Job Description

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Operations Portfolio Lead/ ISR Process and Systems SME: The Operations Lead for ISR Process and Systems is a leadership role within Global Development Operations (GDO), Late Development Global Clinical Trial Strategy & Operations (GCTS&O), that reports directly to the Therapeutic Area Head, Oncology. The Operations Lead is an integral member of the GCTS&O organization and will provide insight on strategic direction for ISR management and will be accountable for assisting and driving ISR execution in alignment with the GDO vision. The Operations Lead should possess subject matter expertise, strong communication and collaboration skills, ability to manage multiple projects simultaneously, and ability to exercise influence without direct authority over a continuum of stakeholders. The Operations Lead has a key role in the following: instilling operational discipline by leveraging a quality systems mindset and approach for ISR processes; advancing the vision of GDO capabilities via processes and systems that are customer focused, effective and compliant; and working closely with IT and other business partners to roll-out new and enhanced systems.

Key Responsibilities and Relevant Experience/Skills

Leadership

* Demonstrate understanding of the expectations and vision of GDO/GCTS&O as a science-driven and patient committed organization
* Maintain alignment with GDO leadership and maintain representation for GDO interests in engagement with stakeholders, to ensure that the best operational approaches are selected.
* Stay current with key initiatives across GDO and support GDO leadership colleagues and their teams in achieving deliverables against organizational priorities
* Exhibit a high degree of collaboration with GDO colleagues, Medical Capabilities/Medical Data Generation (MDG) colleagues, Worldwide Medical (WWM) colleagues and other relevant stakeholders to ensure alignment across the broader organization
* Present project updates at GCTS&O leadership team meetings as well as other relevant forums (e.g., Town Halls, Operations Review Meetings)
* Ensure team adherence to all applicable SOPs, work instructions and guidance, workflows, and required reporting
* Exhibit professionalism, deep subject expertise and strong business acumen

Process and Systems

* Partner with GDO Process and Systems team members, Information technology (IT) and the Late Development Business Operations Lead in implementing and maintaining steady state operations systems and technologies
* Guide the development of standard operating processes (SOPs), work instructions and process guides for ISR related activities that are compliant with legal and regulatory requirements, internal policies and industry best practices
* Manage and refresh SOPs, work instructions, process guides and/or best practices as required to improve operational performance and reduce operational risk
* Ensure coordination between regions, Therapy Areas, enabling functions (e.g., GTMM and RCO) and key stakeholders to drive consistency in approach and implementation
* Guide the development of effective training, assessment and remediation frameworks and/or practices to ensure compliance, manage risk, and deliver solutions that focus on business efficiencies while maintaining compliance

Relevant experience and skills:

* Relevant experience in ISR related process and systems, execution and improvement
* Expertise to lead process and systems workstreams and other forums to inform effective, efficient, new and updated processes and systems
* Experience in partnering with business stakeholders across geographies, therapy areas and functions to inform global process design and execution
* Experience working within regulations and compliance requirements
* Deep understanding of the environment, evolution and global nature of the Pharmaceutical Industry
* Strong personal integrity and high ethical standards
* Strong problem-solving and analytical skills with ability to innovate with practical solutions for complex issues
* Ability to organize, prioritize and work effectively in a constantly changing, ambiguous environment
* Ability to work independently while escalating risks and issues as appropriate
* Excellent interpersonal communication (written/oral) and presentation skills
* Change management and project management skills with the ability to work effectively and drive alignment in a global environment

Degree requirements: BA/BS or equivalent degree in relevant discipline

Experience requirements: Minimum of 8 years global experience in clinical drug development or other related experience; Broad clinical operational experience (registration and/or post-approval is a plus)

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.