Executive Director Clinical Development amp Quality Operations
Location
Princeton, NJ, United States
Posted on
Jul 13, 2020
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
- Oversees the quality strategy across Therapeutic Areas.
- Defines and implements the quality strategy for vendor selection, management, and oversight.
- Drives Quality Risk Management and Data Quality activities in Clinical Development.
- 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.
- Drive the continuous improvement of Data Quality and Data Integrity within R&D.
- Promote Quality by Design for non-clinical and clinical protocols.
- Ensure submission and inspection readiness.
- Drive the R&D Quality Risk Management System.
- Promote 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.
- 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.
- 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 a global perspective.
- Proven problem-solving skills to prevent and overcome complex process and quality-related issues during clinical program implementation and execution.
- 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.
- 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.
Company: Bristol-Myers Squibb
Req Number: R1527014_EN
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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