Clinical Development Senior Medical Director, Inflammation

Job DescriptionGeneral Summary:Vertex is seeking an experienced Senior Medical Director for a leadership role in Inflammation Clinical Development. The individual will work with cross- functional multidisciplinary teams to define overall disease strategy as well as clinical trials strategy, design, and execution, and will serve as the Medical Lead for clinical trials that will be conducted in this therapeutic area. The Senior Director will also engage in analysis, presentation and publications of relevant data.Key Duties and Responsibilities:Serve as the clinical development lead for cross functional activities related to pre-clinical and early through late phase development including development of study protocols and other study related documents, pre-IND and IND submissions and overall clinical development plansParticipate in the development of statistical analysis plans, investigator's brochures, and other key study documents in conjunction with other line functionsLead the Clinical Development Team, and work cross functionally to define a project strategy and ensure execution against approved Disease strategy including a Phase 2 studyParticipate 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 appropriateInterface with regulatory authorities as appropriateRepresent Vertex to external stakeholders including investigators, key opinion leaders, governmental/policy groups, and community/patient advocacy groups as needed for achievement of program goalsKnowledge and Skills:IND filing experienceClinical Development and or clinical/scientific expertise in inflammation clinical development is highly desiredAbility to work collaboratively in a fast-paced, team-based matrix environmentAbility to work independently and creatively to resolve challengesExcellent oral and written communication skillsEducation and Experience:MD, DO or equivalent ex-US medical degreeBoard certification/eligibility in a specialty is highly desired12 years Pharmaceutical/Biotech industry experience, including time managing clinical trials and clinical development programs, or the equivalent combination of education and experienceBoard certification/eligibility in Rheumatology with experience in inflammation clinical development#LI-BS1Flex 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 select2.

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 Flex @ Vertex Program and may be changed at any time.Company InformationVertex 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