Study Scientist CAR-T Global Medical Affairs

17.05. | Employee | 100%

Study Scientist CAR-T Global Medical Affairs

Share This Page Study Scientist CAR T - Global Medical Affairs Operations Medical Affairs Boudry, , Switzerland Full time R1521667_EN 5/6/2020 4:04:16 AM Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. As we seek to progress our innovative CAR T studies (a pioneering treatment for certain Haematological cancers), we are searching for a Study Scientist to join our late-stage Global Medical Affairs team. Based from our International HQ in Switzerland, you will collaborate closely with the Study Medical Lead (Clinical Research Physician, CRP, or Medical Affairs Disease Lead, MADL), and the Study Manager as to action all the clinical and scientific activities of assigned studies. You will guarantee the quality and timeliness of study planning, implementation, execution and close-out – this is in addition to supporting the Study Team with study related clinical/scientific questions and issues. Responsibilities: Review and provide input to the protocol synopsis, and protocol, and support the Study Medical Lead with development of the master Informed Consent Form - this is according to the Clinical Development Plan (and as approved by the Hematology and Oncology Development Committee for Interventional Clinical Trials) Work with the Medical Affairs Internal Review Committee for Non-Interventional Post Authorization Safety Studies (NI-PASS) and Non-Interventional Post Authorization Effectiveness Studies (NI-PAES) as to ensure the Clinical Development Plan is correct Review and provide clinical input to the Statistic Analysis Plan, Monitoring Plans, Risk Management Plan, Case Report Forms (CRFs), edit specifications/checks, CRF completion guidelines, Study Charters and relevant regulatory documents, as required. Lead the development of the Clinical Data Review Plan (CDRP), collating input from all relevant functions, and lead meetings thereof. Ensure that clinical study milestones are aligned from a clinical/scientific perspective and consistent with the clinical program or regulatory authority expectations for NI-PASS and NI-PAES. Contribute to the selection of the final countries and sites, in collaboration with the Study Medical Lead. Support the Study Medical Lead with addressing any clinical / scientific issues arising from regulatory authorities and ethics committees. Provide input into the charters of the Data Monitoring Committee (DMC), Steering Committee (SC) and other committees as required, in collaboration with the Study Medical Lead. Participate and present at external Investigator Meetings and at internal meetings as required. Support the Study Team with scientific expertise at study site initiation and subsequent motivational visits, as required. Support ongoing resolution of issues arising from patient clinical management, e.g., patient eligibility and study conduct, with input from the Study Medical Lead. Provide input into safety data reconciliation. Review data in an ongoing manner, i.e., safety, primary efficacy variables (where applicable), laboratory data and coding issues. Identify trends and follow up on any clinical issues/ discrepancies to be addressed to the sites. Review and provide input into Study Reports, publications, and relevant clinical sections of the Investigator Brochure, as required. Participate in initiatives for ongoing process improvements for Non-Interventional Studies, including PASS/PAES, and take the lead role for initiatives related to the Study Scientist activities, as required. Background Organisational Impact – essential: Work is self-directed; impact is achieved by contributing to Celgene goals Completes routine tasks with little or no supervision; requires direction to complete more complex tasks; work is self-directed; confident in making decisions on minor issues General understanding of role of clinical research Organisational Impact – advantageous: Work is self-directed; Impacts department performance and results Completes routine tasks with no supervision; requires moderate direction to complete more complex tasks; viewed as a subject matter expert in their area; is confident in making non-routine decisions in their subject matter area; Understanding of role of Medical Affairs in clinical research Scientific and Technical Knowledge and Skills – essential: Fundamental understanding of group structure and function. Has general understanding of the principles of clinical trials and/or registries with the ability to effectively engage in operational discussions with internal and external stakeholders Basic understanding of hematology/oncology Solid written and verbal communication skills Scientific and Technical Knowledge and Skills – advantageous: Thorough understanding of group structure and function Has general understanding of the principles of clinical trials and/or registries with the ability to effectively engage in operational discussions with internal and external stakeholders Good understanding of hematology/oncology Proficient written and verbal communication skills Teamwork, Influence and Communication – essential: Ability to engage in effective teamwork. Can effectively interact with contacts who are mostly internal peers or one level higher; External communications usually involve routine matters Teamwork, Influence and Communication – advantageous: Ability to engage in effective teamwork and form team partnerships. Can proactively interact with contacts who are mostly internal peers or one level higher; External communications usually involve routine matters Education and Experience Guidelines – essential: Graduate qualification preferably in medical or science area or equivalent work experience. Minimum 1 year of experience in clinical research or equivalent. Education and Experience Guidelines – advantageous: Graduate qualification preferably in medical or science area or equivalent work experience. Minimum 4 years business experience required preferably in the biotech or pharmaceutical industry. 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 the resources to pursue their goals, both at work and in their personal lives. Working with Us By fostering a culture of inclusion, we empower this 21st century workforce to achieve our company's mission of helping patients to prevail over serious diseases. Explore Job Opportunities A clear purpose. An inclusive culture. The chance to work at the top of your field. These are a few of the reasons Bristol Myers Squibb is the right choice for your next career move. Come Meet Our Team Are you ready for a career where you make a profound difference? We invite you to visit us at one of our events to learn more. For US Applicants Only Bristol Myers Squibb endeavors to make this website accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. The Physician Payment Sunshine Act (Sunshine Act) requires Bristol Myers Squibb to report any transfers of value, including payments made to reimburse interview - related expenses, for candidates who are US - licensed physicians.U.S. licensed Physicians covered by the Sunshine Act include Doctors of Medicine, Osteopathy, Dentistry, Dental Surgery, Podiatry, Optometry and Chiropractic Medicine who are licensed to practice medicine in the U.S.This information will be reported to the Centers for Medicare and Medicaid Services(CMS) on an annual basis and CMS shall post submitted data on its public database.For more information, click here. Bristol 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.For our EEO Policy Statement, please click here . If you'd like more information on your EEO rights under the law, please click here: EEO is the LAW and Supplemental Information. Follow Us Powered by

17.05.2020
Employee, 100%

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Celgene, A Bristol Myers Squibb Company

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Celgene, A Bristol Myers Squibb Company

Route de Perreux 1Boudry

Industry

Healthcare

Year of foundation

1896

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Training Company
Training Company

Celgene, A Bristol Myers Squibb Company

Route de Perreux 1Boudry

Industry

Healthcare

Year of foundation

1896

Labels (1)

Training Company
Training Company
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