Director, Clinical Science Operations & Planning

Overview:

The Global Clinical Science Operations and Planning Excellence group (GCOE) is a function that belongs to Global Clinical Science Operations Organization and is responsible for driving and monitoring clinical compliance, inspection readiness, tracking and reporting performance metrics, managing processes and procedures, vendor sourcing,  department budget preparation and monitoring and it includes the Learning and Development group, TMF management and  Records, Global GCP Compliance, Global Process management and Process Transformation.

As a Director, Operations and planning GCOE, you will support the SVP, Global Clinical Science Operations. You will manage GCOE team’s priorities, overseeing internal operations, leading/project managing key projects, and driving culture initiatives. This role will focus on designing, implementing, and deploying a robust GCOE strategy concerning operations and planning that will support Menarini Stemline’s current expanding portfolio and compliance needs. The role will be responsible for ensuring that key projects and initiatives are progressed quickly and to a high standard – while also driving a collaborative culture and striving to achieve strong cross-functional relationships and alignment with senior level stakeholders, data-driven decision-making, and operational excellence in delivery.

You will be an active and engaged leadership team member. You will be flexible and able to adapt to the changing needs of the organization, working together with the Global Clinical Science Operations head to drive continuous improvement in communication, innovation, and process simplification within the Global Clinical Science Operations team and across the matrixed cross-functional organization. Anticipating issues, formulating solutions and ensuring deadlines are met are core responsibilities.

Responsibilities

• Serve as a trusted leader responsible for managing the administrative and strategic functions of GCOE operations and planning.
• Act as an advisor and report to the SVP Global Clinical Science Operations and present to senior leadership team
• Acts as the liaison between the GCOE, other executives, and stakeholders to ensure consistent communication and ensuring involvement or decision-making in a timely manner.
• Ensure timely and effective completion of strategic projects and initiatives.
• Create and maintain systems, business processes and metrics to streamline operations within GCOE, and to support GCOE across the organization.
• Ensure Meeting Effectiveness: Drive agenda setting and allocate time appropriately across topics, provide context to agenda topics, and draft post-meeting minutes and assuming responsibility for follow-up actions
• Lead initiatives and continuous improvement related to business operations, including establishing best practices and assessing key performance metrics Interface regularly with members of the clinical science group (clinical operations, data management and DMPK groups) and other senior leaders. Supporting and driving corporate and enterprise strategy in concert with these leaders will be critical in this role.
  
  

• Bachelor’s degree with 10+ years of relevant experience or Master’s Degree with 7+ years of relevant experience. 
• Great project management skills - organized, disciplined, comfortable following up on actionable / holding people accountable, able to think ahead and catch problems before they arise
• PMP Certification is a plus

• Adaptable, strong listener, comfortable providing feedback 

• Strategic thinker – able to consume large amounts of information, build strategy and communicate key priorities 

• Understands their role of “leading from behind” and leans into this 

• People Oriented - high emotional intelligence, relationship builder, empathetic, works well with different people types 

• Strong Communication skills - clear verbal and written communicator, summarizes information succinctly, able to adapt communication to different audiences 

• Strong PowerPoint creation skills 

• Outstanding time management and experience at performing in the context of a fast-paced biotech, multicultural, global organization where working across boundaries and leading through influence are keys to success
• A deep understanding of systems and processes that support clinical trial execution, harnessing efficiencies and standards that enable business success
• Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.)
• Broad intelligence of the clinical trial environment across key regions, and anticipation of future trends and impact
• Willingness and ability to both manage projects and execute tasks in accordance with business needs. 
• Ability to lead colleague engagement across an organization. 
• Strong leadership, organizational, team development and communication skills. 
• Ability to handle confidential and proprietary information using excellent discretion and judgment. 
• Self-motivated, able to work independently and be reliable and responsive. 
• Ability to be flexible and willing to accept new responsibilities as needed.