Celgene Strategic Project Associate Director, Cellular Therapy in Summit, New Jersey
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.
10 years of industry experience. 5+ years of Project Management. Advanced degree
in life sciences and/or management. Solid experience in clinical or medical affairs in hematology or oncology. Ability to work across a matrix organization. Experience in
the conduct of clinical trials in hematology/oncology a plus.
The Strategic Project Director, Cellular Therapy, US Medical Affairs will report to the Disease Lead of US Medical Affairs and will be headquarters-based. He/she will provide scientific leadership and operational support in creating an integrated US strategic and tactical plan for the various CAR-T programs in Hematology Franchise (e.g. in Multiple Myeloma & Lymphoma). Provides a vital link between CAR-T Leads in US Medical Affairs, Global Medical Affairs (GMA) and Corporate Medical Affairs, to foster cross-communication, strategy alignment, resource planning and process improvement in CAR-T Programs. This individual will support the design and implementation of strategic disease area medical plans as needed. Key activities include managing communication, alignment of strategy and brand planning, harmonizing launch activities, timelines and budget, supporting workforce optimization, process improvement and operational excellency. Provide specific project/ program support as appropriate and may serve as the CAR-T disease expert as needed.
Medical Affairs Strategy and Alignment
Responsible for bringing alignment between various Medical Affairs functions that are involved in the development and commercialization of CAR-T therapies (e.g. in Myeloma and Lymphoma) in the US, and for communicating effectively a clear, consistent and long term Medical view in the US/ Global medical and marketing planning process
Collaborate with US Disease teams (e.g. Myeloma and Lymphoma), review US medical CAR-T launch plans, tactical plans and strategic imperatives for each disease state and ensure a strategic fit between these plans and clinical research enterprise (MAST, CAR T registry, RWD, IITs) supported under US/Global Medical Affairs
Collaborate with US Disease teams, MSL Leadership, Global Franchise teams and Corporate Medical Affairs, understand potential risks and bottlenecks from the field during the planning, launch and implementation phases of the CAR-T Programs. Working with disease teams to plan specific solutions. Communicate proposed solutions and mitigation plans to US Medical Affairs Leadership for review and considerations
Working with US Disease teams, establish and review on regular basis the Open Data Questions (ODQs) for each disease area related to CAR-T programs. In collaboration with Corporate Medical Affairs, tracking objectives of studies managed under Medical Affairs against open ODQs
Partner with Scientific Communications on developing publication strategy, gap analysis, and key messages across both CAR-T Programs. Provide high quality scientific/clinical input and review of: disease strategy plans, abstracts, posters, slides, manuscripts, educational materials, webcasts, IIT protocols, Commercial Brand plans, Scientific educational grant requests and patient advocacy grant requests
Maintain expertise on external CAR-T competitive landscape in the US through medical knowledge, insight gathering and relationships with key customers, to support Disease Leads in implementing a successful CAR-T strategy.
Partner with the US Disease Leads as necessary for various activities of G3M. Represent Celgene at professional meetings, congresses, advisory boards/ steering committees and local symposia.
Interaction with key stakeholders, as a scientific and strategic expert:
Medical Affairs partners in therapeutic area
Global Medical Affairs Leadership
Clinical Research and Development
Global Steering Committees
Scientific Advisory Boards
Budget, Resource, and Timeline Planning
In collaboration with US Medical Affairs Disease Leads and Finance/ Corporate Medical Affairs, support (or manage if needed) the planning of USMA CAR-T timelines, resources, and budgets, and develop risk-adjustment model to allow better forecasting of committed spending. Forecast budget to 3-year timeframe
Collaborate closely with USMA leadership to ensure timelines and budgets are appropriately presented to oversight committees. Track timelines, budget and workforce plans against plans on a quarterly basis
Operational Excellence: Efficiency and Process Improvement
Ensure Lessons Learned and Best Practices are shared between Disease teams (e.g. Myeloma and Lymphoma CAR-T programs) within USMA and with Global and Corporate Medical Affairs
Review the current conduct of CAR-T Programs within USMA and identify activities for optimization (such as service sharing, outsourcing refocusing, delayering, adapting to new technology etc.).
Review Adboard plans and maximize KOLs interactions, operational efficiencies and budget controls
Review field readiness plans and harmonize MM and Lymphoma field activities.
Review CROs/ vendors providing services in USMA and identify areas of improvement
Collaborate with the Learning and Development team to identify appropriate CAR-T training (platform, curricula, content) for department to enhance medical capabilities
The ideal candidate will have the following mix of professional and personal characteristics:
Advanced degree in life sciences area and in management.
Project Management and Study management experience (5+ years) in biopharmaceutical / pharmaceutical industry. PMP certification preferred
Core competency in hematology and oncology (e.g. myeloma and lymphoma), and familiarity with trial designs, statistics, and standard management of oncology and malignant hematologic diseases. Publication history in hematology and oncology space preferred
Demonstrated ability to function in a rapidly changing, highly matrixed organization, leading cross-functional, cross business groups. Ability to influence without authority desired
Experience in conducting pharmaceutical clinical trials, including company-sponsored studies, investigator- initiated studies, registries, and cooperative group
Experience in establishing regional/global medical, publication and brand plans
Knowledge of industry trends and experience in leading and driving operational programs and initiatives
Excellent interpersonal, facilitation, negotiation and communication skills; experience in delivering complex messages to various internal and external customers with a track record of effective and influential presentations
Demonstrated leadership skills, prior experience managing people in multicultural environment
History of working with or for CRO/vendor companies
Proven ability to multi-task; Strong oral, written, and organizational skills
Demonstrated Competencies in analytical thinking, thoroughness, and detail orientation
Experience in leading/directing change management in a dynamic environment
Financial forecasting, budgeting & resourcing skills
Proficiency in scientific and clinical data review and interpretation.
Demonstrated customer focus orientation & credibility with customers.
Process improvement acumen: ability to think strategically. Lean Six Sigma training preferred
Regular travel will be required (approx 25%)
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.