Associate Director, External Data Set-up Line Manager

Clinical Dev

icon-location-marker Princeton - NJ - US
icon-location-marker Celgene - Boudry
Posted 33 days ago Full_time R1518883

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

 

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

The Associate Director, External Data Set-up Line Manager is a leadership role with oversight of the external vendor data start up activities and directly contributes to the BMS R&D pipeline.

Responsibilities

Providing leadership of external vendor data start up activities across multiple clinical development programs, overseeing a team of external data set-up management professionals in planning, coordination, and timely delivery of external study data.

Driving the data collection strategies for vendor generated test results, championing consistency across programs and therapeutic areas.

Ensuring adaptive management of a global team through the effective deployment of resources and streamlined processes, ensuring productivity targets, validity and quality of the data gathered in support of the evolving portfolio of BMS products.

Managing the book of work for initial and post-production external vendor data requirements.  Assigning resources to studies and initiatives and regularly monitoring workloads to avoid delays in delivery due to resource constraints.  Forecasting future resource needs based on the book of work.

Providing ongoing feedback, coaching, and career development, including engagement and retention support to staff in order to maximize their potential. Empowering and holding staff to high quality performance and delivery.

Ensuring procedural documents are reflective of industry standards, easily followed, and regularly maintained.

Contributing to the development and application of smart systems and optimal approaches to support the collection of external data.

Holding accountability to resolve issues and proactively develop solutions, within the functional and across functions.

Actively participating in and/or leading continuous improvement activities, defining and implementing the changes required to create industry-leading external data capabilities.

Engaging and energizing employees through communication of goals, priorities and other business critical information as well as focus on employee value proposition, development and retention activities

Developing and promoting a work place culture that values diversity of thought, promotes integrity and creates an atmosphere that supports coaching and fosters accountability.

Ensuring effective quality oversight and management of external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing external data set up activities on behalf of BMS.

Developing strong and productive working relationships with key stakeholders throughout GDMCM, GDO, and BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.

Representing the Company in interactions with key external partners as part of any committee or industry group relating to external data.

Experience Requirements

At least 7 years of global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices. Immuno-Oncology therapeutic experience is highly desirable.

Key Competency Requirements

Strong understanding of the drug development process with proven expertise in external data processes and technologies.

Strong knowledge of industry leading eCRF and external data tools (e.g., Medidata Rave, Oracle, etc.) and well versed in industry trends and emerging technologies supporting external data collection.

Strong knowledge of GCP/ICH guidelines.

Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.

Demonstrated partnership across various collaborative forums, CROs, SMOs and/or local site networks.

Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.).

Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team.

Travel Required

Potential need for periodic travel

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.