Associate Medical Director, Clinical Development, Cystic Fibrosis - McDaniel, United States - Vertex Pharmaceuticals
Description
Associate Medical Director, Clinical Development, Cystic Fibrosis (CF) page is loadedAssociate Medical Director, Clinical Development, Cystic Fibrosis (CF)
Apply
locations
Boston, MA
time type
Full time
posted on
Posted 3 Days Ago
job requisition id
REQ-21647
Job Description
General Summary:
The Associate Medical Director will serve as the Medical Lead for Vertex clinical trials in Cystic Fibrosis (CF), working with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution and serving as the primary Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials.
This individual will work on multiple trials in Phases 1 through 3 and may also participate in selected projects in the CF clinical development program.
Key Duties and Responsibilities:
Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key study 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 IND's and CTA's, 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 (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR)
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 personal in the development of clinical protocols and study conduct
Performs other duties as assigned related to AATD clinical programs
Travel up to 30% based on business needs
Education and Experience:
MD, DO or equivalent ex-US medical degree
Board
certification/eligibility
in pulmonary, gastrointestinal medicine, infectious diseases, or another relevant medical field, is highly desired; clinical Cystic Fibrosis experience is a plus
At least - 5 years of basic or clinical research experience in an academic or industrial setting, with experience in analysis of research data and publications; working knowledge of biostatistics and pharmacokinetics; working knowledge of Good Clinical Practice, scientific and clinical research methods and clinical study design
Excellent 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
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
Similar Jobs (5)
Medical Director, Clinical Development, Nephrology
locations
Boston, MA
time type
Full time
posted on
Posted 30+ Days Ago
Medical Director, Clinical Development - Type 1 Diabetes
locations
Boston, MA
time type
Full time
posted on
Posted 11 Days Ago
Senior Medical Director, Global Medical Lead - Medical Strategy -Cystic Fibrosis (CF)
locations
Boston, MA
time type
Full time
posted on
Posted 5 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 andtransfusion-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, visitor follow us on
,
Twitter/X
,
,
YouTube
and
.
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