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 Phase 1-Phase 2 clinical programs / 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 and executes Phase 2 globalization plan in alignment with clinical development plan and company objectives.
• Contributes to strategy and preparation for go/no-go global expansion and potential registration.
• Drives alignment and connectivity of early asset portfolio with BMS Hubs and collaboration and assessment of clinical trial sites.
• 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)

List of minimum requirements

Degree/Certification/Licensure

• BS/BA Degree with approximately 8-10 years of pharmaceutical or biotech experience in a clinical drug development setting. Advanced degree is preferred.
• Oncology experience strongly preferred but not required.
• Experience with, and demonstrated expert knowledge of, global regulatory, clinical and operational footprints and country markets.
• NDA/BLA filing contribution experience 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 standards and ensures consistency and efficiency across the program
• Develops and executes country/hub operational plan in alignment with BMS objectives and functional partners.
• Maintains and applies strong knowledge of global health authorities and approvals/reimbursement profiles to global operational plan.
• 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 final CSR or Regulatory submission
• 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

Communication

• Provides vision to build partnerships across functional area leadership
• Consistently demonstrates positive attitude about the team's ability to deal with challenges
• Drives issues to resolution; communicates to insure that issues have been worked through to completion
• Applies change management principles to support communication and implementation of integrated change
• Demonstrates diplomacy when interfacing with other functional areas, CROs and other outside vendors.
• Frequently communicates program status to different levels of stakeholders

Development of team members

• Consistently provides accurate, motivating and constructive feedback and coaching to team members
• Invests time in getting to know others to understand their attitudes and views; learns others' style to interact effectively
• Accommodates cultural differences
• Builds high performance teams to align program and company objectives, assesses training needs and recommends training where needed
• Partners with functional management to assess skill sets of and set objectives for each team member to enhance developmental opportunities and career development

Software:

ECLIPSE, CARA

Enterprise Applications: SharePoint, SAP, Microsoft Suite