Celgene Director, Clinical Trial Management in San Diego, California
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.
Position is located in San Diego on Science Park Rd.
Provides strategic oversight and operational leadership for large, complex and/or multiple Early Development, Clinical and/or Medical Affairs [Phase 3b/4] programs with a focus on the development and maintenance of accurate program operational plans including timeline and budgets. Represents Clinical Operations on the Global Project Team, proactively contributes to program(s) strategy development, identifies and supports resolution of program issues, and helps facilitate alignment within GCRDO ad with other functions within Celgene as well as with external partners. Responsible for management and development of direct reports.
Program / Study Oversight
Oversee strategic planning and execution of clinical programs to ensure timely and highly quality project deliverables, including:
Overall strategic management for the planning, execution and reporting of large, complex and/or multiple clinical studies/ programs (phase 1-3) needed to support INDs, sNDAs, NDAs, MAAs and phase 3b/4 studies supporting life cycle management with a focus on const disciplined science.
Interact with study team member to ensure consistent performance and quality of work.
Work cross functionally as required to support appropriate resourcing of study teams.
Strategically assess study/program metrics and ensure implementation of appropriate measures as necessary to support project or program targets/ deliverables.
Interact with other departments as well as cross-functional teams (i.e. Clinical Development Teams, Project Teams), including:
Represent Clinical Operations on assigned Early Development, Clinical, and/or Medical Affairs Project Teams and actively shapes the clinical development and operational strategy/tactics
Identify and recommend solutions to problems and/or discuss issues with personnel and/or process across departments.
Functions as the “go to” Operational leader on the development team and is views as “operational leader” by governance and senior stakeholders on the program
Provide specific project/ study support as appropriate
Therapeutic/ Study Input/ Guidance:
Provide indication specific and operational input to shape study protocol and clinical development plans
Strategic consulting in relation to programs/ studies
Evaluate clinical data trends across studies and support study teams as needed to mitigate risks
Participate in vendors selection and review process
Provide therapeutic guidance and development to ClinOps study team members globally in the assigned therapeutic area/ disease
Budget & Resource Planning:
Drive the early planning of study/ program timelines and budgets through close collaboration with other functions (e.g. Clinical, Clinical Trial Analytics, PSRM, Finance, Data Management, IMSC and other relevant functions)
Collaborate closely with Project Leadership to ensure that timelines and budgets are appropriately presented to governance committees.
Notify Clinical Trial Management Leadership (and other relevant functions) of resource requirements for new studies
Support identification and resolution of issues related to study timelines and budgets
Lead regular (e.g. quarterly) program budget review meetings with Finance and ensure that anticipated budget deviations are flagged.
Review study planning and tracking tools regularly (including study budgets), flag deviations to relevant stakeholders and develop mitigation plans in collaboration with Study Managers and other relevant functions
Provide oversight to direct reports to ensure clinical trial management in accordance with functional guideline/processes, ICH/GCP, as well as applicable regulations/guidelines and SOPs/WPs to support compliance, quality, efficiency and successful completion of operational activities related to key study/program milestones
Build the functional expertise of the department and ensure that adequate program-specific and role-specific training is provided
Develop, coach, motivate, and empower direct reports to have a high degree of accountability for performance and the oversight of the key study and program deliverables
Engage and energize employees through communication of goals, priorities, and other business critical information as well as recognizing and celebrating success and achievements
Facilitate functional talent development, succession planning and performance management processes to ensure that individuals are held to appropriate, consistent standards and that key leadership development and succession plan are established
Serve as resource or mentor on operational issues where appropriate
Provide guidance regarding company policies and procedures
Develop and promote strong collaborative relationships with globally dispersed colleagues within and outside Celgene demonstrating teamwork and leadership skills
Lead and/or actively contribute to continuous improvement initiatives within and outside of GCRDO
Collaborate with colleagues within Clinical Operations and from other Departments to maximize efficiencies, share and apply best practices
Flag potential process improvement opportunities and support execution
Knowledge and Skill Requirements:
Experienced clinical R&D professional with knowledge of industry trends and experience in leading and driving operational programs and initiatives
Disease/ therapeutic knowledge/ expertise highly desirable
Financial forecasting and budgeting skills & resourcing skills
In depth knowledge of ICH/GCP, regulatory guidelines/directives and drug development process
Comprehensive expertise in drug development, including solid knowledge of interfaces and interdependencies of clinical development with other functions (e.g. nonclinical & pharmaceutical development, regulatory, commercial marketing)
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.