Clinical Development, Medical Director - Type 1 Diabetes Surgeon
Job DescriptionGeneral
Summary:
The Clinical Development Medical Director will serve as the Surgical Lead for clinical trials, working with cross-functional teams on Surgical and trial strategy, design, execution, and reporting.
In addition to oversight and accountability for the study as a whole, this role will serve as the internal primary surgical lead accountable for subject surgery, monitoring the safety of enrolled subjects and ensuring scientific integrity.
The incumbent may participate in other projects to support the clinical development program.
Key Duties and
Responsibilities:
Participates in the development of Surgical manual, Study Protocols, Investigator's Brochures, Clinical Development Plans and other key documents in conjunction with other line functions and with minimal guidanceServes on cross-functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve efficient, high-quality study executionParticipates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriateProvides scientific and clinical input to study-related documents and analysis plans including informed consent forms, clinical research forms, statistical analysis plans, clinical pharmacology analysis plans, and clinical study reportsActs as liaison between Clinical Development and other internal groups at Vertex (e.
g.
, Research, Regulatory Affairs, Clinical Development Execution) for assigned studiesRepresents Vertex to outside medical personnel in the development of clinical protocols, in study conduct, and in external reporting of study resultsPerforms other duties as assigned related to other aspects of Clinical DevelopmentKnowledge and Skills:
Strong oral and written communication skillsAbility to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriateGlobal clinical research experience and experience interacting with regulatory authorities is a plusWorking familiarity with analysis of research data, biostatistics, pharmacology and pharmacokinetics, international standards for Good Clinical Practice (GCP), clinical study design, ethics committee/Institutional Review Board review, preparation of manuscripts, abstract/posters, and oral presentations, overall drug/device clinical developmentBoard certification/eligibility, as well as clinical training in a relevant medical specialty is highly desiredEducation and
Experience:
MD, DO or equivalent ex-US medical degreeGeneral surgery experience required, experience in trauma/abdominal wall surgery is a plus8 years of basic or clinical research experience in an academic and/or industry settingTravel:
30% Domestic and InternationalIn 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 Clinical Development Medical Director will serve as the Surgical Lead for clinical trials, working with cross-functional teams on Surgical and trial strategy, design, execution, and reporting.
In addition to oversight and accountability for the study as a whole, this role will serve as the internal primary surgical lead accountable for subject surgery, monitoring the safety of enrolled subjects and ensuring scientific integrity.
The incumbent may participate in other projects to support the clinical development program.
Key Duties and
Responsibilities:
Participates in the development of Surgical manual, Study Protocols, Investigator's Brochures, Clinical Development Plans and other key documents in conjunction with other line functions and with minimal guidanceServes on cross-functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve efficient, high-quality study executionParticipates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriateProvides scientific and clinical input to study-related documents and analysis plans including informed consent forms, clinical research forms, statistical analysis plans, clinical pharmacology analysis plans, and clinical study reportsActs as liaison between Clinical Development and other internal groups at Vertex (e.
g.
, Research, Regulatory Affairs, Clinical Development Execution) for assigned studiesRepresents Vertex to outside medical personnel in the development of clinical protocols, in study conduct, and in external reporting of study resultsPerforms other duties as assigned related to other aspects of Clinical DevelopmentKnowledge and Skills:
Strong oral and written communication skillsAbility to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriateGlobal clinical research experience and experience interacting with regulatory authorities is a plusWorking familiarity with analysis of research data, biostatistics, pharmacology and pharmacokinetics, international standards for Good Clinical Practice (GCP), clinical study design, ethics committee/Institutional Review Board review, preparation of manuscripts, abstract/posters, and oral presentations, overall drug/device clinical developmentBoard certification/eligibility, as well as clinical training in a relevant medical specialty is highly desiredEducation and
Experience:
MD, DO or equivalent ex-US medical degreeGeneral surgery experience required, experience in trauma/abdominal wall surgery is a plus8 years of basic or clinical research experience in an academic and/or industry settingTravel:
30% Domestic and InternationalIn 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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