Celgene Director, Clinical Programming - RAVE in Berkeley Heights, New Jersey

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

The Director, Programming will oversee and provide leadership of activities related to clinical trial system for Medidata Rave, connecting modules and associated process/training. This position partners with Platform/System Owner, study teams, CRO and DOP leaders. This leader will have responsibility for building the strategy in the areas of Rave Global Library, Operational data standard usage, and Rave system (including module connections) along with support from direct report experts in the Data Capture and Review area.

They are responsible to work with the various stakeholders on continuous innovative processes improvements and mitigate obstacles that are impacting capabilities including but not limited to data capture and review, medical coding and review.

Responsibilities will include, but are not limited to:

Programming Leadership:

  • Responsible for managing Programming teams and monitor/forecast resources to ensure projects are sufficiently resourced

  • Responsible for performance evaluations and development of direct reports including identifying opportunities for cross functional collaboration

  • Coach/mentor and model behaviors to set examples for programming teams, responsible for the team’s overall performance

  • Manages programming team conflicts to resolution and improve team collaboration

  • Provide training and continued feedback to programming teams to ensure they understand Celgene standards and processes

  • Develop and execute department strategy; model behaviors, implement new technologies consistent with strategy

  • Develop Therapeutic Area programming strategy and collaborate with other functions in regards to programming deliverables (e.g. database design, database library development, standard risk characterization plans)

  • Proactively anticipate problems, identify root causes and implement creative solutions

  • Develop performance metrics to be utilized internally and by CRO partners

  • Leverage networks to achieve influence with others and represent programming in cross functional forums to determine the best course of action

  • Conduct cross functional meetings to gain trust and respect of team members, makes decisions on business issues, and freely challenges and expresses perspectives

  • Work with CROs at the alliance level to set expectations and ensure consistency execution across all CROs, as well as alignment with department/company strategy

  • Work closely with CROs to build/maintain positive relationships, negotiate timelines/budgets, successfully manage conflicts and thoroughly understand the CRO processes

  • Monitor performance of CROs, identify issues as well as process gaps and collaborate with CROs to address the same

Other Key Activities:

  • Develop job descriptions and career paths for the department

  • Ensure consistency and adherence to standards and best programming practices within the department

  • Oversee/Lead the development and maintenance of the Rave database and libraries, Medidata cloud module connections, process as well as training for data capture and review components, as well as validation standard.

  • Oversee/Lead department and/or cross-functional process improvement initiatives, special projects and regularly disseminate information to teams and stakeholders

  • Evaluate and assign resources needed to support initiatives and special projects

  • Independently manage resources and timelines for special projects, and collaborate with other departments and external partners during the execution

  • Author, review, approve and train on department procedures including SOPs, Working Practices and Guidance Documents

  • Represent programming during internal audits as well as Health Authority audits

  • Provide training and continuous feedback to new programmers to ensure their proficiency with Celgene standards and processes

  • Proactively anticipate problems, identify root causes and implement creative solutions

  • Build and stream line inter-departmental relationships and resolve issues as needed

  • Participate in industry wide technical discussions

Skills/Knowledge Required:

  • Strong knowledge of data capture, database design, data processing, programming requirements for drug development and regulatory requirements is required, as well as prior experience in managing the clinical programming function

  • BA/BS degree or equivalent in a relevant scientific discipline with a minimum of 12 years of experience in Clinical Programming or Database Programming

  • Minimum of 7 years of management experience

  • Demonstrates direct and indirect management skills, strong project management skills; good communication skills; ability to work in a cross-functional team environment

  • Experience with Standards Metadata repository for operational and downstream impacts

  • Hands on experience with CDSIC standards including CDASH or SDTM/ADaM

  • Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats

  • Knowledge of cross functional clinical study design. Detailed knowledge and experience in CRF design, central laboratories, programming databases, query resolution, and data validation

  • Understanding of downstream requirements (e.g., SDTM, ADaM, Data Definition Table, e-submission)

  • Demonstrates expertise in the handling and processing of upstream data (e.g., multiple data sources, data workflow, eDC, SDTM)

  • Advanced knowledge of clinical database design and programming practices in Rave

  • Knowledge of Rave data management systems and good understanding of SAS datasets and procedures. Familiar with reporting tools (e.g. JReview, SpotFire)

  • In-depth knowledge of FDA/ICH guidelines, industry/technology standard practices and good programming practices

  • Good understanding of clinical data and pharmaceutical development.

  • Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs

  • Medical or mathematics/computer science background a plus

  • Ability to research new technologies and ensure alignment with regulatory agencies and industry standards

#LI- POST

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.