Bristol-Myers Squibb Company

Clinical Operations Lead

Location
Princeton, NJ, US
Posted
Sep 10, 2018
Ref
R1508220
Required Education
Bachelors Degree
Position Type
Full time
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.

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 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.
• 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), 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

Competencies - knowledge, skills, abilities, other

Program Management
  • Develops project standards and ensures consistency and efficiency across the program
  • 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 FDT (Full 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 Clinical Development Team (CDT) and Operations Team meetings; active participant and GCO representative on the FDT
  • 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 that must be used independently and without assistance (e.g., Microsoft Suite)

BMS Systems: ECLIPSE, CARA

Enterprise Applications: SharePoint, SAP, Microsoft Suite

BMS BioPharma Behaviors Required
  • Passion
  • Innovation
  • Speed
  • Accountability


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
  • Describe exposure to any hazards/disagreeable conditions in the work environment - Not applicable

Experience in working in collaborations or with co-development partners preferred

Degree/Certification/Licensure

BS/BA Degree with approximately 10 years of pharmaceutical or biotech experience in a clinical drug development setting. Advanced degree is preferred.

  • Experience - Responsibility and minimum number of years
  • Candidate must have a minimum of a BA or BS Degree with approximately 8-10 yrs. of experience in clinical drug development.
  • 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 teambuilding skills and ability to foster partnerships across projects and multidisciplinary teams.


D07- Clinical Operations Lead

Minimum of 8 years of direct experience independently leading and managing global clinical trials in the Pharmaceutical industry

D08- Senior Clinical Operations Lead *

At least 10 years of direct experience with independently leading and managing global clinical trial program(s) plus 3-5 years in a senior leadership position directing the operations of a large-scale global team and developing and mentoring junior colleagues

*key considerations: breadth of experience in complex clinical trials, leadership skills, adaptability, level of independence