Band
Level 6
Job Description Summary
Job Description SummaryThe Clinical Operations Program Head (COPH) is accountable to deliver data-driven, actionable operational and strategic insights for execution of a clinical development program and all associated trials by representing GCO at the Global Clinical Team (GCT) as well as at the Global Program Team (GPT). The COPH is accountable to plan the strategic operationalization of clinical drug development programs and trials in line with the needs of the EPTs/GPTs.
This specific COPH role may be focused within Immunology, CRM or Neuroscience programs.
The COPH leads the GCO sub-team to determine the GCO operational input to planning prior to any given development tollgate and to prepare the Operational Execution Plan (OEP), which is authored and owned by the COPH. The OEP incorporates both data-derived insights as well as country insights which enable informed decision-making, identify complexity, enable the generation of risk mitigation plans to reduce chances of delays, allow easier adaption of actions, and ensure transparency of the GCO operational position and the downstream delivery of program and trial milestones. To do this, the COPH owns the early viability assessments and program and trial feasibility of the planned programs and trials.
During the execution of the trial (concept sheet onwards), the COPH will continue to lead the GCO sub-team to ensure the progress of the trial is in line with the OEP, to proactively deploy mitigation actions whenever necessary to ensure timely delivery of the trial as per plan.
Experienced leader guiding members of the organization through the GCO organizational evolution, the evolution of new “product aligned” ways of working and of our overall culture. He / she champions a product oriented agile mindset, fostering a culture of experimentation combined with accountable delivery and overall high performance.
Job Description
Major accountabilities:
- Lead operational delivery of the clinical development program and is responsible for the overall operational execution of the clinical program and related trials, as aligned with the IDP/CDP.
- Single GCO point of contact for assigned clinical development program and related trials.
- Key partner to GPCH during strategy, planning and execution stage of the program and related trials ensuring that the clinical science and strategy are consistently harmonized with an operationally feasible approach within the OEP-defined operational boundaries, so that the trials generate reliable information to answer the research questions and support decision making while protecting study participants.
- Leads operational delivery of the assigned program and related clinical trials and for all related strategic planning, prioritization of activities within that program and owns the early viability and feasibility assessment done by the GCO sub-teams as well as the development of operational scenarios for the execution of assigned programs and trials.
- Oversight and management of clinical trial budget for the assigned program and trials per OEP aligned with financial toll gates (e.g. IMB) and oversight of scope changes throughout the trial and program duration.
- Acts as a key partner to the GCO DU Head to use the operational insights developed with the GCO sub-team to actively shape the GDD DU strategy by driving the science of operations and GCO’s voice to ensure that the development strategy is operationally executable, thus contributing to both GCO and GDD DU mid to long term success.
- Is a key contact to senior leaders in GCO and beyond. Empowered to manage stakeholders, resolve conflict, and facilitate agreement.
- Actively monitor evolution and trends in Biopharmaceutical industry and may represent GCO and Novartis at Industry consortia.
- May be a member of Early Program Teams, providing an early and proactive assessment of operational viability of new clinical programs and ensuring that GCO’s assessment is correctly reflected in the overall program plans.
- In partnership with the GCO DU Head ensure that novel programs are reflected in the mid-long term GCO strategy and that GCO is prepared for their operationalization.
- The COPH champions a product oriented agile mindset, fostering a culture of experimentation combined with accountable delivery and overall high performance.
Essential Requirements:
- Bachelors in life science/healthcare required; Advanced degree or equivalent education/degree in life sciences/ healthcare preferred (PhD/MD/ PharmD/ Masters) and 10+ years relevant experience in pharmaceutical drug development.
- Experience in managing associates globally and in management in a matrix organization.
- Proven ability to lead cross functional matrix teams applying product-oriented agile ways of working.
- Strong leadership, interpersonal and problem-solving skills. High resilience and ability to advocate and implement new ways of working.
- Extensive knowledge of clinical development processes, preferably extensive knowledge of Novartis late-stage development processes or high likelihood to develop it within 6 months after appointment.
- Proven ability to lead in times of organizational transformation and to lead across organizational boundaries.
- Strong knowledge of therapeutic area or high likelihood to develop it within 6 months after appointment. Strong matrix management skills for bridging stakeholders (business, scientific, technical)
- Strong relationship-building skills; can influence, negotiate with and motivate executive leadership
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Skills Desired
Clinical Research, Clinical Trials, People Management, Program Management, Regulatory Compliance, Resource Management (Organizational), Risk Management