- Defines a clinical development strategy and prepare the clinical development plans, in conjunction with other relevant functional areas
- Participates 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 guidance
- Leads the Project Team, and works with cross-functional team members to define a project strategy and ensure execution against approved strategy
- Participates 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 appropriate
- Interfaces with regulatory authorities as appropriate
- Monitors and/or oversees medical monitoring of clinical studies
- Participates in business development and strategic planning activities
- Acts as liaison between clinical development and other internal groups at Vertex for assigned studies
- Provides medical and development leadership for cross-functional teams
- Serves on cross-functional study teams for assigned trials, working with other team members to achieve efficient, high-quality study execution, and data analysis
- Represents Vertex to outside medical personal in the development of clinical protocols and study conduct
- Global clinical research experience, and experience interacting with regulatory authorities is highly desired
- Ability to work collaboratively in a fast-paced, team-based matrix environment
- Ability to work independently to resolve challenges
- Enterprise-wide thinking and ability to work in ambiguity
- Ability to ensure the completeness of team work
- Excellent oral and written communication skills
- MD, DO or equivalent ex-US medical degree
- Board certification/eligibility in a specialty is highly desired
- 12 years Pharmaceutical/Biotech industry experience, including time managing clinical trials and clinical development programs, or the equivalent combination of education and experience
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Clinical Development Senior Medical Director - Boston, MA, United States - Vertex Pharmaceuticals
Description
Clinical Development Senior Medical Director - Type 1 Diabetes page is loaded
Clinical Development Senior Medical Director - Type 1 Diabetes
Apply locations Boston, MA time type Full time posted on Posted 3 Days Ago job requisition id REQ-21735Job Description
General Summary:
The Senior Medical Director will define the clinical development strategy of an asset, work with cross-functional multidisciplinary teams to define overall asset 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:
Knowledge and Skills:
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
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locations Boston, MA time type Full time posted on Posted 30+ Days AgoVertex 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 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.
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