Clinical Development, Senior Medical Director, T1D Translational Medicine (Transplant Immunology/Endocrinology)
Job DescriptionGeneral
Summary:
The Senior Medical Director, T1D Translational Medicine (Transplant Immunology/ Endocrinology) will define all aspects of T1D translational strategy and will be accountable for delivering key translational milestones.
They will work with cross-functional multidisciplinary teams to define overall translational strategy as well as clinical trials strategy, design and execution, and may serve as the Medical Lead for clinical trials that will be conducted with these compounds.
Key Duties and
Responsibilities:
Defines a clinical development strategy and prepare the clinical development plans, in conjunction with other relevant functional areas (remove repeat of sentence above?)Participate in design and development of T1D metabolic studies, translational medicine expert working cross functionally with research and other functions to design and implement studiesAnalyze data and develop insights to improve outcomes in T1D transplants, identify potential risks and devise immunosuppression strategies.
Collaborate with cross functional teams, clinicians, and researchers to integrate immunological knowledge into clinical practice and improve patient careParticipates in the development of study protocols, statistical analysis plans, investigator's brochures, and other key study documents in conjunction with other line functions and with minimal guidanceParticipates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, safety reports, responses to regulatory authorities, clinical study reports, and other documents as appropriateInterfaces with regulatory authorities as appropriateMedical Monitors and/or oversees medical monitoring of clinical studiesParticipates in business development and strategic planning activitiesActs as liaison between clinical development and other internal groups at Vertex for assigned studiesProvides medical and development leadership for cross-functional teamsServes on cross-functional study teams for assigned trials, working with other team members to achieve efficient, high-quality study execution, and data analysisRepresents Vertex to outside medical personal in the development of clinical protocols and study conductKnowledge and Skills:
Experience in the immunological aspects of organ transplantation including but not limited to islet cell transplant, allo transplant and rejection, immune response modulation, and tolerance inductionExperience in T1D cell therapy, islet cell function/physiology, clinical development is preferredGlobal clinical research experience, and experience interacting with regulatory authorities is highly desiredAbility to work collaboratively in a fast-paced, team-based matrix environmentAbility to work independently to resolve challengesEnterprise-wide thinking and ability to work in ambiguityAbility to ensure the completeness of team workExcellent oral and written communication skillsEducation and
Experience:
MD, DO or equivalent ex-US medical degreeBoard certification/eligibility in a specialty is highly desiredTransplant Immunologist/Endocrinologist with 12
years experience in Immunology/islet cell research, including time managing clinical trials and clinical development programs, or the equivalent combination of education and experienceIn this Hybrid-Eligible role, you can choose to be designated as:
Hybrid:
work remotely up to two days per week; or selectOn-Site:
work five days per week on-site with ad hoc flexibility.
#LI-Hybrid#LI-BS1Company InformationVertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.
Vertex is an E-Verify Employer in the United States.
Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.
com.
SummaryLocation:
Boston, MAType:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
Summary:
The Senior Medical Director, T1D Translational Medicine (Transplant Immunology/ Endocrinology) will define all aspects of T1D translational strategy and will be accountable for delivering key translational milestones.
They will work with cross-functional multidisciplinary teams to define overall translational strategy as well as clinical trials strategy, design and execution, and may serve as the Medical Lead for clinical trials that will be conducted with these compounds.
Key Duties and
Responsibilities:
Defines a clinical development strategy and prepare the clinical development plans, in conjunction with other relevant functional areas (remove repeat of sentence above?)Participate in design and development of T1D metabolic studies, translational medicine expert working cross functionally with research and other functions to design and implement studiesAnalyze data and develop insights to improve outcomes in T1D transplants, identify potential risks and devise immunosuppression strategies.
Collaborate with cross functional teams, clinicians, and researchers to integrate immunological knowledge into clinical practice and improve patient careParticipates in the development of study protocols, statistical analysis plans, investigator's brochures, and other key study documents in conjunction with other line functions and with minimal guidanceParticipates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, safety reports, responses to regulatory authorities, clinical study reports, and other documents as appropriateInterfaces with regulatory authorities as appropriateMedical Monitors and/or oversees medical monitoring of clinical studiesParticipates in business development and strategic planning activitiesActs as liaison between clinical development and other internal groups at Vertex for assigned studiesProvides medical and development leadership for cross-functional teamsServes on cross-functional study teams for assigned trials, working with other team members to achieve efficient, high-quality study execution, and data analysisRepresents Vertex to outside medical personal in the development of clinical protocols and study conductKnowledge and Skills:
Experience in the immunological aspects of organ transplantation including but not limited to islet cell transplant, allo transplant and rejection, immune response modulation, and tolerance inductionExperience in T1D cell therapy, islet cell function/physiology, clinical development is preferredGlobal clinical research experience, and experience interacting with regulatory authorities is highly desiredAbility to work collaboratively in a fast-paced, team-based matrix environmentAbility to work independently to resolve challengesEnterprise-wide thinking and ability to work in ambiguityAbility to ensure the completeness of team workExcellent oral and written communication skillsEducation and
Experience:
MD, DO or equivalent ex-US medical degreeBoard certification/eligibility in a specialty is highly desiredTransplant Immunologist/Endocrinologist with 12
years experience in Immunology/islet cell research, including time managing clinical trials and clinical development programs, or the equivalent combination of education and experienceIn this Hybrid-Eligible role, you can choose to be designated as:
Hybrid:
work remotely up to two days per week; or selectOn-Site:
work five days per week on-site with ad hoc flexibility.
#LI-Hybrid#LI-BS1Company InformationVertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.
Vertex is an E-Verify Employer in the United States.
Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.
com.
SummaryLocation:
Boston, MAType:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
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