Clinical Operations Lead

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.

Purpose/Objective of the Job:

Provide senior-level operational oversight and leadership for the execution of pre-FIH, Phase 1-2 clinical program / clinical trials in Oncology

Key Responsibilities and Major Duties:

• Clinical operational leader who drives and leads the successful execution of all operational components of a large-scale global clinical program using strong project management, leadership and organizational skills. Excellent communication skills required.
• Accountable for operational execution across approximately 10-15 clinical trials and addresses and manages risks and issues.
• Contributes to the development of clinical operational strategy and shapes the clinical development plan.
• Develops operational plan aligned with scientific mechanisms and objectives for early assets.
• Accountable for collaboration and standards of indications in line with later-phase tumor development teams.
• Represents GCO on the Development Team and serves as the key GCO operational point of contact for the program and respective clinical trials.
• Drives the development of program level documents and plans and effectively leads a large global team of individuals assigned to the program.

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Supervisory Responsibility (List job titles of positions that report directly or indirectly to this position and indicate nature of relationship):

Provides Matrix Management oversight for Protocol Managers (PTMs) and Clinical Scientists (CS)

Key Stakeholders/Contacts - describe this position's key internal matrix relationships and key external stakeholders/clients:

Development Team (DT), Operations Team, Medical Surveillance Team (MST), Global Regulatory Sciences and Biometrics (GRS+B), Translational Medicine (TM), All GCO Functional Groups, Clinical Supply Operations (CSO), Collaborative Sciences Research and Operations (CSR+O), Global Quality and Regulatory Compliance (GQRC), External Thought Leaders, Contract Research Organizations (CROs), Oncology, Marketed Product, Medical, Field Medical, and Country Medical Heads/Directors and leadership team members, Advocacy Groups, Investigational Sites, Investigators of Investigator Sponsored Research, External Vendors

List of minimum requirements

• Candidate must have a minimum of a BA or BS Degree with approximately 8-10 yrs. of experience in clinical drug development.
• Scientific and/or laboratory experience preferred but not required.
• Oncology experience strongly preferred but not required.
• Strong leadership competencies and influencing skills with senior leaders and cross functional leaders.
• Effective oral and written communication skills to influence, inform and guide a large scale global operational team.
• Broad clinical operational experience and strong project management skills.
• Proven team building skills and ability to foster partnerships across projects and multidisciplinary teams.

Program Management

• Develops project and indication standards and ensures consistency and efficiency across early asset programs
• Provides connectivity and knowledge sharing with late-phase indication teams.
• Develops operational plans and consistency for execution of translational objectives.
• Manages a disciplined approach to accurate documentation of the team's work
• Consistently uses the PMF principles (initiate, plan, execute, control and close) to manage project progress
• Leads and oversees cross-functional teams to ensure successful and efficient execution of studies from start up to Regulatory submission of differening phases. May include accountability from pre-FIH through CSR.
• Integrates lessons learned across the project
• Supports the team in the using the Risk Based Monitoring methodology
• Advises and serves as an expert resource for a broad range of organizational-related issues requiring clinical knowledge
• Acts as point of contact for operational expertise for EADT (Early Asset Development Team) members and development partners
• Works with GCO functional management and across R+D to secure necessary resources to adequately support the program
• Achieves results by effective mobilization, development and utilization of resources
• Provides input (as needed) to Health Authority submissions

Operational Leadership/Decision making

• Consistently makes operational decisions in a timely manner
• Uses expert judgment to make sound decisions based on a balanced evaluation of available information within a complex environment of competing project priorities
• Acts decisively to address team challenges
• Contributes to business strategy from an operational perspective
• Leads/co-leads the Operations Team meetings; active participant and GCO representative on the EADT
• Facilitates issue escalation and resolution in collaboration with other functional areas
• Actively contributes to issue identification and strategy discussions at senior level meetings

Stakeholder Management

• Addresses the concerns and needs of stakeholders and manages stakeholders' expectations
• Appropriately seeks input before making a decision
• Facilitates issue resolution and communication/collaboration with stakeholders and other functional area team members
• Builds alliances to gain key stakeholder support, buy-in and ownership
• Builds and nurtures partnerships with internal and external team members that develop and maintain trust
• Partners with business leaders to resolve competing priorities and issues related to stakeholder management

Software:

ECLIPSE, CARA

Enterprise Applications: SharePoint, SAP, Microsoft Suite