Clinical Operations Lead

Princeton, NJ, United States
Sep 25, 2020
Required Education
Bachelors Degree
Position Type
Full time
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.

Purpose/Objective of the Job:

Provide senior-level operational oversight and leadership for the execution of Phase 1-Phase 2 clinical programs / clinical trials

  • Key Responsibilities and Major Duties:
    • Drives operational strategy and planning for assigned portfolio of work across BMS and/or non-BMS programs.
    • Provides oversight of all clinical studies within assigned portfolio, via effective matrix management.
    • Proactively identifies and manages risks and issue escalation across the assigned portfolio.
    • Represents GDO Strategy organization as a core member within applicable governance forums (e.g. Development Teams).
    • Demonstrates proactive, financial stewardship of assigned clinical programs.
    • Participates and provides input to the vendor selection and review process.
    • Participates in the program/portfolio reviews with CRO partners, as applicable.
    • Strategically assesses study/program metrics and ensures implementation of appropriate measures to support project or program targets/deliverables.
    • Flags potential process improvement opportunities and support execution.
    • Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned.

      List of minimum requirements

    • 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.
      Responsibilities involve a combination of execution and oversight, dependent on the sourcing model, to ensure deliverables and may include, but are not limited to, the following:

      Study Planning and Conduct
    • Drives business strategy from an operational perspective.
    • Accountable for study execution, within established timelines, budget and quality parameters.
    • Acts as primary escalation point for all operational issues.
    • Participates in necessary governing forums.
    • Identifies improvement opportunities and brings forward best practices to support study execution within the portfolio, and across the broader organization.
    • Proactively partners with cross functional counterparts and external vendors to address issues/concerns.

      Financial Planning & Management
    • Accountable for financial stewardship of programs, while working in close partnership with Finance.

      Operational Leadership / Decision Making
    • Drives and/or develops project standards and ensures consistency and efficiency across the studies within the program.
    • 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 study team challenges.

    • Effective oral and written communication skills to influence, inform and guide a global operational team.
    • Builds effective partnerships across functional area leadership.
    • Consistently demonstrates positive attitude about the team's ability to deal with challenges.
    • Drives issues to resolution and communicates to ensure that issues have been worked through to completion.
    • Applies change management principles to support communication and implementation of integrated change.
    • Frequently communicates program status to different levels of stakeholders, including Sr. Leadership.
    • BA/BS or equivalent degree in relevant discipline
    • Minimum 8 years of 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.