Executive Director Clinical Development amp Quality Operations

Profile

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.

The Executive Director, Clinical Development & Quality Operations is a critical management position within the R&D Quality organization that is responsible for the development and strategic oversight of the Therapeutic Area Quality, Vendor and Data Quality as well as Quality Risk Management. Key responsibilities of the Executive Director, Clinical Development & Quality Operations include 1) Oversees the quality strategy across Therapeutic Areas; 2) Defines and implement the quality strategy for vendor selection, management and oversight; 3) Drives Quality Risk Management and Data Quality activities in Clinical Development.

Key Responsibilities


Build and lead a Global Quality Strategy organization that provides experienced Quality Assurance support for Clinical Development projects and processes
Ensure development and implementation of a quality strategy to cover data quality and vendor quality
Oversee vendor quality oversight activities and manage external quality (e.g. quality agreements with CROs, set up of quality councils)
Oversee the incorporation of new technology and innovation (biostatistics, digital biomarkers, data management, eConsent, eMedical Records ) in clinical trial quality
Drives the continuous improvement of Data Quality and Data Integrity within R&D
Oversee Quality strategy across all Therapeutic Areas (Oncology, Cardiovascular, Hematology, Immunology; Cell Therapy and Fibrosis)
Promotes Quality by Design for non-clinical and clinical protocols
Ensures submission and inspection readiness
Drive the R&D Quality Risk Management System
Promotes high standards of quality, compliance, and process excellence through oversight of procedure development/enhancement as well as by leading or contributing to supportive initiatives to ensure delivery of business
Oversees the development and implementation of the digitalization strategy for R&D Quality including automation, virtual reality and chat bots.
Engage with executive management and cross functional business partners to identify areas of greatest compliance risk and obtain information and feedback relevant to process improvement; drive issue resolution
Ensure rapid communication of quality issues, including potential misconduct or issues of significant deviations with project/products, to Health Authorities, business partners and senior management


Qualifications


B.S. and/or M.S. in Chemistry, Biology, or Health related field
Minimum of 12-15 years of progressive responsibility in biopharmaceutical, GCP-related quality environment with a track record of success in managing compliance or quality-related teams and projects
At least 5 years people management experience with demonstrated effectiveness as mentor, coach, leader; demonstrated ability to develop internal talent and hire/manage talented individuals
Proven track record of building/ maintaining high-performance teams/organizations and influencing/ motivating global teams to achieve results-delivering on business and program goals
Exemplary leadership / influence management skills with ability to foster partnerships in the matrix organization across functional/geographic/cultural/partner boundaries
Demonstrated strong knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance
Exhibits strong leadership and management qualities including functional and cross functional team building, strong credibility and conflict resolution
In-depth knowledge of applied risk-management including risk assessment, risk analysis, risk evaluation, risk reporting and communication, risk treatment and the review of continuous risk management
Expert understanding of the overall audit process including design, conduct, reporting, and translation of findings into CAPAs that mitigate risks
Extensive experience in regulatory inspection preparation, management, and related follow-up
Proven track record of building/ maintaining high-performance teams/organizations and influencing/ motivating global teams to achieve results-delivering on business and program goals
Exemplary leadership / influence management skills with ability to foster partnerships in the matrix organization across functional/geographic/cultural/partner boundaries
Demonstrated strong knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance
Exhibits strong leadership and management qualities including functional and cross functional team building, strong credibility and conflict resolution
In-depth knowledge of applied risk-management including risk assessment, risk analysis, risk evaluation, risk reporting and communication, risk treatment and the review of continuous risk management
Expert understanding of the overall audit process including design, conduct, reporting, and translation of findings into CAPAs that mitigate risks
Extensive experience in regulatory inspection preparation, management, and related follow-up
Strong understanding of financial/budgeting and resourcing principles and utilization of this knowledge to make sound business decisions.
Demonstrated analytical and conceptual capability-including capacity to develop/translate long-range strategic plans into short-range operational processes/systems/goals and ability to make sound decisions/recommendations with global perspective
Proven problem-solving skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution
Proficient at creating and communicating a clear vision among team members and effectively aligning resources/activities to achieve functional area and/or organizational goals
Communication Skills: Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers; excellent presentation skills for compelling peer and Senior Management communication
Project Management: Must be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines
Organizational/Time Management skills: Must be able to effectively prioritize, multi-task and work under pressure - and promote the same across the team
Considers global influences, situations, and implications when making plans or decisions, solving problems, or developing strategies
Communicates a clear and compelling vision and strategy for the business
Responds resourcefully to changing business conditions and opportunities, proactively looking for ways the organization can adapt its plans, tactics, or strategies
Anticipates future organizational needs when selecting and developing talent (e.g., develops successors and talent pools for key positions)
Delegates effectively, pushing responsibilities down to the appropriate level and focusing own time on high priority, strategic issues
Fosters a culture in which people continually work to improve services, and work processes


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.

Company: Bristol-Myers Squibb

Req Number: R1527014_EN

Updated: 2020-07-13 00:00:00.000 UTC

Location: Princeton,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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