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Job Title:
Job ID:14499
Location:Summit, NJ
Offsite Territory:
Full/Part Time:Full-Time
Regular/Temporary:Regular
Category:Medical Affairs
Department:Medical Affairs Leadership - 3609
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.
Prerequisites:
Board Certified hematologist or medical oncologists with 10+ years of experience in the disease area
SUMMARY:
Position is responsible for managing the Medical Affairs Hematology/Oncology Strategy for all in-line compounds and mid to late-stage compounds in development at Celgene for a Disease Area to ensure that the Global Hematology & Oncology community is supported and appropriately informed about the clinical and scientific basis for the therapeutic or clinical research use of our cancer product portfolio in a particular Disease. Responsible for monitoring disease trends, treatment trends, in-licensing opportunities, and the competitive landscape. Celgene responsible contact for the top KOLs in the world.
RESPONSIBILITIES:
- Create and enable the global Disease Strategy for all compounds in the pipeline, working closely with all regional medical affairs stakeholders (N. America, EMEA, APAC, Japan) to synthesize insights and unmet medical needs into a cohesive global strategy. Where regional differences exist, assure that the unique needs of each region are accounted for in the Global Disease Plan.
- Assure alignment of Global Disease Strategy with overall medical and commercial strategy by co-leading Global Franchise Team with the Global Commercial Leader (GCL). Together with the GCL, become the go-to” team in the organization for all issues related to Global Disease Strategy. Lead Celgene by identifying key success factors and obtaining the necessary approvals and resources to assure timely and quality execution of the plan.
- Drive creation and oversee execution of the following strategic global plans:
- Global Publication Plan (partner with Global Scientific Communications) and Clinical R&D
- Global Open Research Questions (partner with Project Team Leader/Clinical Development and GCL)
- Global KOL Plan
- Global Training Plan and Platform Materials for Disease State and Products (to be adopted/adapted by the regions)
- Drive research strategy and implementation reflective of Global Disease Plan and Open Research Questions that seek to optimize product profile and assure appropriate access to patients world-wide for Celgene products relevant to disease. Work with regional Medical Affairs Leads to assure that IITs are designed to address the most relevant open research questions.
- Lead global Celgene sponsored non-registration trials
- Lead secondary analyses of primary data (in collaboration with Clinical R&D)
- Lead registries and Observational Research (oversee protocol, case report form development, statistical analysis plan, data monitoring, data analysis, and publications) in the disease area
- Lead research involving 3rd Party Databases
- Work closely with Translational Development
- In regions without Medical Affairs Leads, oversee conduct of IITs, from discussion of the concept with investigators (in close collaboration with the field RML), to the approval process according to the IIT policy, to timely execution of the contract, enrollment of the patients, and reporting of the results through abstracts, presentations, and manuscripts.
- Oversee the conduct of global Celgene sponsored non-registrational trials:
- Develop synopsis, assure SRC approval of the synopsis
- Develop protocols
- In close collaboration with Clinical Operations, select centers
- Develop Case Report Forms
- Assure enrollment time-lines are met.
- Establish monitoring guidelines for field monitors and Clinical Research Scientist, and oversee data cleaning.
- Prepare SAP in collaboration with statistics and oversee data analyses
- Oversee publication and presentation of the results at medical meetings
- Oversee the drafting of the Clinical Study Report in collaboration with Medical Writing.
- Drive major international Congress Planning, strategically targeting relevant meetings and assuring data for Celgene products meets strategic objectives. Assure excellent preparation for KOL management at specific Congresses.
- Oversee Global KOL Management Process for the Disease state (partnering with Global Strategic Planning and Operations).
- Review key publications(Abstracts, Manuscripts, Posters, presentations etc) and assure that they are consistent with Global Disease Strategy as outlined in Publication Plan, accountable for sign-off of all publications
- Partner with Global Scientific Communications to create effective presentations and tools that can be adopted and/or adapted globally (RML tools, training platform materials, etc)
- Provide disease and product training in collaboration with regional disease leads to key internal stakeholders
- Review and or provide launch training of RMLs, sales force, speaker bureau in collaboration with Regional Disease Leads, Scientific Communications, and Commercial functions
- Coordinate plan for patient access programs ATU, NPP, etc; execution remains at local level
- Key external spokesperson to top global KOLs, Payors, Professional Societies, and Advocacy Groups. Key internal contact and manager for Advocacy groups of global importance.
- Key Member of Business Development team related to disease, driving gap analysis, assessing opportunities, and advocating for specific projects that meet Disease Strategy
- Represent GFT at key internal governance bodies, including FMB, HODC, and PRC
Qualifications and Experience
- Board Certified Hematologist or Oncologist
- Expert in Disease Area with at least 5 years of clinical experience in the disease area, and good understanding of KOL landscape.
- At least 5 years of clinical trial experience, either in academics, cooperative groups, or industry.
- Intimate working knowledge of the role of Medical Affairs within industry.
- Strong interpersonal skills and demonstrated success achieving results through cross-functional matrix teams.
- Good understanding of GCP, statistics, and clinical trial designs.
- Good understanding of commercial drivers of success.
- Experience in and/or accountability for multiple geographies preferred.
- 10+ years of experience academia/industry.
- Travel: Must be able to travel internationally and within US on a frequent basis. Anticipate approximately 30% travel.
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.
Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
*LI-PM1