Clinical Development Associate Medical Director, Type 1 Diabetes - Military veterans preferred

Clinical Development, Associate Medical Director, Type 1 Diabetes page is loaded

Clinical Development, Associate Medical Director, Type 1 Diabetes

Apply

locations

Boston, MA

time type

Full time

posted on

Posted 3 Days Ago

job requisition id

REQ-22021

Job Description General Summary: The Clinical Development Associate Medical Director will serve as the Medical Lead for clinical trials, working with cross-functional teams on 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 Medical Monitor accountable for 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 Study Protocols, Investigator's Brochures, Clinical Development Plans and other key documents in conjunction with other line functions and with minimal guidance Serves on cross-functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve efficient, high-quality study execution Participates 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 appropriate Provides 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 reports Acts as liaison between Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Development Execution) for assigned studies Represents Vertex to outside medical personnel in the development of clinical protocols, in study conduct, and in external reporting of study results Performs other duties as assigned related to other aspects of Clinical Development Knowledge and Skills: Strong oral and written communication skills Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate Global clinical research experience and experience interacting with regulatory authorities is a plus Working 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 development Board

certification/eligibility,

as well as clinical training in a relevant medical specialty is highly desired Education and Experience: MD, DO or equivalent ex-US medical degree 8 years of basic or clinical research experience in an academic or industry setting, or the equivalent combination of education and experience In this Hybrid-Eligible role, you can choose to be designated as: Hybrid:

work remotely up to two days per week;

or select

On-Site

: work five days per week on-site with ad hoc flexibility. #LI-Hybrid LI-BS1 Company Information Vertex 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. Similar Jobs (5)

Clinical Development, Medical Director - Type 1 Diabetes Surgeon

locations

Boston, MA

time type

Full time

posted on

Posted 30+ Days Ago

Clinical Development, Associate Medical Director, Pain

locations

Boston, MA

time type

Full time

posted on

Posted 14 Days Ago

External Manufacturing Associate Director (Person In Plant) - Cell & Gene Therapy (Type 1 Diabetes)

locations

Boston, MA

time type

Full time

posted on

Posted 3 Days Ago Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and

transfusion-dependent

beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency

. Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit

www.vrtx.com

or follow us on

Facebook

,

Twitter/X

,

LinkedIn

,

YouTube

and

Instagram

. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.

#J-18808-Ljbffr