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Clinical Development Associate Medical Director, Pain
2 months ago
Clinical Development Associate Medical Director, Pain page is loaded Clinical Development Associate Medical Director, Pain Apply locations Boston, MA time type Full time posted on Posted 30+ Days Ago job requisition id REQ–22480
Job Description
General Summary:
Vertex Pharmaceuticals is searching for an Associate Medical Director to help develop the next generation pain treatments in the Pain Program. You will work as part of multidisciplinary cross–functional study teams on clinical trial design and execution and serving as the primary or back–up Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials. You will work on multiple clinical trials and may also participate in other selected projects in the Pain clinical development program.
Key Duties and Responsibilities:
Provide input into study protocols, investigator brochures, and other study related documents in conjunction with other line functionServe on the cross–functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve efficient, high–quality study executionParticipation in the preparation of regulatory documents in support of regulatory submissions, including the clinical section of INDs/NDAs and CTAs, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and ethics committees/IRBs, and other documents, as appropriateProvide 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)Liaison between Clinical Development and other internal groups within Vertex (e.g., Regulatory Affairs and Clinical Development Execution) for assigned studies, as well as represent Vertex to outside medical personal in the development of clinical protocols and study conductPerform other duties, as assigned, related to pain clinical programsTravel to study sites for qualification or initiation visits or to investigator meetingsEducation and Experience:
MD, DO or the international equivalentBoard certification/eligibility in anesthesiology, surgery (surgical subspecialty) neurology, psychiatry, internal medicine or another relevant medical field is highly desired; clinical development/experience in neuropathic pain is a plusMinimum of 8 years of basic or clinical research experience in an academic or industrial setting, or 4 years post–residency training, designing and executing clinical trials and working with cross–functional teams with experience in analysis of research data and scientific publicationsAbility to work collaboratively in a fast–paced, team–based, matrixed environment and to function independently, as appropriateUtilize novel and creative methods to independently resolve clinical development problemsWorking knowledge of GCP, biostatistics, data management, clinical operations and clinical pharmacokinetics to support trial design and executionExperience in analysis of research data and publicationsExcellent verbal and written communication skillsA desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and societyAbility to travel (25%) to support program activities as neededFlex Designation:Hybrid–Eligible Or On–Site Eligible
Flex Eligibility Status:
In this Hybrid–Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On–Site: work five days per week on–site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Program and may be changed at any time.
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) Clinical Development Associate Medical Director, Pain locations Boston, MA time type Full time posted on Posted 17 Days Ago Clinical Development Associate Medical Director, Nephrology locations Boston, MA time type Full time posted on Posted 30+ Days Ago Clinical Development Senior Medical Director, Hematology locations Boston, MA time type Full time posted on Posted 17 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 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.
