Clinical Development Medical Director, Nephrology/Inflammation Job Description General Summary: The Clinical Development Medical Director will serve as the Medical Lead for Vertex clinical trials, working with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution and serving as the Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials. The incumbent will work on multiple trials in all Phases of clinical development and may also participate in other selected projects in clinical development.
Key Duties and Responsibilities: 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 sections of INDs and CTAs, 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 Operations) for assigned studies. Represents Vertex to outside medical personnel in study conduct and/or the development of clinical protocols. May lead the development and/or amendments of Study Protocols, Investigator Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions. Performs other duties as assigned related to clinical programs. Knowledge and Skills: Excellent oral and written communication skills. Ability to work collaboratively in a fast-paced, team-based, matrix environment and to function independently as appropriate. Effective at building alliances across functions, based on end-to-end drug development thinking and experience. Education and Experience: MD, DO or equivalent ex-US medical degree. Board certification in nephrology is highly desired. 10+ years equivalent combination of education and experience, with a minimum of 2 years of pharmaceutical/Biotech industry experience in clinical development or as an investigator for clinical trials, including experience managing clinical trial programs. Background in Nephrology, immunology or autoimmune diseases is highly desirable. Experience in analysis of research data and publications; working knowledge of biostatistics; working knowledge of GCP, scientific and clinical research methods and clinical study design. Experience with design, execution, and analysis of clinical trials required. Ability to travel up to 20%, domestic and international is desired. Flex 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.
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.
#J-18808-Ljbffr