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 Global Medical Affairs Disease Lead (GMA DL) for Pancreatic Cancer is responsible for developing the Medical Affairs Strategy for all in-line compounds and mid to late-stage compounds in development at Celgene for pancreatic
cancer and other GI cancers. The position is also critical in advancing Celgene's molecular and immunologic research in pancreatic cancer, both in house as well as through external collaborations. In partnership with Clinical Research & Development (CRD) and Translational Development, the GMA DL will develop a research plan for Celgene's collection of more than one thousand patients' tumor samples. The GMA DL will partner with other functions and
regions/countries to drive the development strategy for pancreatic cancer and to ensure that the global hematology and 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. Responsible for monitoring pancreatic cancer research space, disease trends, treatment trends, in-licensing opportunities, and the competitive landscape. Celgene
responsible contact for the top KOLs in the world.
• A core member of the Pancreatic Cancer Disease Strategy Team (DST) which is responsible for:
o Developing the Strategic Disease Plan and making recommendation to franchise governance on long-term and short-term disease priorities,
o Providing a holistic view of the reimbursement and competitive landscape
o Prioritization of compounds within the same indication
o Strategic/commercial evaluation of assets for input into Business Development decision making
o Strategic feedback to the Global Project Teams (GPT), Early Commercialization, and G3M (Medical Affairs, Marketing and Market Access) Teams
o May be appointed DST Lead.
• A member of the related, product specific Global Project Teams, G3M (Medical Affairs, Marketing, and Market Access) Teams and Early Commercialization Teams.
• Lead the creation and oversee the execution of the following strategic global plans:
o Strategic Disease Plan (in partnership with DST)
o Global Publication Plan (in partnership with Global Scientific Communications and Clinical R&D)
o Global Open Data Questions (partner with Project Team Leader, Market Access Lead, Clinical Development and regional/G8 Medical Affairs leads)
o Global KOL Plan (in partnership with regional/G8 Medical Affairs leads)
o Global Training Plan and Platform Materials for Disease State and Products (to be adopted/adapted by the regions)
• Lead research strategy and implementation reflective of Strategic Disease Plan and Open Data Questions that seek to optimize product profile and assure appropriate access to patients world-wide for Celgene products in pancreatic cancer. Work with regional and country Medical Affairs Leads to assure that IITs are designed to address the most relevant open data questions globally, regionally and for each country.
o Lead global Medical Affairs Sponsored Trials (MAST) in pancreatic cancer (see below)
o Lead secondary analyses of primary data from Clinical Research and Development trials (in collaboration with Clinical R&D, Translational Development, and Scientific Communications)
o Provide input into Celgene registries and observational research (protocol development, case report form development, statistical analysis plan, data monitoring, data analysis, and publications) in pancreatic cancer
o Work closely with IKU group and registries groups (US and EU) to analyze real world evidence research involving 3rd Party Databases
• Work closely with Translational Development to gain a deep understanding of the molecular basis of the pancreatic cancer and treatments for pancreatic cancer
o In collaboration with CR&D and Translational Development, develop research plans for Celgene's extensive pancreatic cancer tissue bank.
o Develop partnerships with outside researchers to further the molecular understanding of the pathogenesis of pancreatic cancer and the development of treatment resistance, and the understanding of the immunologic environment
in pancreatic cancer
• Provide strategic guidance to regions and G8 countries regarding the review of Investigator Initiated Trials (IITs) and Cooperative Group study proposals. Review all pancreatic cancer IIT and cooperative study proposals and
participate/vote in respective IRCs worldwide.
• Become the internal expert in GI space including translational understanding (or similar)
• Oversee the conduct of global Celgene Medical Affairs – sponsored (MAST) trials:
o Develop synopsis, assure PRC approval
o Develop protocols
o In close collaboration with Clinical Operations and local Medical Affairs teams, select centers
o Develop Case Report Forms
o Assure enrollment time-lines are met.
o Establish monitoring guidelines for field monitors and Clinical Research Scientist, and oversee data cleaning.
o Prepare SAP in collaboration with Statistics and oversee data analyses
o Oversee publication and presentation of the results at medical meetings
o 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 pancreatic cancer (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
• Drive annual portfolio review of GI IITs, in close collaboration with Global Strategic Planning. Work closely with regional teams, G8 Country Medical Directors, and RML/MSL teams to review the accrual and performance of
approved IITs for GI malignancies, and recommend non-performing studies for closure.
• Partner with Global Scientific Communications to create effective presentations and tools that can be adopted and/or adapted globally (RML/MSL tools, training platform materials, etc.)
• Provide disease and product training in collaboration with regional disease leads to key internal stakeholders
o Review and or provide launch training of RMLs/MSLs, sales force, speaker bureaus 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, Payers, 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 DST at key internal governance bodies, including G3M Steering Committee and HODC
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.*LI-PB1
• Board Certified Oncologist; MD/PhD preferred
• Laboratory expert in pancreatic cancer: deep understanding of the molecular and immunological aspects of pancreatic cancer. Laboratory research in pancreatic cancer extending beyond post-doctoral fellowship preferred.
• Expert in Disease Area with at least 5-7 years of clinical experience in the disease area, and good understanding of KOL landscape.
• At least 7 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.