• Director, Global Medical Affairs, Myeloid Leukemia

    Bristol Myers SquibbSummit, NJ 07901

    Job #1365332474

  • At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a ~~~ preferably board certified in Hematology/Oncology.8+ years industry experience strongly preferred, including expertise in the conduct of clinical trials in hematology/~~~/she will be headquarters based in Princeton or Summit, New Jersey, USA, or Boudry, Neuchatel, Switzerland, and will provide scientific/medical expert input and support for Myeloid launches and approved products, as well as, compounds in various stages of clinical development in that therapeutic area.This individual will lead the design and implementation of integrated global medical plans, under the supervision of the Myeloid Leukemia Disease Lead, Global Medical Affairs, and in coordination with the cross-functional teams.Together, they will take an ownership role in leading the design, planning and execution of BMS-sponsored medical affairs trials (Phases I, II, and III), early access and compassionate use protocols, as well as post-approval observational and interventional ~~~/she will also be responsible for the evaluation and support of investigator-initiated ~~~/she will represent Global Medical Affairs as needed, serving as a Myeloid Leukemia therapeutic area expert in strategic and tactical discussions and presentations with internal colleagues in cross-functional and cross-regional teams, as well as external experts and investigators.Responsibilities will include, but are not limited to, the following:+ Strategic and Tactical Planning: Responsibility for Global Medical Affairs success+ Launch plans for new products or new indication launches in the Myeloid franchise+ Integrated evidence generation plans+ Publication plans+ Responsible for the planning and timely execution of Medical Affairs Sponsored Trials, ensuring excellent standards on compliance, quality, timeliness, budget, and Medical governance. Lead various activities of Global cross-functional teams relating to medical affairs.+ Represent Global Medical Affairs as Myeloid Leukemia area expert in both internal and external venues including regional and Global cross-functional teams, clinical sub-teams, advisory boards, steering committees, investigator meetings, congresses and local symposia.+ Collaborate with Medical Affairs colleagues to define, guide and execute Myeloid Leukemia therapeutic regional strategies and tactics with appropriate use of resources.+ Provide high quality medical input and review of: Disease strategy plans, abstracts, posters, slides, manuscripts, educational materials, IIT protocols, steering committee and advisory board meeting objectives, Medical information letters, Commercial Brand plans, Scientific educational grant requests and patient advocacy grant requests+ Track priority Medical Affairs tactics and performance to goals/budget+ Perform research and analytics and provide recommendations to support quality medical decisions regarding clinical research, consultancy, and internal planning.+ Partner with Scientific Communications on developing timely publication strategy and plan, gap analysis, and key messages.+ Assist with data summaries, preparation for site visits/corporate visits presentations.+ Interaction with key stakeholders, as a therapeutic area medical strategy expert.Internal, including and not limited to:+ Medical Affairs partners in different therapeutic areas+ Global Medical Affairs Leadership+ Marketing+ Market Access+ Clinical R&D+ Statistics+ Translational Research+ Regulatory Affairs+ Project LeadershipExternal, including and not limited to:+ Investigators, KOLs+ Global steering committees+ Scientific Advisory Boards+ Advocacy groups+ Cooperative groupsThe ideal candidate will have:+ Medical Degree, preferably board certified in Hematology/Oncology+ Expertise in hematological malignancies is a strong plus+ A minimum of 8 years industry experience strongly preferred+ Expertise in the conduct of clinical trials in hematology/oncology+ Excellent analytical skills and solid experience in translating medical/clinical information into medical affairs strategies+ Proficiency in critical data review and interpretation+ Excellent oral and written communication skills, including presentations to large groups, facilitation of interactive discussions, and 1:1 discussions with thought leaders+ Knowledge/application of data sources, reports and tools for the creation of solid plans+ Regular travel will be required as neededExpected Areas of Competence:+ Medical lead of clinical studies, with demonstrated decision making capabilities+ Provides medical and scientific expertise to cross-functional BMS colleagues+ Ability to present clearly in scientific and clinical settings+ Conducts medical data review of trial data, including eligibility review.+ Responsible for site interactions in partnership with the Clinical Scientist for medical questions and education (including safety management guidelines)+ Responsible for assessment of key safety-related serious adverse events in partnership with GPVE and oversees safety narratives.+ Collaborates with CS and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion criteria and other safety-related clinical considerations).+ Fulfills GCP and compliance obligations for clinical conduct and maintains all required training for same+ Provides medical accountability and oversight of a group of studies+ Partners with CS to support executional delivery of studies (eg, site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc).+ Identifies and builds relationships with principal investigators. Identifies and cultivates thought leaders (TLs) in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge and design of clinical development studies and programs.+ Maintains a strong medical/scientific reputation within the disease area. Has in depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder.+ Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape+ Provides ongoing medical education in partnership with CS, protocol specific training, to support study team, investigators, and othersAround the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.Company: Bristol Myers SquibbReq Number: R1532075-en-usUpdated: 2020-11-13 00:02:18.385 UTCLocation: Summit,New JerseyBristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.