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Clinical operations lead

Bristol-myers Squibb

This is a Full-time position in Princeton, NJ posted April 23, 2019.

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 operational oversight and leadership for the execution of Non-Registrational Data Generation body of work (both BMS Sponsored and non-BMS Sponsored) Key Responsibilities and Major Duties: Senior-level clinical operational leader who drives and leads the successful execution of all operational components of a large-scale global program using strong project management, leadership and organizational skills.

Excellent communication skills required.

Accountable for operational execution to support a diverse portfolio of work across BMS and Non-BMS programs.

Proactively addresses and manages risks and issue escalation.

May contribute to the development of clinical operational strategy.

When appropriate, develops operational plan aligned with Medical or HEOR objectives NRDG work.

Accountable for collaboration and standards of indications in line with registrational and earlier-phase development teams.

Represents GCO Strategy organization as a core member within applicable Medical/HEOR Teams.

Serves as key GCO NRDG operational point of contact for the programs and respective clinical trials.

Drives the development of NRDG operational program level documents.

Inclusive in communicating strategy and decision making across a matrix team.

Demonstrates proactive, financial stewardship of their clinical programs while effectively leading a large global team of individuals assigned to the program.

Qualifications: BS/BA Degree required.Advanced degree is preferred.

Candidate must have approximately 8-10 yrs.

of experience in clinical drug development.

Oncology experience preferred but not required.

Strong leadership competencies and influencing skills with senior leaders and cross-functional leaders in a matrixed environment.

Effective oral and written communication skills to influence decisions, inform and guide a large global operational team.

Broad clinical operational experience (registration and/or post-approval) and strong project management skills.

Ability to foster partnerships across projects and multidisciplinary teams.

Working Conditions: Travel Required (nature and frequency, Occasional for meetings and/or training sessions.

Mostly inter-site travel, Overnight Absences Required (per typical month) 2-4 overnights per month Program Management Proactive gap analysis to identify areas for training, improvement or reduce.

cost/improve efficiencies in the operating model.

Develops project and operational standards and ensures consistency and efficiency across early asset programs.

Provides connectivity and knowledge sharing with registrational and early-phase indication teams.

Manages a disciplined approach that supports accurate, compliant documentation of the team’s work.

Leads and supports cross-functional teams to ensure successful and efficient execution of studies from start up to completion.

Integrates lessons learned across their program work as well as support a global, organizational global awareness.

Supports the team in the using the Risk Based Monitoring methodology or other tools provided (as applicable).

Advises and serves as a Subject Matter Expert (SME) resource for a broad range of organizational-related issues requiring clinical knowledge and operational knowledge.

Acts as an operational SME across R&D (eg: Development and Medical Teams).

Works with GCO functional management and across R&D to secure necessary resources to support the program needs.

Achieves results by effective mobilization, development and utilization of resources.

Provides input (as needed) to Health Authority or other regulatory submissions.