Excellence) and as needed with representatives from functions outside of MSA e.g. R&D, Regulatory or Statistics and Data Management.

A seasoned professional with wide-ranging experience.  Deals with diverse and often times complex issues, where analysis may require in-depth evaluation of many factors. Exercises judgment in evaluating methods and may determine criteria for obtaining solutions. May coordinate the activities of other employees. Networks with senior internal and external personnel in area of expertise as well as some key contacts outside area of expertise.

Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.

What you do

  • Is the MSA primary point of contact for the LCT Project Team (PT), represents MSA (Clinical Science, Clinical Operations and Medical Affairs) at the LCT PT and represents the LCT PT within MSA. In collaboration with the MSA Functional Lead, drives strategic alignment with all functions represented at the LCT PT, like e.g. R&D, Regulatory Affairs, Quality, Operations, GCS. Provides LCT PT with external/customer know-how, feedback and requirements for the development of new products.
  • Leads MSA functional/cross-functional teams, proactively drives alignment between MSA functional areas (Clinical Science, Clinical Operations and Medical Affairs) and acts as key contributor to the CPS LCT/PT strategy. Drives MSA (Clinical Science, Clinical Operations and Medical Affairs) decisions at PT level by adequately involving experts from MSA functional areas and MSA Clinical Operations sub-functions. Drives MSA PT level teams to stay on top current market developments and competition.
  • Ensures MSA alignment on new concepts for evidence generation and process improvements.
  • Closely communicates with MSA functional management on project resource requirements and adequate allocation of MSA resources to manage planned workload. Drives the development and follow-up of project and study risk management plans.
  • Takes overall accountability for all evaluation plans, study protocols and study reports to ensure high quality and consistency in close collaboration with the Study Teams. Ensures adequate MSA review of DCC milestone documents/deliverables from other functions in close collaboration with respective MSA functional areas. Reviews and provides input to all Clinical Utility and Clinical Performance study protocols and study reports within his or her project(s) to ensure high quality and consistency. Actively supports pre- and post-launch registration activities for his / her project(s) in close collaboration with representatives of the functional / cross-functional team(s).
  • Drives and ensures a harmonized approach to planning across various projects enabling early strategic planning in alignment with the relevant MSA functions. Maintains oversight and manages MSA project / study quality, timelines, budget and risks in alignment with the representatives of the MSA functional areas.
  • Drives change and functional excellence to new and existing processes in close collaboration with MSA Process & Functional Excellence to ensure MSA works to the highest standards that help keep our Time to Market as short as possible.
  • Closely aligns and guides Planning Manager(s) on budget and staff allocation tracking status and ensures up to date accurate reporting readiness (Finance KPIs). Provides regular project(s) updates to the MSA LT, Global Head Forum, Clinical Operations LT (COLT) and the MSA Teams CPS.
  • On average 30% international travel

Who you are

  • Bachelor’s degree in medical technology, chemistry, biology or other life sciences
  • 7+ years experience in the Pharma and/or Diagnostics Industry with proven track record of clinical trials experience in project or study leadership roles across multiple programs and disease areas in a Diagnostics, Pharma or CRO setting
  • Experienced in biochemical, chemical or biophysical area with special detailed knowledge on study types or specific diagnostic areas as well as experience in multiple diagnostic / system areas
  • Knowledge of applicable standards and regulations for clinical trials and lab conduct (International Conference on Harmonization / WHO Good Clinical Practice standards (ICH-GCP), IVDD/IVDR, FDA regulations)
  • Deep understanding of Diagnostics Development Process (Design Control and Commercialization) as well as associated processes (pre-DCC, Post-Launch, activities throughout a product’s life cycle) is essential for this role
  • Profound project management experience and cross-functional leadership skills that serve, inspire and motivate others within the organization
  • Proficiency and experience with planning and tracking tools such as e.g. PRIME, GRRP, CTMS
  • Knowledge of the typical experiments to characterize the performance of an IVD or Medical Device, as well as practical experience in international clinical study management, study protocol design, report writing and statistics
  • Familiar with good documentation practices and record retention processes
  • Fluent in English, both in writing and oral conversation
  • Computer literacy

Preferred Experience

  • Master’s / PhD / PharmD / MD in Life Science and/or relevant disease area expertise
  • Soft skills:
    • Open, active and inspiring communicator (written and verbal) with a professional communication style and business behavior in interactions within and outside of Roche
    • Confident and influential approach, ability to provide clear instructions/guidance to teams at the same or higher levels in a global organization
    • “Can do”-mentality
    • Strong strategic, analytical and critical thinking, combined with the ability to make decisions in complex and ambiguous situations
    • Makes independent choices and takes responsibility for own actions
    • Quick in the uptake of difficult and complex situations, anticipates potential problems, acts quickly/proactively and resolves them effectively
    • Structured approach to plan and manage large number of activities, ability to apply a sense of urgency wherever needed 
    • Ability to motivate, train and lead teams in a matrix organization, understands the needs of others and create a positive working environment
    • Supports a culture of empowerment, innovation and continuous learning by serving as a change ambassador to foster continuous improvement
    • Ability to build trustful relationships with peers in a multi-cultural environment, ability to operate

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