Associate Director, External Data Acquisition

Clinical Dev

icon-location-marker Princeton - NJ - US
icon-location-marker Celgene - Berkeley Heights - NJ
Posted 45 days ago Full_time R1518894

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.

Summary

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

Role Responsibilities

Providing leadership for the acquisition of external (non-CRF) clinical trial study data across multiple clinical development programs.  

Working with a variety of functional teams to define the requirements and process for external data acquisition to ensure data is received using a standard process with secure tools and made available to the appropriate groups to support timely data review. 

Defining the right technical solution to support the external data acquisition process to ensure security and data integrity.

Managing the book of work for external data acquisition to ensure timely acquisition of data and dispersion to the broader organization. 

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 acquisition of non-CRF clinical trial data.

Holding accountability to resolve issues and proactively develop solutions, within the functional and across functions; driving resolutions and communicating well with other groups to do so.

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

Ensuring effective quality oversight and management of external partners (e.g. Function Service Providers, CROs, technology providers, etc.) should they be engaged to perform data acquisition services 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 data acquisition.

Qualifications

Bachelors degree required with an advanced degree preferred. 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 and clinical data flow between systems with proven expertise in external data acquisition processes and technologies.

Strong experience with industry leading eCRF and external data acquisition tools (e.g., Medidata Rave, Oracle, SAS, sFTP, Unix, clinical data warehouses, data lakes, etc.) and well versed in industry trends and emerging technologies supporting external data collection.

Strong knowledge of GCP/ICH guidelines, particularly for data security and integrity.

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

Strong ability to communicate technical solutions to non-technical functions and collaborate to define solutions that meet the needs of various groups.

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.

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.