Clinical Operations Program Head

Job Description Summary

Onsite
Location: East Hanover, New Jersey
Hybrid
#LI-Hybrid

About the role:
The 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.

 

Job Description

Your Key Responsibilities:

• 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.
• In partnership with GCPH and other GCT members, actively offer operational insights and options to contribute to the program and trial strategy, in particular with respect to study design and protocol optimization and timelines planning.
• Act as author and owner of the Operational Execution Plan (OEP). The COPH is responsible for its quality, relevance, and impact on the execution of the trial.
• Ensures that PSP and Study and Site Operations work hand-in-hand through excellent partnership with the Trial Lead through documented planning in the OEP. 
• 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.
• 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.
• Actively monitor evolution and trends in Biopharmaceutical industry and may represent GCO and
• 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.
• Guides members of the organization through the GCO organizational evolution and the evolution of new “product aligned” ways or working and our overall culture. The COPH champions a product oriented agile mindset, fostering a culture of experimentation combined with accountable delivery and overall high performance.

Video Link  

• https://www.youtube.com/watch?v=ggbnzRY9z8w  

Role Requirements:

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, ne