Group Director, RCO US
The Group Director role will be placed within the Regional Clinical Operations (RCO), Americas organization of Global Clinical Operations (GCO). This role will lead both the US site management and site monitoring teams and is responsible for execution excellence in operational planning, implementation and investigative clinical site management and monitoring of Phase I-IV clinical trials conducted within the US.
This leadership role will serve as a member of the RCO-America's Senior Leadership Team and be part of the GCO extended leadership team. This role will interact with the oncology development teams, field medical, and key BMS stakeholders in order to ensure effective management of US conducted clinical trials. The role will build and maintain strong relationships with clinical trial centers across the US and develop collaborations with external site facing organizations such as SCRS.
This role will support a GCO Quality culture partnering with both the GCO Global Clinical Compliance team as well as the Global Quality and Regulatory Compliance (GQRC) Clinical Trial and Safety group.
Primary responsibilities include:
- Executes clinical trials, as per the US Book of Work. Ensures timely study-start-up and that target subject recruitment numbers and database lock timelines are met.
- Proactively evaluates clinical trial feasibility and site selection by collaborating with the Business Insights and Analytics (BI&A) team to evaluate current metrics and data.
- Manages the US team's workload and support of multiple studies. Provides continuous assessment of resource needs and anticipates and initiates actions in response to multiple/changing demands and priorities.
- Takes a broad business perspective when making decisions. Makes judgements to ensure work is achieved within target timelines. Exercises sound judgement in areas of clinical trial management, resource allocation (headcount and budget targets) and recruitment activities.
- Builds and maintains a highly performing team of highly qualified, US based, research professionals (e.g. Clinical Site Managers, Clinical Site Monitors, Clinical Trial Associates and Administrative Associates) and the respective line managers.
- Managing the hiring, development, coaching, mentoring, performance management and succession planning of staff.
- Ensures effective utilization of Full Service Provider (FSP) resources in the execution of clinical trials conducted in the US.
- Meeting or exceeding project deliverables and initiatives with the highest quality through alignment with senior leaders and key stakeholders through flexible and fluid resourcing.
- Develop, maintain and maximize strong working relationships with peers, senior leaders, key stakeholders and external institutions/networks to influence decisions and achieve optimal results focused on our patients.
- Drive alignment across development programs promoting knowledge sharing, operational issue resolution through close collaboration with key stakeholders.
- Identify, maintain and optimally grow clinical investigative site/Institution/Network relationships through direct/personal and/or group engagements in most impactful manner
- Supports a GCO Quality Culture
- Master or bachelor's degree in Life Sciences, nursing, pharmacy, psychology with broad drug development and global clinical trials experience;
- Minimum of 10 years of experience in people and project management in a pharma/biotech/CRO organization;
- Deep knowledge of clinical trial operations including monitoring methodologies, systems, regulations/compliance (e.g., FDA/ICH/GCP), budget and resource management (>$10M) and site facing engagements;
- Passionate, accountable and innovative critical thinker who balances risk/speed for maximum results;
- Previous experience leading, managing, coaching and developing direct reports;
- Highly organized and motivated possessing excellent communication, interpersonal and presentation skills;
- Demonstrated impactful leadership and influencing skills and the ability to work in a matrixed team environment;
- Strategic agility to apply depth of knowledge of clinical trial execution to goals and objectives across the portfolio;
- Results oriented with proven track record in building strong, collaborative relationships with internal and external stakeholders to manage the US book of work.