Other Locations:US- NJ- Summit West
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.
Summary/Scope: Supports and interacts with Clinical Research & Development Operations (CR & D Operations) Functional Leadership in the development and validation of feasibility criteria for clinical programs/studies, timeline projection and study specific recruitment and retention strategies inclusive of scenario modeling according to study specific assumptions.
Responsibilities will include, but are not limited to, the following:
Clinical Trial Strategies and Analytics
- Collaborate with Clinical Research and Development Operations functions and cross-functional areas to create clinical trial process modeling focused on study planning and enrollment to drive optimal decision making and management of study risks.
- Lead development of feasibility criteria for clinical programs/studies, timeline projection and study specific recruitment and retention strategies
- Collaborate with Clinical Research and Development Operations functions and cross-functional areas to identify, collect, integrate and analyze internal and external data sets that may better enable the projection of program/study milestones, identification of potential countries and sites, and facilitate subject recruitment and retention strategies and tactics.
- Engages with Regulatory, Commercial and other Celgene functions who evaluate Epidemiological data for the purposes of identifying incidence and prevalence of targeted patient population, inclusive of identifying global vs. regional/local standards of care that must be considered.
- Participate in early identification of potential risks to objectives above and contributes to the development of risk specific contingency plans to promote proactive remediation.
- Participate in root cause analysis and developing and implementing mitigation strategies when needed.
- Develop and recommend program and study level recruitment and retention plans.
- Collaborates with Clinical Operations to develop program/study level subject recruitment and retention strategies.
- Conducts operational analysis and planning to ensure that subject recruitment strategies and tactics identified for a program/study are practical, experienced based and cost effective to execute, inclusive of identification, evaluation, selection and oversight of recruitment vendors.
- Works with local affiliates to ensure compliance with federal and country/local regulations regarding study start up and enrollment strategies.
- Provides project management for the implementation of subject recruitment and retention strategies related to recruitment and media vendors including timelines and budget.
- Participates in root cause analysis and makes adjustments to retention/recruitment planning.
- Responsible for identifying, assessing, introducing and ensuring the application of innovative techniques and tools that enable a data driven country/site selection and subject recruitment/retention processes.
- Analyzes and identifies trends, variations, successfully demonstrated practices, potential problems and opportunities for process improvement.
- Identifies opportunities and fosters collaboration and partnership within organization. Drive Therapeutic Area or function specific interactions with external vendors such as CROs, Investigator networks, Site Management Organizations, hospital or university clinical research units, advocacy groups and recruitment vendors.
- Identifies and supports the use of industry leading tools/templates/systems that enable those processes associated with Protocol Design, industry benchmarking, Project Management, Scenario modeling and probability.
- Participates in and/or oversees retrospective analysis of issues to determine what happened, how many, how often, where the problem is, and what actions are needed within Clinical Research and Development Operations functions and other cross-functional areas.
- BA/BS or equivalent degree preferably in life sciences or allied health field. Degree in mathematics /statistics and life sciences highly desirable.
- At least 5-10 years career experience including 3-5 years of experience in Clinical Research & Development Operations roles
- Familiarity, and preferably proven mastery, of Simulation/Modeling/Algorithm /Forecasting capabilities to enable the creation and management of trial scenario planning, data analytics and correlation analyses using Statistical Methods.
- Experience with the global drug development process/management of clinical studies and current knowledge of GCP/ICH Guidelines and Regulations.
- Advanced Clinical Trial Planning & Execution experience/expertise.
- Analytical mindset with attention to detail.
- Demonstrated administrative and project management abilities in relevant clinical development setting.
- Demonstrated experience managing and collaborating in a team/matrix work environment. Ability to direct activities and influence outcomes without direct authority. Ability to work independently.
- Good verbal, written and interpersonal skills – communication and presentation skills demonstrated in an international clinical research environment.
- Familiarity with process improvement methodologies (e.g. Six Sigma, Lean) a plus.
- Computer and systems literate; familiarity with Microsoft Office programs, including Microsoft Project, WORD, Excel, PowerPoint, SharePoint, Livelink, etc. Familiarity with Minitab or other Statistical computing software is highly desired.
Key (PDI) Competencies:
- Planning: Develops short and long-range plans that are appropriately comprehensive, realistic and effective in meeting goals; integrates planning efforts across work units.
- Develops Systems & Processes: Identifies and implements effective processes and procedures for accomplishing work.
- Listens to Others: Actively attends to and conveys understanding of the comments and questions of others; listens well in a group.
- Displays Organizational Savvy: Develops effective give and take relationships with others; understands the agenda and perspectives of others; recognizes and effectively balances the interest and needs of one’s own group with those of the broader organization.
- Drive for Results: Drives for results and success; conveys sense of urgency and drives issues to closure; persists despite obstacles and opposition.
- Fosters Teamwork: Builds effective teams committed to organizational goals; fosters collaboration among teams; uses teams to address relevant issues.
- Commitment to Quality: Emphasizes the need to deliver quality products and/or services; defines standards for quality and evaluates products, processes and/or services against those standards; manages quality.
- Recognizes Global Implications: Seeks to understand issues, trends and perspectives of various cultures and countries; recognizes that what works in one’s own country will not necessarily work in another; addresses cultural and geographic differences in strategies and approaches.
- Demonstrates Adaptability: Handles day-today work challenges confidently; is willing and able to adjust to multiple demands, shifting priorities, ambiguity and rapid change; show resilience in the face of constraints, frustrations or adversity; demonstrates flexibility.
- Analysis of Issues: Gathers relevant information systematically; considers a broad range of issues or factors; grasps complexities and perceives relationships among problems or issues; seeks input from others; uses accurate logic in analyses.
- Innovation: Generates new ideas; goes beyond the status quo; recognizes the need for new of modified approaches; brings perspectives and approaches together combining them in creative ways.
- Acts Strategically: Balances big-picture concerns with day-to-day activities; stays informed about industry practices and new developments; understandings the organization’s missing and strategies.
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.